Scholar Rock
latent growth factors, monoclonal antibodies, TGFβ biology
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latent growth factors, monoclonal antibodies, TGFβ biology
0-100 chain-logic scale · 15 dimensions · scored on public evidence
A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD
A phase 1 study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SRK-439 in healthy adults
This double-blind, Phase 2, multiple-dose study will be conducted to evaluate the PK/PD, efficacy, safety, and tolerability of apitegromab in subjects \<2 years old with 5q autosomal recessive SMA who have delayed motor milestones for their age attributed to SMA at the discretion of the Investigator or a Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) score \<55.
A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight or obesity
The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.
This Phase 3 trial (Study SRK-015-003) was conducted in patients ≥2 years old at Screening, who were previously diagnosed with later-onset spinal muscular atrophy (SMA) (i.e., Type 2 and Type 3 SMA) and were receiving an approved survival motor neuron (SMN) upregulator therapy (i.e., either nusinersen or risdiplam), to confirm the efficacy and safety of apitegromab as an adjunctive therapy to nusinersen and evaluate the efficacy and safety of apitegromab as an adjunctive therapy to risdiplam.
This was a multi-center, open-label, Phase 1, first-in-human (FIH), dose-escalation, and dose expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SRK-181 administered alone and in combination with anti-PD-(L)1 therapy in adult patients with locally advanced or metastatic solid tumors. The study was divided into 3 treatment parts (Part A1, Part A2, and Part B) and a Long-Term Extension Phase (LTEP).
The TOPAZ study will assess the safety and efficacy of SRK-015 in later-onset Spinal Muscular Atrophy (SMA Type 2 and Type 3) in pediatric and adult patients.
Trial design for the Phase 2 FORGE study evaluating apitegromab in adults with facioscapulohumeral muscular dystrophy - MDA Clinical & Scientific Conference 2026 and tags on every page of your site. --> Register Now --> Home MDA Conference 2026 Registration Rates Agenda Location & Venue Our Sponsors CE Media Information Sponsorships & Exhibits Sponsorship Levels Event Sponsorships Marketing Sponsorships Exhibit Information Patient Advocacy Pavilion Abstracts 2026 Abstract Guidelines 2026 Abstract Library 2025 Abstract Library 2024 Abstract Library 2023 Abstract Library 2026 On-De … Demand Conference About Us About The MDA Conference About MDA Awards MDA Legacy Award for Achievement in Clinical Research The MDA Donavon Decker Community Impact in Research Award MDA Research Momentum Award Future Conferences Contact Us Home MDA Conference 2026 Registration Rates Agenda Location & Venue Our Sponsors CE Media Information Sponsorships & Exhibits Sponsorship Levels Event Sponsorships Marketing Sponsorships Exhibit Information Patient Advocacy Pavilio … Demand Conference About Us About The MDA Conference About MDA Awards MDA Legacy Award for Achievement in Clinical Research The MDA Donavon Decker Community Impact in Research Award MDA Research Momentum Award Future Conferences Contact Us Trial design for the Phase 2 FORGE study evaluating apitegromab in adults with facioscapulohumeral muscular dystrophy Topic: Clinical Trials Poster Number: 308 T Author(s): John Staropoli, MD, PhD, Scholar Rock, Jeffrey Statland, MD, Univers
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Thank you to Scholar Rock for their... - World Muscle Society Facebook Log In World Muscle Society's Post World Muscle Society September 26, 2025 · Shared with Public Thank you to Scholar Rock for their bronze sponsorship of #WMS2025 . We look forward to seeing you in Vienna for our 30th anniversary Congress. All reactions: 1 Like Comment
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Cardiometabolic Disorders | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock is pleased to announce the submission of our Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for our investigational treatment for spinal… | Scholar Rock | 21 comments LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your … ost Scholar Rock is pleased to announce the submission of our Biologics License Application (BLA) to the U.S. Food and Drug Administration seeking approval for our investigational treatment for spinal muscular atrophy (SMA). As we await next steps in the regulatory process, we're proud of the teamwork and mission focus that brought us to this stage. Read more: https://bit.ly/40v9RCe …more 629 21 Comments Like Comment Share Copy LinkedIn Facebook X Joanne Smith-Farrell 1y Repo
SRK-439 Selectively Inhibits Myostatin to Promote Healthy Body Composition During Metformin Therapy | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to c … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Caregiver perspectives on creating possibilities for loved ones living with SMA | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilitie … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock (SRRK) Leerink Global Healthcare Conference 2026 Summary | Quartr Book demo Product Use cases Discover Pricing Contact sales Open app Companies Scholar Rock Leerink Global Healthcare Conference 2026 Scholar Rock (SRRK) Leerink Global Healthcare Conference 2026 summary Event summary combining transcript, slides, and related documents. Leerink Global Healthcare Conference 2026 summary 28 Mar, 2026 Clinical and regulatory progress Achieved positive phase III SAPPHIRE trial results for apitegromab in SMA, meeting primary endpoints with significant motor function improvement in patient
Mo Qatanani, Ph.D. Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Company … nd human genetics from Baylor College of Medicine and completed a post-doctoral fellowship at the University of Pennsylvania School of Medicine. He has a B.Sc. and a M.Sc. in Biology from the American University of Beirut. Return to Management Team Footer Scholar Rock, Inc. 301 Binney Street, 3rd Floor Cambridge, MA 02142 Phone: 857.259.3860 [email protected] LinkedIn X, formally Twitter SCHOLAR ROCK and the S logo are trademarks of Scholar Rock, Inc. © 2026 All Rights R … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock Resubmits Biologics License Application (BLA) for Apitegromab to the FDA - Cure SMA Skip to content Shop Latest News About Us Our Story Mission & Vision Our History Our Team & Partners Leadership Local Chapters National Partners Support & Resources Contact Us Community Support Annual Reports & Financials Publications Media SMA About SMA Overview Describing SMA Genetics Testing & Diagnosis Newborn Screening Living with SMA Overview Newly Diagnosed Infants & Children Teens & Adults Traveling with SMA Carriers of SMA Research Study Opportunities Adap … yer Gift Match Latest News Shop Donate Scholar Rock Resubmits Biologics License Application (BLA) for Apitegromab to the FDA March 31, 2026 / No Comments / Front Page News , Industry Updates , Latest News , Uncategorized Today, Scholar Rock announced that it has resubmitted its Biologics License Application (BLA) to the Food and Drug Administration (FDA) for apitegromab, an investigational therapy for the treatment of people living with spinal muscular atrophy (SMA). Apitegro
Portfolio - ARCH Venture Partners You are using an outdated browser. Please upgrade your browser to improve your experience. Toggle navigation About Portfolio Initiatives Strategic Partnerships Team News Contact Our Portfolio We build disruptive companies. Meet them. Read what our entrepeneurs are saying about ARCH. Agios Pharmaceuticals --> “What defines ARCH is the willingness to think big – to go for bold transformative ideas rather than settle for incremental progress. ARCH is unique in its ability to see the waves before they start to form. They were the initial glue that brought our scie … htful advice. More than other firms, ARCH knows how to identify an opportunity, fund them generously, attract high-quality teams, and build successful and dynamic companies. Vir Biotechnology would not exist without ARCH finding the science and painting the vision that attracted our management team, which is now helping make the vision a reality. Today, ARCH continues to support the company, helping with strategic moves and introducing new ideas and partners.” — George Scango … htful advice. More than other firms, ARCH knows how to identify an opportunity, fund them generously, attract high-quality teams, and build successful and dynamic companies. Vir Biotechnology would not exist without ARCH finding the science and painting the vision that attracted our management team, which is now helping make the vision a reality. Today, ARCH continues to support the company, helping with strategic moves and introducing new ideas and partners.” — George Scango
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Scholar Rock and Gilead Enter into Strategic Collaboration with Deal Value of Up to $1.5 Billion | News & Events | Goodwin Skip to main content Goodwin Expertise People Careers Legal Paralegal Science Advisor Global Operations Team Insights & Resources About Us Our Story The Goodwin Way Opportunity, Inclusion, and Belonging Pro Bono Firm Leadership Locations News & Events Alumni Press Release December 19, 2018 Scholar Rock and Gilead Enter into Strategic Collaboration with Deal Value of Up to $1.5 Billion Professionals Sarah A. Solomon Shannyn Henke Sarah Stoiber Chloe Pletner King … va Launches AHZANTIVE® Aflibercept Biosimilar in Europe Alert June 22, 2026 SEC Proposal Could Eliminate Baby Shelf Restrictions and Expand ATM Program Access For Smaller Companies Alert June 18, 2026 Delaware is Enforcing Its Principal Place of Business Requirement: An Inaccurate Address Can Block Good Standing Certificates Insight June 18, 2026 Royalty Monetization in an Era of Drug Pricing Pressure: How the IRA is Affecting Royalty Monetizations Big Molecule Watch June 16,
