Scholar Rock: Manufacturing Noise Obscures A Muscle-Targeted Franchise

Scholar Rock is positioned to launch apitegromab as the first muscle-targeted therapy for SMA, pending FDA approval by September 30, 2026. Manufacturing setbacks were production-based, not due to drug efficacy or safety; the alternate fill-finish facility mitigates approval risk but does not eliminate it. SAPPHIRE trial data support apitegromab's add-on value in SMA, showing statistically significant motor function gains over placebo for nonambulatory patients.

Seeking Alpha • Sep 7, 2026

Scholar Rock Receives FDA Fast Track Designation for Apitegromab Facioscapulohumeral Muscular Dystrophy (FSHD) Program as Participant Dosing Commences in Phase 2 FORGE Trial

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced that the FDA has granted Fast Track and Orphan Drug designations to apitegromab for the treatment of people living with FSHD. In addition, the Company announced that participant dosing is underway in the Phase 2 FORGE c.

Business Wire • Sep 2, 2026

Scholar Rock to Present at Upcoming Investor Conferences

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced that management will participate in the following investor conferences: Cantor 2026 Global Healthcare Conference: Scholar Rock is scheduled to participate in a fireside chat at 8:00 a.m. ET on Wednesday, September 9, 20.

Business Wire • Aug 27, 2026

Scholar Rock withdraws Europe filing for muscle weakness drug, plans resubmission

Scholar Rock said on Friday it withdrew its European application for the experimental spinal muscular atrophy ​drug and plans to resubmit it with a ‌different manufacturing site after issues at a Novo Nordisk-owned facility.

Reuters • Aug 21, 2026

Scholar Rock Provides Update on Global Apitegromab Regulatory Progress Across U.S., Europe, and Japan

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced it has successfully removed Catalent Indiana LLC (part of Novo Nordisk) as a commercial fill-finish facility from its apitegromab Biologics License Application (BLA) for the treatment of spinal muscular atrophy (SMA) in.

Business Wire • Aug 21, 2026

Scholar Rock Eyes Sept. 30 FDA Decision for SMA Drug Apitegromab

Scholar Rock NASDAQ: SRRK CEO David Hallal said the company is preparing for a September 30 FDA decision date for apitegromab, its investigational treatment for spinal muscular atrophy, or SMA, following a resubmitted biologics license application supported by an alternate fill-finish manufacturing facility.

MarketBeat • Aug 17, 2026

Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK; the “Company”) today announced that the company granted inducement equity awards covering an aggregate of 51,947 shares of its common stock to twelve newly hired employees, consisting of inducement stock options to purchase an aggregate of 14,889 shares of common stock and inducement restricted stock units, covering an aggregate of 37,058 shares of its common stock. The awards are subject to all terms and conditions and other provis.

Business Wire • Aug 14, 2026

Scholar Rock drops Catalent facility from marketing application for muscle weakness drug

Scholar Rock said on Friday it would remove Catalent's Indiana manufacturing facility from its application seeking ​FDA approval for a rare neuromuscular disease drug.

Reuters • Aug 7, 2026

Scholar Rock Q2 Earnings Call Highlights

Scholar Rock NASDAQ: SRRK said its resubmitted biologics license application for apitegromab remains on track for a U.S. Food and Drug Administration decision by its Sept. 30 PDUFA date, as the company prepares for a potential launch of the muscle-targeted treatment for spinal muscular atrophy, or SMA.

MarketBeat • Aug 7, 2026

Scholar Rock Announces FDA Review of Apitegromab Biologics License Application (BLA) for Spinal Muscular Atrophy (SMA) to Progress with Second Fill-Finish Facility; Approval Decision Anticipated by September 30, 2026 Action Date

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its world-leading platform in myostatin biology, today announced that the FDA review of the apitegromab Biologics License Application (BLA) for the treatment of children and adults with spinal muscular atrophy (SMA) is progressing with the Company's second fill-finish facility. The B.

Business Wire • Aug 7, 2026