Apitegromab remains on track to be the first and only muscle-targeted treatment for people living with Spinal Muscular Atrophy FDA to review BLA application under priority review, with a PDUFA date of September 22, 2025 Apitegromab Marketing Authorisation Application to the European Medicines Agency validated and under review Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted

Primary endpoint showed clinically meaningful improvement in patients with SMA receiving apitegromab as measured by gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) versus placebo (p=0.0192), with consistent outcomes across all major sub-groups including age, SMN-targeted background therapy, and age at initiation of SMN-targeted therapy Pre-specified secondary endpoint showed that 30.4% of patients receiving apitegromab had ≥ 3-point improvement in HFMSE versus 12.5% of patients on placebo (nominal p-value = 0.0156), despite all study patients receiving ongoing SMN-targeted background therapy In other pre-specified secondary endpoints, patients with SMA receiving apite

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 113,800 shares of its common stock to seven newly hired employees, consisting of inducement stock options to purchase an aggregate of 65,027 shares of common stock and inducement restricted stock units, covering an aggregate of 48,773 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth

H.C. Wainwright reiterated coverage of Scholar Rock with a rating of Buy and set a new price target of $50.00 from $40.00 previously

H.C. Wainwright reiterated coverage of Scholar Rock with a rating of Buy and set a new price target of $35.00 from $30.00 previously

Raymond James initiated coverage of Scholar Rock with a rating of Strong Buy and set a new price target of $30.00

4 - Scholar Rock Holding Corp (0001727196) (Issuer)

4 - Scholar Rock Holding Corp (0001727196) (Issuer)

4 - Scholar Rock Holding Corp (0001727196) (Issuer)

4 - Scholar Rock Holding Corp (0001727196) (Issuer)

4 - Scholar Rock Holding Corp (0001727196) (Issuer)

3 - Scholar Rock Holding Corp (0001727196) (Issuer)

8-K - Scholar Rock Holding Corp (0001727196) (Filer)

144 - Scholar Rock Holding Corp (0001727196) (Subject)

S-8 - Scholar Rock Holding Corp (0001727196) (Filer)

- Former Vice President and Global HR Head of Oncology and Pharma Development at Novartis brings extensive leadership experience focused on talent, culture, and diversity Scholar Rock (NASDAQ:SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced the appointment of Caryn Parlavecchio as Chief Human Resources Officer. She will join the executive team, bringing more than 20 years of experience as a senior leader and strategic executive in the biotechnology and pharmaceutical industries. This press release features multimedia. View the full release here: https://www.businesswire.co

Apitegromab remains on track to be the first and only muscle-targeted treatment for people living with Spinal Muscular Atrophy FDA to review BLA application under priority review, with a PDUFA date of September 22, 2025 Apitegromab Marketing Authorisation Application to the European Medicines Agency validated and under review Scholar Rock (NASDAQ:SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for neuromuscular diseases, cardiometabolic disorders, and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for apitegromab, an investigational muscle-targeted

Primary endpoint showed clinically meaningful improvement in patients with SMA receiving apitegromab as measured by gold standard Hammersmith Functional Motor Scale Expanded (HFMSE) versus placebo (p=0.0192), with consistent outcomes across all major sub-groups including age, SMN-targeted background therapy, and age at initiation of SMN-targeted therapy Pre-specified secondary endpoint showed that 30.4% of patients receiving apitegromab had ≥ 3-point improvement in HFMSE versus 12.5% of patients on placebo (nominal p-value = 0.0156), despite all study patients receiving ongoing SMN-targeted background therapy In other pre-specified secondary endpoints, patients with SMA receiving apite

Scholar Rock (NASDAQ:SRRK, the "Company")), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy, cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, today announced that the company granted inducement equity awards covering an aggregate of 113,800 shares of its common stock to seven newly hired employees, consisting of inducement stock options to purchase an aggregate of 65,027 shares of common stock and inducement restricted stock units, covering an aggregate of 48,773 shares of its common stock. The awards are subject to all terms and conditions and other provisions set forth

SC 13G/A - Scholar Rock Holding Corp (0001727196) (Subject)

SC 13G/A - Scholar Rock Holding Corp (0001727196) (Subject)

SC 13G/A - Scholar Rock Holding Corp (0001727196) (Subject)