S-1 1 a2235501zs-1.htm S-1 Use these links to rapidly review the document TABLE OF CONTENTS INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Table of Contents As filed with the Securities and Exchange Commission on April 27, 2018. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SCHOLAR ROCK HOLDING CORPORATION (Exact name of registrant as specified in its charter) Delaware (State or other jurisdiction of … e current standard of care. In March 2018, we filed an Investigational New Drug application, or IND, with the U.S. Food and Drug Administration, or FDA, for SRK-015, and in April, 2018, the FDA notified us that our Phase 1 first-in-human clinical trial of SRK-015 may proceed. We plan to commence our Phase 1 clinical 3 Table of Contents trial in the second quarter of 2018. The FDA has granted orphan drug designation for SRK-015 for the treatment of SMA. TGF b 1 Our s … to incur net losses in the future. § We will require additional capital to fund our operations and if we fail to obtain necessary capital, we will not be able to complete the development and commercialization of SRK-015 and any future product candidates. § Our business is highly dependent on the success of our lead product candidate, SRK-015, as well as any future clinical candidates that are generated from our other preclinical programs. All of our product candidat … the adoption of some accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of delayed adoption of new or revised accounting standards and, therefore, we will be subject to the same requirements to adopt new or revised accounting standards as other public companies that are not emerging growth companies. 6 Table of Contents THE OFFERING Common stock offered by us … together with our existing cash, cash equivalents and marketable securities, to fund research and development activities for SRK-015 through ; and to fund TGF b 1, BMP6 and other preclinical research and development activities. We intend to use the remaining
Demos: UI Controls and Frameworks --> Demos: UI Controls and Frameworks | DevExpress Chat Now Cart My Downloads Free Trial Log In Products Products MULTI-PLATFORM PACKAGES Universal Subscription Our Best Value – includes over 600 UI Controls, our award-winning reporting platform, DevExpress Dashboard, the eXpressApp Framework, CodeRush for Visual Studio and more. DXperience Subscription Save Hundreds – includes DevExpress UI Controls for WinForms, Blazor, ASP.NET Core (MVC & Razor Pages), ASP.NET Web Forms, MVC 5, WPF, our award-winning reporting platform and CodeRush for Visual Studio. HIGHLI … cumentation Code Examples Demos Training Need help or require more information? Submit your support inquiries via the DevExpress Support Center for assistance. Blogs About Us About Us CONNECT WITH DEVEXPRESS Blogs Events, Meetups and Tradeshows LEARN MORE ABOUT DEVEXPRESS About Us Careers / Job Opportunities News User Comments and Case Studies Our Awards MVP Program Announcing DevExpress Universal v26.1 Developer Express Inc is proud to announce the immediate availability of … ad Download DevExpress WinForms demo applications from GitHub. Outlook-Inspired Application Build apps with the UI elements your customers have come to expect from the world's most popular software suite. Run Demo Dental Clinic Application Create a relatively modern UX – a user experience that can be applied to different industries with minimal changes. Run Demo Stock Market Trader Build WinForms applications that replicate the innovative navigation UI. Run Demo New HTML & … S markup. Run Demo Learn more about HTML & CSS Support Touch-Enabled Hybrid Application Build touch-friendly WinForms applications that meet the evolving needs of your enterprise. Run Demo Fluent Mail Client Application In this demo application we use our Fluent Design Form to replicate Microsoft Mail's UI. Run Demo Help Resources Documentation Online Training Examples Tutorial Videos Getting Started with the Grid Control Getting Started with the Ribbon Control Getting St … UI — Case Study by DataWerkes: Field Services Management Platform (TimeWerkes) Application Security — Documents Are Untrusted Input Application Security — Stronger Hashes and Safer Passwords WPF Demos With over 130 optimized UI controls and libraries, the DevExpress WPF Subscription , can help you create powerful and visually stunning business s
EX-10.13 14 a2235501zex-10_13.htm EX-10.13 Exhibit 10.13 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED OPTION AND LICENSE AGREEMENT BY AND BETWEEN SCHOLAR ROCK, INC. AND JANSSEN BIOTECH, INC. DATED AS OF DECEMBER 17, 2013 [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATM … ake and sell Licensed Product for use in the Field, and Scholar Rock desires to grant such rights to JBI on the terms and conditions set out herein. NOW, THEREFORE , in consideration of the foregoing premises and the mutual covenants contained herein, the Parties, intending to be legally bound, agree as follows: ARTICLE 1 DEFINITIONS The following terms shall have the following meanings as used in this Agreement: 1.1     &# … 0;     “ BLA ” means (a) a Biologies License Application as defined in the FD&C Act and the regulations promulgated thereunder, or (b) a Marketing Authorization Application (“ MAA ”) in the EU, or (c) any equivalent or comparable application, registration or certification in any other country or region. 1.8                   … has a license or sublicense to such right, or property, and has the ability to grant access, license or sublicense to such right, or property, without violating the terms of any agreement or other arrangement with any Third Party in existence as of the time such Party or its Affiliate would first be required hereunder to grant the other Party such access license or sublicense or requiring any payment by such Party or its Affiliates to any such Third Party under any such agre … 60;     “ IND ” means an investigational new drug application filed with the FDA as more fully defined in 21 C.F.R. § 312.3. 1.35                         “ Indication ” means a dise
Scholar Rock tones up for $75m IPO - Global Venturing Global Venturing | Scholar Rock tones up for $75m IPO Where Global Innovation and Capital Meet Home --> Register Login Go Corporate University Impact Full Site Corporate University Impact Daily Deal Round Up: May 25, 2021 Affirm spinoff Resolve raised $60m from investors including its parent company... Find Out More Daily Deal Round Up: May 25, 2021 Affirm spinoff Resolve raised $60m from investors including its parent company... Find Out More Daily Deal Round Up: May 25, 2021 Affirm spinoff Resolve raised $60m from investors including its
Resources | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our C … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
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Posters & Publications Archive | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Pati … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Exhibit Information - MDA Clinical & Scientific Conference 2026 and tags on every page of your site. --> Register Now --> Home MDA Conference 2026 Registration Rates Agenda Location & Venue Our Sponsors CE Media Information Sponsorships & Exhibits Sponsorship Levels Event Sponsorships Marketing Sponsorships Exhibit Information Patient Advocacy Pavilion Abstracts 2026 Abstract Guidelines 2026 Abstract Library 2025 Abstract Library 2024 Abstract Library 2023 Abstract Library 2026 On-Demand Conference About Us About The MDA Conference About MDA Awards MDA Legacy Award for Achievemen … vement in Clinical Research The MDA Donavon Decker Community Impact in Research Award MDA Research Momentum Award Future Conferences Contact Us Home MDA Conference 2026 Registration Rates Agenda Location & Venue Our Sponsors CE Media Information Sponsorships & Exhibits Sponsorship Levels Event Sponsorships Marketing Sponsorships Exhibit Information Patient Advocacy Pavilion Abstracts 2026 Abstract Guidelines 2026 Abstract Library 2025 Abstract Library 2024 Abstract … Demand Conference About Us About The MDA Conference About MDA Awards MDA Legacy Award for Achievement in Clinical Research The MDA Donavon Decker Community Impact in Research Award MDA Research Momentum Award Future Conferences Contact Us Exhibit Information The 2026 MDA Conference Exhibit Hall is now sold out. Please review our full Exhibit Rules here . Exhibit Schedule* Sunday, March 8 ( Welcome Reception in the Exhibit Hall ) 6:00 PM – 8:00 PM ET Monday, March 9 10:15 AM – … st be fully set up by 7:00 PM ET on Saturday, March 7. Exhibitors who miss this deadline will be charged a $1,500 per hour penalty and may forfeit eligibility for future exhibit opportunities. 7:00 AM – 7:00 PM ET Sunday, March 8 All large display crates must be removed from the exhibit floor by 1:00 PM ET on Sunday, March 8 in order for the service contractor to have access to install the aisle carpet. All booths must be complete by Sunday, March 8 at 4:00 PM ET for i … fully set up by 4:00 PM ET on Sunday, March 8. Exhibitors who do not meet this deadline will be charged a $1,500 per hour penalty and may lose eligibility for future exhibit opportunities. 7:00 AM – 4:00 PM ET Patient Advocacy Pavilion Tables Sunday, March 8 1:00 PM – 4:00 PM ET Dismantling of Exhibits Booths (10×10+):
Platform | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Co … iseases with high unmet need while limiting unintended side effects. See how we apply this in practice Footer Scholar Rock, Inc. 301 Binney Street, 3rd Floor Cambridge, MA 02142 Phone: 857.259.3860 [email protected] LinkedIn X, formally Twitter SCHOLAR ROCK and the S logo are trademarks of Scholar Rock, Inc. © 2026 All Rights Reserved Community Guidelines Expanded Access Privacy Policy Terms of Use We are Scholar Rock. A biopharmaceutical company dedicated to discovering … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Confirmed Exhibitors | ICNMD 2026 Skip to content ICNMD 2026 #ICNMD2026 SUBSCRIBE TO MAILING LIST Facebook-f X-twitter Linkedin About Message from the President About ICNMD ICNMD 2026 Committees Congress Secretariat Host Venue Related Events & Partners Past Congresses Future Congresses Contact Program CME Accreditation Program at a Glance Onsite Information Scientific Program Presenter Guidelines Call For Abstracts Patient’s Day Teaching Courses Joint Sessions Registration & Accommodation Registration Accommodation Social Events Sponsorship & Exhibits Sponsorship & Exhibit … n the scientific world, which consists of organising and financing workshops on application basis. enmc.org/ FSHD Society FSHD Society The FSHD Society is the world’s leading patient-driven organization dedicated to facioscapulohumeral muscular dystrophy (FSHD). We accelerate research, improve care, empower patients and families, and build community worldwide. Through education, advocacy, and collaboration, we work to bring effective treatments and a cure to everyone affected
Thank You for Another Fantastic Virtual SMA Conference! - Cure SMA Skip to content Shop Latest News About Us Our Story Mission & Vision Our History Our Team & Partners Leadership Local Chapters National Partners Support & Resources Contact Us Community Support Annual Reports & Financials Publications Media SMA About SMA Overview Describing SMA Genetics Testing & Diagnosis Newborn Screening Living with SMA Overview Newly Diagnosed Infants & Children Teens & Adults Traveling with SMA Carriers of SMA Research Study Opportunities Adaptive Sports & Recreation N
Exhibitor Information Home Membership About Us Leadership Join TNS Today! Meetings & Education Winter Conference Summer Conference Exhibitor Information Other State Opportunities Beyond the Brain: The TNS Podcast Advocacy Making Dementia a Memory! Mobile Stroke Units Committees Get Involved Women Neurologist Section APP Committee Independent Practice Committee Grants Education Foundation Resources For Practice Management FAQ Tool Box Career Center Business of Neurology Video Series Brocas Residents and Fellows APPs Business of Neurology Resident Rotation Member Login Search Join Now 2026 E … ng neurological care in Texas. Download the Exhibit Prospectus Download Exhibit Application for 2026 Annual Conferences Questions? Contact TNS Exhibit & Sponsorship Manager at [email protected] or 512.887.3875 THANK YOU TO OUR 2026 Summer Conference Supporters & Exhibitors AMBASSADOR GOLD BRONZE EXHIBITORS | AbbVie-Chronic Migraine | AbbVie-CNS Migraine | AbbVie Neuroscience | Acadia Pharmaceuticals | Advanced Infusion Care | Alexion Pharmaceuticals | Alexion Pha
Thank you to Biogen, Genentech, Novartis and Scholar Rock for partnering with Cure SMA as Presenting Sponsors and Exhibitors of the 2026 Annual SMA Conference! | Cure SMA LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings . Accept Reject Ag
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Scholar Rock to Present at the 40th Annual J.P. Morgan Healthcare Conference - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opi … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search Genetown Scholar Rock to Present at the 40th Annual J.P. Morgan Healthcare Conference January 4, 2022 | 1 min read Twitter LinkedIn Facebook Email Print Scholar Rock today announced that management will present at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 7:30 a.m. ET. Jan. 4, 202 … bsp; 2 min read · Tristan Manalac Podcast AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more June 24, 2026 · 1 min read · Jef Akst China BIO 2026: US needs to dodge China’s ‘inescapable dependencies’ to protect biotech June 24, 2026 · 2 min read · Annalee Armstrong BioSpace at BIO to find out" href="https://www.biospace.com/drug-development/can-adcs-be-kin … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin
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Cure SMA - Thank you to Biogen, Genentech, Novartis and... Facebook Log In Cure SMA's Post Cure SMA Verified account June 16 at 7:00 AM · Shared with Public Thank you to Biogen, Genentech, Novartis and Scholar Rock for partnering with Cure SMA as Presenting Sponsors and Exhibitors of the 2026 Annual SMA Conference! +4 All reactions: 50 8 shares Like Comment
Spinal Muscular Atrophy | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
What do new possibilities mean to those living with SMA? | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock scores with ‘surprise’ success in SMA drug study | BioPharma Dive Skip to main content CONTINUE TO SITE ➞ Don't miss tomorrow's biopharma industry news Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy . You can unsubscribe at anytime. Informa TechTarget | Healthcare Dive MedTech Dive PharmaVoice Xtelligent Pharma Life Sciences Explor
Scholar Rock SMA drug rejected by FDA over manufacturing concerns | BioPharma Dive Skip to main content CONTINUE TO SITE ➞ Don't miss tomorrow's biopharma industry news Let BioPharma Dive's free newsletter keep you informed, straight from your inbox. Daily Dive M-F Commercialization Weekly Every Wednesday Gene Therapy Weekly Every Thursday Emerging Biotech Weekly Every Tuesday By signing up to receive our newsletter, you agree to our Terms of Use and Privacy Policy . You can unsubscribe at anytime. Informa TechTarget | Healthcare Dive MedTech Dive PharmaVoice Xtelligent Pharma Life Sciences Ex … he disease. In a Tuesday statement, Scholar Rock said the agency turned back an application for the drug, known as apitegromab, due to issues observed during an inspection of a Catalent manufacturing facility in Indiana. That facility, which Novo Nordisk acquired last year, conducts “fill-finish” services for apitegromab. The FDA didn’t cite any problems with the drug’s safety or efficacy, the company said. According to Scholar Rock, Catalent’s Indiana facility responded to t … ctive action.” Once the problems are ironed out, Scholar Rock will resubmit its application and expects the agency to “act expeditiously” to make a decision, it said. “We are continuing to work closely with Catalent Indiana on the FDA’s manufacturing observations so that we can resubmit the apitegromab BLA as soon as possible,” said Scholar Rock chairman and CEO David Hallal in the statement. “We remain focused on working hand-in-hand with the FDA to pursue approval of the fi … ty was involved in a recent regulatory delay for Regeneron. That Scholar Rock’s application was turned back is a “disappointment,” but “not a surprise,” Foroohar wrote Tuesday, adding that the drug’s launch has likely been pushed back to early or mid-2026. Scholar Rock shares fell by double digits in premarket trading Tuesday before rebounding. Add us on Google Share Copy link Email LinkedIn X/Twitter Facebook Print License Filed Under: Biotech, FDA BioPharma Dive news delive
Option Millionaires : Scholar Rock appoints David Hallal as CE... Boards: Quotes: Favorites Popular Monitor Movers Level 2 News Menu Breakout Boards Most Read Most Posted Most Followed Members Active Boards New Boards Site Stats Poststream Ticker Buzz Cloud Boards Stocks Commodities Forex Cryptocurrency The Lounge News All Company News iHub Market News News Scanner Price & News Alerts Market Data Monitor Level 2 Live Charts Trades Portfolio Economic Calendar Follow Feed Trader Alerts Price Alerts Markets Crypto Forex Commodities Futures Discover Market Movers Options Flow Breakouts Scanner Bro … w five-year agreement with the Teamsters Local 237 Welfare and Retirees Benefit Fund, one of the largest Teamsters-affiliated benefit organizations in the United States. The agreement represents another significant milestone for CHS as organizations […] Germany’s Merck to Acquire Bio-Techne in $11.3 Billion Deal Germany’s Merck KGaA has announced a major acquisition agreement to buy U.S.-based life sciences company Bio-Techne Corp (NASDAQ:TECH) in a deal valued at approximate
Manufacturing issues block FDA nod for Scholar Rock SMA drug | pharmaphorum Skip to main content Friday 26 June 2026 BlueSky linkedin youtube header links Get Newsletters Media Kit Pharmaphorum menu first category News Views & Analysis Deep Dive Equity and Sustainability Research & Development Market Access Oncology Artificial Intelligence Patients & Partnerships GLP-1 Previous Editions Webinars Podcasts Videos Spotlight on ASCO BIO-Europe C-Suite Innovators ESMO Frontiers Health JP Morgan Global Policy Insights Events close SECTION News Views & Analysis Deep Dive Research & … of that now, for Scholar Rock, is a delay to approval of the Biologics License Application (BLA) for SMA treatment apitegromab . In a statement, the Cambridge, Massachusetts-based company said that the CRL included no observations that were specific to its drug, such as safety, efficacy, or drug substance manufacturing. "We are continuing to work closely with Catalent Indiana on the FDA's manufacturing observations so that we can resubmit the apitegromab BLA as soon as possi
Scholar Rock has ambitions to serve the SMA community on a global scale. Delivering on that vision takes bold leadership—that's why we're thrilled to welcome Katie Hernandez, MBA as our new Head of… | Scholar Rock | 71 comments LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can up
Skip to main content MedPath Trial Home Trials Products Organizations News Research Pricing Search 中 Login Data Sources: ClinicalTrials.gov EU CTR FDA EMA NMPA TGA Health Canada WHO ICTRP MedPath Trial Home Search trials. Track pipelines. Understand approvals. With AI-powered intelligence for clinical research. Product Clinical Trials Drug Intelligence Global Approvals AI Research Pricing Resources FAQ Search Company News About Contact Legal Privacy Policy Terms of Service Disclaimer: This website provides information retrieval and data analysis services. The content does not constitute medica … on shares of Scholar Rock for $49.37 million, increasing its stake to 16.94% of fund assets. Scholar Rock plans to resubmit its Biologics License Application for apitegromab in spinal muscular atrophy with potential U.S. launch in 2026. The company maintains strong financial position with $365 million in cash runway projected into 2027, reducing dilution risk. Redmile Group Search company , LLC significantly increased its position in Scholar Rock Holding Corporation Search co … fourth quarter according to a February 17, 2026 SEC filing. The biotech-focused fund now holds Scholar Rock as its largest position, representing 16.94% of its 13F reportable assets under management. Strategic Investment Timing The substantial investment comes as Scholar Rock enters 2026 with what the company describes as "a clear catalyst path." According to an announcement last month, Scholar Rock plans to resubmit its Biologics License Application for apitegromab … technology companies focused on drug development rather than commercialization. Fund Concentration Strategy Redmile Group Search company 's investment strategy demonstrates significant concentration in clinical-stage biotechnology names. Following this transaction, Scholar Rock now represents roughly 17% of the fund's assets, alongside other high-conviction biotech positions including Krystal Biotech ($167.08 million), Nurix Therapeutics ($153.54 million), Stoke The … reduce positions around regulatory catalysts. Related Coverage Sources Biotech Fund Doubles Down With $49 Million Scholar Rock Buy as Shares Climb 26% theglobeandmail.com Feb 22, 2026 Biotech Fund Doubles Down With $49 Million Scholar Rock Buy as Shares Climb 26% finance.yahoo.com Feb 22, 2026 Biotech Fund Doubles Down With $49 Million Scholar R
Our Company | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Resources & Information for Medical Professionals | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with se … nd fostering collaborative partnerships with the healthcare community. Jump to: Grant and Sponsorships Investigator-Initiated Studies Publications Support Posters & Publications Expanded Access Additional Resources and Information Contact Do you have a medical question for our team? Contact us at [email protected] or call 1-855-MED-SRRK to connect with Scholar Rock Medical Affairs. Grant and Sponsorships Scholar Rock is proud to support grants and sponsorships from p … programs must still meet the same high standards as accredited ones. We accept grant requests for programs that provide meaningful education within our therapeutic areas of interest. Sponsorships Scholar Rock provides sponsorship support for events, projects, or programs that offer tangible business benefits and are intended to educate patients, caregivers, scientists, or healthcare professionals. Examples of sponsorship requests may include corporate memberships, advertisin … osium slots. Areas of Interest Neuromuscular disease Spinal muscular atrophy To submit a request for grant support or sponsorships, please send an email to [email protected] Investigator-Initiated Studies At Scholar Rock, we are dedicated to expanding scientific knowledge and improving patient care through meaningful connectivity with the research community. An investigator-initiated study (IIS) is research led by an independent third-party investigator or institution th … ss The submission process consists of two key steps: Step 1: Concept Submission Submit a brief study concept that includes: A concise study rationale and design A description of the type of support requested (e.g., funding, drug supply) An estimated overall budget (if funding is requested) Step 2: Full Proposal If the concept is selected for furt
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Our Science | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our … diseases. Watch Video Harnessing the life-changing potential of TGFβ biology We apply this approach across growth factors in the TGFβ (transforming growth factor beta) superfamily, which are proteins that play fundamental roles in many serious diseases. Our proprietary platform enables development of therapeutic antibodies that are designed to selectively regulate the activation of specific growth factors, while avoiding interference with unintended, related growth factors an … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Platform | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Co … iseases with high unmet need while limiting unintended side effects. See how we apply this in practice Footer Scholar Rock, Inc. 301 Binney Street, 3rd Floor Cambridge, MA 02142 Phone: 857.259.3860 [email protected] LinkedIn X, formally Twitter SCHOLAR ROCK and the S logo are trademarks of Scholar Rock, Inc. © 2026 All Rights Reserved Community Guidelines Expanded Access Privacy Policy Terms of Use We are Scholar Rock. A biopharmaceutical company dedicated to discovering … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Management Team | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock Careers | Levels.fyi Download App Change Login Sign Up All Data By Location By Company By Title Salary Calculator Chart Visualizations Verified Salaries Internships H-1B Salaries Negotiation Support Compare Benefits Who's Hiring 2025 Pay Report Top Paying Companies Integrate Blog Press Google Software Engineer Product Manager New York City Area Data Scientist Explore By Different Titles Levels FYI Logo Salaries 📂 All Data 🌎 By Location 🏢 By Company 🖋 By Title 🏭️ By Industry 📍 Salary Heatmap 📈 Chart Visualizations 🗺️ Atlas 🔥 Real-time Percentiles 🎓 Internships 🛂 H-1 … te is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply. Featured Jobs No featured jobs found for Scholar Rock Related Companies Uber Dropbox Databricks SoFi Intuit See all companies ➜ Other Resources End of Year Pay Report Calculate Total Comp Featured Jobs No featured jobs found for Scholar Rock Related Companies Uber Dropbox Databricks SoFi Intuit See all companies ➜ Other Resources End of Year Pay Report Calculate Total Comp Request an AI sum
Director, Upstream MSAT & Process Development in Cambridge at Scholar Rock | Apply now! – StudySmarter – Talents Everything for your career Find a job Director, Upstream MSAT & Process Development in Cambridge Apply Now Apply Now Job Board Companies Scholar Rock Director, Upstream MSAT & Process Development Director, Upstream MSAT & Process Development in Cambridge Cambridge Full-Time 120000 - 180000 $ / year (est.) No home office possible Apply Now Apply Now S At a Glance Tasks: Lead biologics upstream MSAT and process development for innovative therapies. Company: Scholar Roc … to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. We are seeking an experienced and strategic Director of Upstream MSAT and Process Development within Technical Operations (CMC) to lead our biologics upstream MSAT and process development function across early-stage, late-stage, and commercial pr … haring your experiences on platforms like ResearchGate to enhance visibility. ✨ Apply Directly On Company Websites When you find a company you're excited about, like Scholar Rock, go directly to their careers page and apply. Many biotech firms prefer to source candidates from their own sites. Also, it shows initiative and that you’re serious about joining the team! We think you need these skills to ace Director, Upstream MSAT & Process Development in Cambridge Upstrea … ication Skills Decision-Making Capability Project Management Some tips for your application 🫡 Showcase Your Scientific Skills: When applying for a full-time role in biotechnology, it's crucial to highlight your relevant scientific skills and experience. Include specific techniques or technologies you've worked with, like CRISPR or mass spectrometry, in your CV. This way, we can see that you have the hands-on experience necessary for the position at Scholar Rock. Tail … ring cross-functional team initiatives. This can make a huge difference in your application quality. How to prepare for a job interview at Scholar Rock ✨ Showcase Your Technical Know-How In biotechnology, it's crucial to demonstrate a strong grasp of relevant techniques and tools—so be prepared to discuss the lab methods you've used or an
Deborah Meshulam | School of Engineering Skip to main content Skip to search School of Engineering Information For Students Faculty & Staff Alumni Industry Partners Find Faculty Apply Give Open search Close search Open menu Close menu About Dean Kyongbum Lee Undergraduate and Graduate Deans Mission & Vision Diversity, Equity, Inclusion, and Justice Leadership Team Employment Opportunities Donor Report Contact Us Undergraduate Degrees & Majors Second Majors Minors Fifth-Year Master's Degree Program Experiential Learning Computer Programming Placement Exam Study Abroad ABET Enro … ation (Co-Op) Program Certificate Programs Part-time Study Continuing Education Scholarship Opportunities Professional Development Admitted Students Departments & Centers Biomedical Engineering Chemical and Biological Engineering Civil and Environmental Engineering Computer Science Electrical and Computer Engineering Mechanical Engineering Tufts Gordon Institute Center for Applied Brain and Cognitive Sciences Center for Engineering Education and Outreach (CEEO) Center for … ormation For Students Faculty & Staff Alumni Industry Partners Find Faculty Apply Give Breadcrumb Home Engineering Commencement Deborah Meshulam Deborah Meshulam Deborah Meshulam has served as Senior Vice President of Technical Operations at Scholar Rock since August 2022. She is a biotechnology industry veteran and has nearly 40 years of experience, working at companies in their initial, start-up stage. In her current position, Meshulam is responsible for all Technical O
What is Brief History of Scholar Rock Company? – businessmodelcanvastemplate.com Skip to content Framework Templates Blogs Search Cart 0 / $0.00 What Is the Brief History of Scholar Rock Company? July 12, 2025 SCHOLAR ROCK BUNDLE Get the Full Package: 5 Forces $15 $10 BCG Matrix $15 $10 Canvas $15 $10 Marketing Mix $15 $10 PESTLE $15 $10 SWOT Analysis $15 $10 TOTAL: ADD TO CART What's the Story Behind Scholar Rock? Scholar Rock Company, a biotech company, is making waves in the pharmaceutical world with its innovative approach to drug development. Founded in 2012 in Cambridge, Massachuse … ion in cash, cash equivalents, and marketable securities. This was projected to fund operations into the second half of 2025. By the end of 2024, this increased to approximately $437.3 million, expected to fund operations into the fourth quarter of 2026. Strategic Growth and Clinical Programs Scholar Rock's strategic growth efforts were focused on translating scientific discoveries into clinical programs. These efforts demonstrated the potential of their selective myostatin i … motor function for SMA patients. January 2025 Submission of a Biologics License Application (BLA) to the U.S. FDA for apitegromab. Q1 2025 Submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for apitegromab. February 2025 Positive Phase 2 EMBRAZE trial results, showing statistically significant preservation of lean mass with apitegromab during tirzepatide-induced weight loss. September 22, 2025 Prescription Drug User Fee Act (PDUFA … (PDUFA) target action date for the BLA of apitegromab. Q3 2025 Anticipated IND application for SRK-439, a myostatin inhibitor for cardiometabolic indications. The company's innovation is centered around its proprietary platform focused on modulating growth factors, particularly the TGF-beta superfamily, to treat muscle diseases. This approach allows Scholar Rock to target specific disease pathways with high precision. The company's work demonstrates its commitment to advanci … upsized $345 million public offering. January 2025 Submitted Biologics License Application (BLA) for apitegromab to the U.S. FDA. February 27, 2025 Reported full-year 2024 financial results, ending 2024 with approximately $437 million in cash, cash equivalents, and marketable securities. March 2025 FDA accepted Scholar Rock's BLA for apitegromab
Careers | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Com … area where we cultivate potential. Scholar Rock offers unique opportunities to apply your expertise and insights within a focused, commercial-ready environment, so you can continue growing professionally in both knowledge and skills. “Every voice counts at Scholar Rock; we look beyond degrees and experience to uncover ways for employees to grow and contribute to the innovation conversation.” Matt Larson Senior Director, Talent Acquisition Benefits and Perks We’ve got you cov … ostings on various job boards. For your safety, please verify a role exists and apply directly on our website. You can trust job listings from our applicant tracking system, Lever. Scholar Rock will only email you from an official @scholarrock.com email account. Our applicant tracking system, Lever, may also send some confirmation or notification emails, but you should not expect messages from any other sources. If you have seen what you believe is a fake job posting or have … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock - Vice President, Commercial Legal Counsel Vice President, Commercial Legal Counsel Cambridge, MA G&A – Legal / Full-Time / On-site apply for this job Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. O … ment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @Sch … nd are committed to creating an inclusive environment for all employees . apply for this job Scholar Rock Home Page Jobs powered by
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Cure SMA - Today, Scholar Rock announced that the U.S.... Facebook Log In Cure SMA's Post Cure SMA Verified account September 23, 2025 · Shared with Public Today, Scholar Rock announced that the U.S. Food and Drug Administration (FDA) has delayed the approval with a Complete Response Letter (CRL) for the apitegromab Biologics License Application (BLA) for the treatment of people living with spinal muscular atrophy (SMA). While this is disappointing news, the issues identified by the regulator appear to be due to an unrelated manufacturing plant issue rather than a problem with the clinica
Careers | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Com … area where we cultivate potential. Scholar Rock offers unique opportunities to apply your expertise and insights within a focused, commercial-ready environment, so you can continue growing professionally in both knowledge and skills. “Every voice counts at Scholar Rock; we look beyond degrees and experience to uncover ways for employees to grow and contribute to the innovation conversation.” Matt Larson Senior Director, Talent Acquisition Benefits and Perks We’ve got you cov … ostings on various job boards. For your safety, please verify a role exists and apply directly on our website. You can trust job listings from our applicant tracking system, Lever. Scholar Rock will only email you from an official @scholarrock.com email account. Our applicant tracking system, Lever, may also send some confirmation or notification emails, but you should not expect messages from any other sources. If you have seen what you believe is a fake job posting or have … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
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Scholar Rock resubmits apitegromab BLA for SMA | SRRK 8-K Filing --> STOCK TITAN Login Sign up Login Sign up 0 HOME --> NEWS FEED Stock News Live Stock News Today Trending News AI news FDA Approvals Clinical Trials Crypto News Merger & Acquisitions Earnings Offerings IPO News Stock Splits Top News - Gainers Top News - Losers SEC FILINGS SEC Filings Live SEC Filings Today Form 4 - Insider Trading 8-K - Material Events 10-K - Annual Reports 10-Q - Quarterly Reports DEF 14A - Proxy Statements S-1 - IPO Registration S-3 - Shelf Registration STOCKS All Stock Themes AI Stocks Crypto Stocks Oil & Gas … filed a current report describing that it has resubmitted its Biologics License Application (BLA) to the FDA for apitegromab, a muscle-targeted therapy for children and adults with spinal muscular atrophy (SMA). The company anticipates FDA acceptance of the resubmitted BLA within 30 days and a review period of up to six months, with a PDUFA action date expected in late September 2026. The resubmission also adds a second U.S. fill-finish facility alongside Catalent Indiana to … al demand. In Europe, the EMA review of the apitegromab Marketing Authorisation Application is progressing, with a decision anticipated around mid-2026. Positive Apitegromab BLA resubmission and clear FDA review timeline re-establish a regulatory path, with anticipated U.S. PDUFA action in late September 2026 and an EMA decision expected mid-2026 for this late-stage SMA therapy. Negative None. Insights Biopharma regulatory analyst positive Resubmitted apitegromab BLA moves SM … te September 2026. In parallel, the EMA decision on the Marketing Authorisation Application is anticipated around mid-2026, so subsequent disclosures around these milestones will shape how the program advances. 8-K Event Classification 3 items: 7.01, 8.01, 9.01 3 items Item 7.01 Regulation FD Disclosure Disclosure Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance. Item 8.01 Other Events Other Voluntary disclos … sitive FDA Type C meeting on adding second facility Key Terms Biologics License Application (BLA), Complete Response Letter (CRL), Prescription Drug User Fee Act (PDUFA), Fast Track, +2 more 6 terms Biologics License Application (BLA) regulatory "announced it has resubmitted the Biologics License Application (BLA) for apitegromab" A biologics lic
Careers | Scholar Rock Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Com … area where we cultivate potential. Scholar Rock offers unique opportunities to apply your expertise and insights within a focused, commercial-ready environment, so you can continue growing professionally in both knowledge and skills. “Every voice counts at Scholar Rock; we look beyond degrees and experience to uncover ways for employees to grow and contribute to the innovation conversation.” Matt Larson Senior Director, Talent Acquisition Benefits and Perks We’ve got you cov … ostings on various job boards. For your safety, please verify a role exists and apply directly on our website. You can trust job listings from our applicant tracking system, Lever. Scholar Rock will only email you from an official @scholarrock.com email account. Our applicant tracking system, Lever, may also send some confirmation or notification emails, but you should not expect messages from any other sources. If you have seen what you believe is a fake job posting or have … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
EX-99.1 2 srrk-20260303xex99d1.htm EX-99.1 Exhibit 99.1 Scholar Rock Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Business Highlights ● Apitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) ● FDA completed constructive meeting with Catalent Indiana, LLC (part of Novo Nordisk), with discussion of remediation progress and no additional corrective actions requested by FDA ● Scholar Rock plans to resubmit BLA … DA reinspection of Catalent Indiana ● Apitegromab Marketing Authorisation Application (MAA) review ongoing, with EMA decision anticipated in mid-2026; European launch expected in H2 2026, starting with Germany ● Secured new debt facility, providing up to $550 million in non-dilutive capital to support commercialization of apitegromab and strategic advancement of key pipeline programs ● Cash, cash equivalents, and marketable securities of $367.6 million as of … ry review ongoing. A decision by EMA on the apitegromab Marketing Authorisation Application (MAA) is expected in mid-2026. The European team continues to engage with key stakeholders on SMA disease awareness and education initiatives. The Company is planning for an apitegromab launch in Europe in the second half of 2026, beginning with Germany. ● Advancing key activities at second fill-finish facility. Technology transfer continues at a second U.S.-based fill-finish fac … turing runs planned through the second quarter of 2026. Scholar Rock expects to submit a supplemental BLA (sBLA) for this fill-finish facility later in 2026. ● Phase 2 OPAL clinical trial ongoing . Enrollment and patient dosing continue in the Phase 2 OPAL study (NCT07047144). The trial is designed to evaluate apitegromab in infants and toddlers with SMA under two years of age who have received an approved SMN1-targeted gene therapy or who are receiving ongoing treatmen … oximately 30,000 individuals across the U.S. and Europe. The IND application is cleared, and the Company continues to anticipate the initiation of a Phase 2 randomized, double-blind, placebo-controlled trial, called FORGE, in mid-2026. SRK-439 SRK-439 is a novel, investigational, subcutaneously administered myostatin inhibitor that
Scholar Rock (SRRK) | Trefis Scholar Rock (SRRK) | Trefis | Trefis All Data About Our Story Management Team Investors and Advisors Careers Contact Us Try Trefis Sign In × Try Trefis Sign In All Data About Our Story Management Team Investors and Advisors Careers Contact Us Try Trefis Sign In Tearsheet SRRK Home Investment Highlights Valuation & Metrics Price Chart Why The Stock Moved Return vs. Risk About SRRK Interactive Breakdown Better Bets vs. SRRK Latest Trefis Analyses Trade Ideas Recent Active Movers More From Trefis Peer Comparisons - Financials - Growth & Marg … ike Roche and Biogen. Show less. SRRK in ETFs Weight = SRRK's share of each fund VTI 0.01% ITOT 0.01% IWM 0.13% VB 0.00% XBI 1.2% IBB 0.39% IWO 0.21% VTWO 0.12% +8 more covered ETFs Valuation & Metrics Valuation Consensus Key Metrics Op. Metrics FYE: 12/31 Forward FYE Now Historical (CYE & TTM) 2027 2026 6/27/26 2025 2024 2023 2022 Share Price $54.76 $44.05 $43.22 $18.80 $9.05 Mkt Cap ($ Bil) 7.0 5.3 4.7 1.7 0.7 + Debt ($ Bil) … latory progress for apitegromab. Scholar Rock resubmitted the Biologics License Application (BLA) for apitegromab to the FDA on March 31, 2026. This was followed by the FDA's acceptance of the BLA on May 6, 2026, assigning a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2026, for its lead spinal muscular atrophy (SMA) therapy. This BLA notably included two U.S. fill-finish facilities, addressing prior manufacturing concerns and clarifying the regulatory … et At-the-Market (ATM) equity proceeds. This increased liquidity is expected to fund the company's operations into mid-2027, providing a more secure financial foundation for ongoing development and commercialization efforts. Show more Updated on 6/26/2026 Scholar Rock (SRRK) stock has gained about 25% since 2/28/2026 because of the following key factors: 1. Significant regulatory progress for apitegromab. Scholar Rock resubmitted the Biologics License Application (BLA) for ap … et At-the-Market (ATM) equity proceeds. This increased liquidity is expected to fund the company's operations into mid-2027, providing a more secure financial foundation for ongoing development and commercialization efforts. 3. Advancement and diversification of the clinical pipeline. Beyond SMA, Scholar Rock made notable progress in its broader
SCHOLAR ROCK HOLDING CORP_SEPTEMBER 30, 2025 0001727196 --12-31 2025 Q3 false 1 http://fasb.org/us-gaap/2025#SecuredOvernightFinancingRateSofrMember 0001727196 us-gaap:CommonStockMember 2025-01-01 2025-03-31 0001727196 us-gaap:CommonStockMember 2024-07-01 2024-09-30 0001727196 us-gaap:CommonStockMember 2024-04-01 2024-06-30 0001727196 us-gaap:CommonStockMember 2025-07-01 2025-09-30 0001727196 us-gaap:OverAllotmentOptionMember 2024-10-01 2024-10-31 0001727196 srrk:UnderwritingAgreementMember 2024-10-01 2024-10-31 0001727196 srrk:AggregateMember srrk:AtMarketOfferingMember 2022-11-01 2 … 12 months (or for such shorter period that the registrant was required to submit such files).    Yes    ☒     No   ☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller re … y achieved its primary endpoint. The Company submitted a U.S. Biologics License Application (“BLA”) to the FDA in January 2025 and the BLA was granted priority review designation. In September 2025, the Company received a Complete Response Letter (“CRL”) from the FDA related to observations identified during a routine general site inspection of a third-party fill-finish facility. The facility was issued a Form 483 by the FDA in July 2025 and the inspec … ency (“EMA”) and received validation of its marketing authorisation application (“MAA”) for apitegromab for the treatment of SMA. The FDA granted Fast Track designation, Rare Pediatric Disease designation and Orphan Drug designation to apitegromab for the treatment of SMA in May 2021, August 2020 and March 2018, respectively. The EMA granted Priority Medicines (“PRIME”) designation in March 2021 and the European Commission (“EC” … ting neuromuscular disorders and in September 2025, an investigational new drug application was cleared by the FDA. The Company plans to initiate dosing of SRK-439 in healthy volunteers in the fourth quarter of 2025. The Company’s product candidate, SRK-181, a highly selective inhibitor of the activation of latent TGFβ1, is being devel
How To Invest In Scholar Rock Holding Corp Stock - SRRK Share Price Today & News | Stash |
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The purpose of this expanded access program (EAP) is to provide access to apitegromab for eligible patients with spinal muscular atrophy (SMA) prior to approval by the local regulatory agency . A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.
SRRK SEC Filings - Scholar Rock Holding 10-K, 10-Q, 8-K Forms --> STOCK TITAN Login Sign up Login Sign up 0 HOME --> NEWS FEED Stock News Live Stock News Today Trending News AI news FDA Approvals Clinical Trials Crypto News Merger & Acquisitions Earnings Offerings IPO News Stock Splits Top News - Gainers Top News - Losers SEC FILINGS SEC Filings Live SEC Filings Today Form 4 - Insider Trading 8-K - Material Events 10-K - Annual Reports 10-Q - Quarterly Reports DEF 14A - Proxy Statements S-1 - IPO Registration S-3 - Shelf Registration STOCKS All Stock Themes AI Stocks Crypto Stocks Oil & Gas De … est and become fully exercisable on the earlier of the first anniversary of the grant date or the next Annual Meeting, also subject to continued service. After the RSU grant, his direct common stock position is 30,909 shares, including 24,070 shares of common stock and 6,839 RSUs. Rhea-AI Impact Rhea-AI Sentiment End-of-Day -- % Tags insider - 06/08/2026 04:55 PM Filing Scholar Rock (SRRK) director Joshua Reed receives RSU and option grants Rhea-AI Summary Scholar Rock Holdin … ice of $45.33 per share, vesting on the earlier of the first anniversary of the grant date or the next annual meeting, again subject to continued service. Following these awards, Reed directly holds or has rights to 22,571 common shares and RSUs in total, plus 4,310 stock options, indicating a routine, compensation-related increase in his equity stake rather than any open-market buying or selling. Rhea-AI Impact Rhea-AI Sentiment End-of-Day -- % Tags insider - 06/08/2026 04:5 … the company’s next Annual Meeting, subject to continued service. Following this grant, he holds 21,896 common-share interests, including these RSUs. He was also granted stock options for 4,310 shares of common stock at an exercise price of $45.33 per share, which will vest and become fully exercisable on the earlier of the first anniversary of the grant date or the next Annual Meeting, again contingent on continued service. Rhea-AI Impact Rhea-AI Sentiment End-of-Day -- % Tag … holdings to 110,871 common shares plus 6,839 RSUs. She also received an option grant for 4,310 shares of common stock at an exercise price of $45.33 per share, expiring on June 4, 2036, which will vest on the earlier of the first anniversary of grant or the company’s next annual meeting, subject to continued service. Separately, 2,345,711 common
Scholar Rock Presents SMA Research Updates at Upcoming Conferences | Scholar Rock posted on the topic | LinkedIn LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings . Accept Reject Agree & Join LinkedIn By clicking Continue to join or sign i
Scholar Rock Highlights 2026 Strategic Priorities - FSHD Society only used for Pushy, deprecated --> English English العربية Español de México Français du Canada 简体中文 Events Blog BetterLife Living with FSHD Understanding FSHD Diagnosis Early-onset FSHD Genetic Testing Symptoms FSHD University Physical Health Wellness Glossary of Scientific Terms Patient Library Genetic Cause Managing FSHD BetterLife FSHD Finding Care FSHD Navigator Newly Diagnosed with FSHD? FSHD Clinical Care Additional Resources Adaptive Equipment Coordinating Care Caregiver Self-care Financial/Legal Resources Family Plannin … or Researchers International Research Congress BetterLife FSHD Research Gateway Apply for a Grant For Clinicians Continuing Education FSHD Masterclass Therapeutic Accelerator Project Mercury Global Innovation Hub About Us About the FSHD Society History Our Mission Our Impact Research We Have Funded Our Team Our Partners Financials Media Center Brand Guidelines News & Media Blog FSHD Research FSHD Society News Fundraising & Events General Living with FSHD Health and M … 6, Originally posted to Business Wire Highlights: Apitegromab Biologics License Application (BLA) resubmission and U.S. launch, following FDA approval, are anticipated in 2026 for the treatment of children and adults with spinal muscular atrophy (SMA) FDA has scheduled meeting with Catalent Indiana, LLC (part of Novo Nordisk) in early 2026 to discuss progress of remediation efforts Apitegromab Investigational New Drug (IND) application cleared for facioscapulohumeral muscular … mpany continues to expect a decision on its apitegromab Marketing Authorisation Application (MAA) in mid-2026. U.S. and European launch preparations ongoing. U.S. and European customer-facing teams are in the field and continue to engage with key stakeholders on SMA disease awareness and education initiatives, including the unmet need in SMA and the importance of targeting muscle. Second U.S. fill-finish facility commercial capacity reserved beginning Q1 2026. Scholar Rock is … cts and has a strong regulatory inspection track record. The Company expects to submit a supplemental BLA (sBLA) with this second site later in 2026. Develop apitegromab for patients with SMA (<2 years old) and for additional rare, severe neuromuscular diseases As part of Scholar Rock’s long-term strategy, the Company is developing apit
Scholar Rock Receives News on Biologics License Application (BLA) for Apitegromab from the U.S. FDA Skip to content Shop Latest News About Us Our Story Mission & Vision Our History Our Team & Partners Leadership Local Chapters National Partners Support & Resources Contact Us Community Support Annual Reports & Financials Publications Media SMA About SMA Overview Describing SMA Genetics Testing & Diagnosis Newborn Screening Living with SMA Overview Newly Diagnosed Infants & Children Teens & Adults Traveling with SMA Carriers of SMA Research Study Opportunities A … son Type A meeting with the FDA on November 12 to discuss the Biologics License Application (BLA) for apitegromab, a potential treatment for children and adults with SMA. Cure SMA was present and active at this FDA meeting to represent our community to ensure that the patient voice and the patient need were heard and factored into decisions. In particular stressing the urgency needed to address unmet needs across the entire age spectrum in SMA. The meeting was constructive, w
Scholar Rock Reports Apitegromab Meets Primary Endpoint in Phase 3 SAPPHIRE Study in Patients with Spinal Muscular Atrophy (SMA) | Scholar Rock, Inc. | Mo Qatanani, PhD LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings . Accept Reject Agre
Management Team | Scholar Rock Skip to primary navigation Skip to main content Skip to primary sidebar Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Scholar Rock Holding Corp's Chief Scientific Officer Sells Shares — TradingView News Search Products Community Markets Brokers More EN Get started News / TradingView / Scholar Rock Holding Corp's Chief Scientific Officer Sells Shares Scholar Rock Holding Corp's Chief Scientific Officer Sells Shares Less than 1 min read SRRK Reporter Name Qatanani Mo Relationship CHIEF SCIENTIFIC OFFICER, 10% Owner Type Sell Amount $6,169,788 SEC Filing Form 4 Mo Qatanani, the Chief Scientific Officer and a 10% owner of Scholar Rock Holding Corp, sold 136,462 shares of common stock on December 4,
Scholar Rock Reports Apitegromab Meets Primary Endpoint in Phase 3 SAPPHIRE Study in Patients with Spinal Muscular Atrophy (SMA) | Scholar Rock, Inc. | Scholar Rock | 39 comments LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at any time in your settings . Accept R
false 0001727196 0001727196 2025-04-26 2025-04-26 iso4217:USD xbrli:shares iso4217:USD xbrli:shares       UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549     FORM 8-K     CURRENT REPORT   Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934   Date of Report (Date of earliest event Reported): April 28, 2025 ( April 26, 2025 )   Scholar Rock Holding Corporation (Exact Name of Registrant as Specified in Charter)   Delaware 001-38501 82-3750435 (State or Other Jurisdiction of Incorporation) (Commission … ”) to purchase a number shares of the Company’s common stock with a grant date fair value (assuming a price per share equal to the volume weighted average price of the Company’s common stock on the Nasdaq Global Market for the four trading days immediately preceding the date of grant) (the “Option Grant Date Fair Value”) equal to $7.5 million (the “Hallal Stock Option Award”). The Hallal Stock Option Award will vest with respect to 25 … respect to 25% of the shares of common stock underlying the Hallal Stock Option Award on the first anniversary of the Transition Date (the “Hallal Vesting Commencement Date”), and the remaining 75% of the shares of common stock underlying the Hallal Stock Option Award shall vest in 12 equal quarterly installments following the Hallal Vesting Commencement Date, subject to Mr. Hallal’s continuing service at the Company through the applicable vesting date. The … ice at the Company through the applicable vesting date. The Hallal Stock Option Award will be subject to all terms and conditions and other provisions set forth in the Stock Option Plan and form of stock option agreement thereunder.   Additionally, Mr. Hallal was granted restricted stock units (“RSUs”) for 250,000 shares of the Company’s common stock, which shall vest annually over four years, subject to Mr. Hallal’s continuing service at the Comp … rvice at the Company through the applicable vesting date (the “Hallal RSU Award”). The Hallal RSU Award will be subject to all terms and conditions and other provisions set forth in the Stock Option Plan and form of restricted stock unit agreement thereunder.   Mr. Hallal was also granted performance based restricted stock units
We are excited to introduce David Hallal, Chief Executive Officer and Chairman at Scholar Rock. David has a proven track record of building global businesses. At Scholar Rock, he will leverage this… | Scholar Rock LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your choices at a
David Hallal Skip to primary navigation Skip to main content Skip to footer Skip to investors navigation Scholar Rock Discovery and Development of Innovative Medicines Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact Patients & Families Patients & Families Areas of Focus Spinal Muscular Atrophy Patient Stories Clinical Trials Resources Expanded Access Learn about our commitment to creating possibilities for those living with serious disease. Patients & Families Our Company Our C … Coverage Investor FAQs Contact IR or Media Careers Newsroom Contact Us For HCPs Grant and Sponsorships Investigator-Initiated Studies Expanded Access Additional Resources and Information Contact You are now leaving the Scholar Rock website. This external link is provided for your convenience. Scholar Rock is not responsible for content on external websites. Continue Cancel
Proud to have served Scholar Rock as Chairman of the Board since 2017. A privilege to have recruited Jay Backstrom to lead Scholar Rock in 2022 and work so closely together for nearly 3 years.… | David Hallal | 54 comments LinkedIn respects your privacy LinkedIn and 3rd parties use essential and non-essential cookies to provide, secure, analyze and improve our Services, and to show you relevant ads (including professional and job ads ) on and off LinkedIn. Learn more in our Cookie Policy . Select Accept to consent or Reject to decline non-essential cookies for this use. You can update your cho
Scholar Rock, Inc. - Drug pipelines, Patents, Clinical trials - Synapse Products Data Feature Plans Request Demo Sign Up for Free Last update 12 May 2026 Scholar Rock, Inc. Education | 2012 | Massachusetts, United States | 100-250 | NASDAQ: SRRK | scholarrock.com Education | 2012 | Massachusetts, United States | 100-250 | NASDAQ: SRRK | scholarrock.com Last update 12 May 2026 Overview Pipeline Deal Translational Medicine Profit Grant & Funding(NIH) Investment Financing Overview Tags Other Diseases Nervous System Diseases Neoplasms Monoclonal antibody Disease domain score A glimpse into the … While much of the published work has focused on mAbs, the principles appear to apply to any therapeutic protein, although mAbs clearly have some distinctive features. In this review, we first discuss chemical degradation reactions. This is followed by a section on physical instability issues. Then, more specific topics are addressed: instability induced by interactions with interfaces, predictive methods for physical stability and interplay between chemical and physical inst … amed company told its investors that the FDA’s reasoning for rejecting its drug application was unclear. Once the agency made the CRLs public, however, Baral was able to see that the agency had been clear and consistent across its various communications with the company. The second CRL for Replimune’s RP1 also pointed to differing perspectives from the FDA and the company regarding previous agreements. While Replimune CEO Sushil Patel contended after the product’s first rejec … illed syringe, and had a PDUFA date in April. Scholar Rock has also refiled its application for apitegromab and has been granted an action date in September. Aside from manufacturing issues, insufficient clinical data also emerged as a key stumbling block for many drug sponsors, with Jefferies’ analysis showing that 27% of CRLs noted the need for more data. These requests can range from additional subgroup or pharmacodynamic analyses using existing data to the need for anothe … oducts for Human Use (CHMP) opinion for the apitegromab Marketing Authorisation Application (MAA) is anticipated near mid-2026. The Scholar Rock team in Europe continues to engage with key stakeholders on SMA disease awareness and education initiatives, including at the 5 th International Scientific Congress on SMA, which was held March 11 – 14,
Scholar Rock Strategy and Business Model Skip to content Skip content FIND YOUR CONSULTANT JOIN OUR COMMUNITY Services Strategy Operations Organization Marketing Finance Sales Artificial Intelligence (AI) Interim/Fractional Executives Enterprise Resource Planning (ERP) Associate-level Support Board Recruiting Pro bono Industries Resources Locations Insights Podcast Blog Books by members Umbrex Presents PowerPoint Templates About What we do Consultant directory Press Contact For consultants Join our Community How to start your own practice Events Resources Podcast Members’ forum Umbrex Co … ur own practice Events Resources Podcast Members’ forum Umbrex Consulting Fellowship Consultant directory Services Strategy Operations Organization Marketing Finance Sales Artificial Intelligence (AI) Interim/Fractional Executives Enterprise Resource Planning (ERP) Associate-level Support Board Recruiting Pro bono Industries Resources Locations Insights Podcast Blog Books by members Umbrex Presents PowerPoint Templates About What we do Consultant directory Press Contact … ur own practice Events Resources Podcast Members’ forum Umbrex Consulting Fellowship Consultant directory FIND YOUR CONSULTANT JOIN OUR COMMUNITY Services Strategy Operations Organization Marketing Finance Sales Artificial Intelligence (AI) Interim/Fractional Executives Enterprise Resource Planning (ERP) Associate-level Support Board Recruiting Pro bono Industries Resources Locations Insights Podcast Blog Books by members Umbrex Presents PowerPoint Templates About What … ur own practice Events Resources Podcast Members’ forum Umbrex Consulting Fellowship Consultant directory Services Strategy Operations Organization Marketing Finance Sales Artificial Intelligence (AI) Interim/Fractional Executives Enterprise Resource Planning (ERP) Associate-level Support Board Recruiting Pro bono Industries Resources Locations Insights Podcast Blog Books by members Umbrex Presents PowerPoint Templates About What we do Consultant directory Press Contact … ur own practice Events Resources Podcast Members’ forum Umbrex Consulting Fellowship Consultant directory Company Profiles > Scholar Rock Strategy and Business Model Scholar Rock Strategy and Business Model Executive Overview Scholar Rock is a Cambridge, Massachusetts-based clinical-stage biopharmaceutical company founded in 2012 and foc
Scholar Rock to Present at Upcoming March 2026 Investor Conferences - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Pre … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search Press Releases Scholar Rock to Present at Upcoming March 2026 Investor Conferences February 18, 2026 | 2 min read Twitter LinkedIn Facebook Email Print CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to dramatically improving the lives of children and adults w … ment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock o … bsp; 2 min read · Tristan Manalac Podcast AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more June 24, 2026 · 1 min read · Jef Akst China BIO 2026: US needs to dodge China’s ‘inescapable dependencies’ to protect biotech June 24, 2026 · 2 min read · Annalee Armstrong BioSpace at BIO to find out" href="https://www.biospace.com/drug-development/can-adcs-be-kin … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin
Scholar Rock to Report Third Quarter 2025 Financial Results on November 14, 2025 - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search Press Releases Scholar Rock to Report Third Quarter 2025 Financial Results on November 14, 2025 October 24, 2025 | 2 min read Twitter LinkedIn Facebook Email Print CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK) today announced that it will report third quarter 2025 financial results on Friday, November 1 … ment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock o … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin
Much Maligned Manufacturing Site Trips Up Scholar Rock’s Spinal Muscular Atrophy Drug - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy C … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search News FDA Much Maligned Manufacturing Site Trips Up Scholar Rock’s Spinal Muscular Atrophy Drug September 23, 2025 | 2 min read | Tristan Manalac Twitter LinkedIn Facebook Email Print iStock, cagkansayin In its rejection letter, the FDA flagged problems at a third-party fill-finish site owned b … hat it could “mitigate further concerns” surrounding the rejection. To back its application for apitegromab, Scholar Rock filed data from the Phase III SAPPHIRE study, which in October 2024 demonstrated a significant improvement in motor function. Benefits were apparent as early as 8 weeks and further improved through 52 weeks of follow-up, the company said at the time. Last month, STAT News made public a report of the FDA’s investigation at the same Catalent facility, docume … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin
Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA) - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search Press Releases Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA) March 31, 2026 | 9 min read Twitter LinkedIn Facebook Email Print Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and … usculoskeletal health, today announced it has resubmitted the Biologics License Application (BLA) for apitegromab for the treatment of children and adults with SMA to the U.S. Food and Drug Administration (FDA). Apitegromab is the first and only muscle-targeted therapy to demonstrate statistically significant and clinically meaningful improvements in motor function in a pivotal Phase 3 clinical trial in patients with SMA receiving treatment with an SMN-targeted therapy. “Our … rope, the European Medicines Agency (EMA) review of the Marketing Authorisation Application (MAA) for apitegromab is progressing well, with a decision anticipated mid-2026. The FDA has granted Fast Track, Orphan Drug, Priority Review, and Rare Pediatric Disease designations to apitegromab for the treatment of SMA. The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) and Orphan Medicinal Product designations. Conference Call Information Scholar Rock will … ment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin
Goodwin Advises Scholar Rock with Its $550 Million Six-Year Credit Facility from Blue Owl Capital | News & Events | Goodwin Skip to main content Goodwin Expertise People Careers Legal Paralegal Science Advisor Global Operations Team Insights & Resources About Us Our Story The Goodwin Way Opportunity, Inclusion, and Belonging Pro Bono Firm Leadership Locations News & Events Alumni Press Release March 24, 2026 Goodwin Advises Scholar Rock with Its $550 Million Six-Year Credit Facility from Blue Owl Capital Professionals Yasin E. Akbari Shane Albright Sarah Ashfaq Barry Z. Bazian Heat
Recent Phase 1 DRAGON Data Show SRK-181 Continues to be Well Tolerated with Early Indications of Efficacy - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturing Deals Business Job Trends Cel … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search News Drug Development Recent Phase 1 DRAGON Data Show SRK-181 Continues to be Well Tolerated with Early Indications of Efficacy November 10, 2022 | 10 min read Twitter LinkedIn Facebook Email Print Scholar Rock today announced early data from its Phase 1 DRAGON proof-of-concept trial of SRK-181, a selectiv … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin
Scholar Rock Announces New Preclinical Data for SRK-439 Showing Significant Lean Mass Increase and Enhanced Fat Mass Loss with Metformin - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturin … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search Press Releases Scholar Rock Announces New Preclinical Data for SRK-439 Showing Significant Lean Mass Increase and Enhanced Fat Mass Loss with Metformin November 4, 2024 | 11 min read Twitter LinkedIn Facebook Email Print - Preclinical data show that SRK-439 increased lean mass and lowered fat mass gain in mice receiving … to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about our approach at ScholarRock.com and … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin
Scholar Rock Announces Presentation of New Preclinical Data Evaluating SRK-439 in Obesity at Keystone Symposia - BioSpace News Drug Development FDA Manufacturing Deals Business Job Trends Cell and Gene Therapy Cancer Opinions Press Releases All News & Releases Podcasts Events Jobs Companies Hotbeds More Reports Career Advice NextGen: Top Startups to Watch 40 Under 40 Best Places to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event SUBSCRIBE Menu SUBSCRIBE Show Search News Drug Development FDA Manufacturing Deals Business Job Trend … laces to Work Employer Resources Advertise Advertise Talent Solutions Post Jobs Submit a Press Release Submit an Event Search Query Submit Search Genetown Scholar Rock Announces Presentation of New Preclinical Data Evaluating SRK-439 in Obesity at Keystone Symposia January 25, 2024 | 7 min read Twitter LinkedIn Facebook Email Print Scholar Rock (NASDAQ: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular at … to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about our approach at ScholarRock.com and … bsp; 2 min read · Tristan Manalac Podcast AbbVie keeps M&A rolling, FDA’s reversal train chugs along, BIO 2026 dispatch, more June 24, 2026 · 1 min read · Jef Akst China BIO 2026: US needs to dodge China’s ‘inescapable dependencies’ to protect biotech June 24, 2026 · 2 min read · Annalee Armstrong BioSpace at BIO to find out" href="https://www.biospace.com/drug-development/can-adcs-be-kin … Policy RSS Feeds Advertise Employer Login Post Jobs Talent Solutions Advertise Submit a Press Release Submit an Event © 1985 - 2026 BioSpace.com. All rights reserved. twitter instagram facebook linkedin