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Scholar Rock

SRRK

Market cap $6.75B

55.41 USD

-0.26

0.47%

At close Updated Sep 11, 4:00 PM EDT

Pre-market

After hours

58.50

+3.09

5.58%

1 day

-0.47%

5 days

0.6%

1 month

6.41%

3 months

23.99%

6 months

28.32%

Year to date

29.46%

1 year

74.03%

5 years

42.44%

10 years

257.48%

About: Scholar Rock Holding Corp is a biopharmaceutical company focused on improving the lives of children and adults with Spinal Muscular Atrophy and other rare, severe, and debilitating neuromuscular diseases. Its pipeline candidates include apitegromab and a subcutaneous formulation of apitegromab. The clinical-stage pipeline also includes SRK-439, an investigational subcutaneously administered fully human anti-pro/latent myostatin antibody with high inhibitory potency and selectivity toward myostatin, being developed for the treatment of rare neuromuscular diseases. The company also maintains early-stage programs focused on therapies for rare, severe, and debilitating neuromuscular diseases.

Employees: 289

Healthcare Biotechnology

News

Positive

Neutral

Negative

Sentiment 3-Months

Positive 16.7%

Neutral 70.8%

Negative 12.5%

Why Scholar Rock Shares Are Trading Higher By Around 12%; Here Are 20 Stocks Moving Premarket

Shares of Scholar Rock Holding Corp (NASDAQ:SRRK) rose sharply in pre-market trading after the company announced the FDA approval of ISEMBYLD (apitegromab-mstn), the first and only muscle-targeted treatment for children and adults with Spinal Muscular Atrophy (SMA).

Why Scholar Rock Shares Are Trading Higher By Around 12%; Here Are 20 Stocks Moving Premarket

Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)

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 leading platform in myostatin biology, today announced that the FDA has approved ISEMBYLD (apitegromab-mstn) for the treatment of spinal muscular atrophy (SMA) in adults and children two years of age and older who are currently receiving a survival motor neuron 2 (SMN2)-targeted.

Scholar Rock Announces FDA Approval of ISEMBYLD™ (apitegromab-mstn), the First and Only Muscle-Targeted Treatment for Children and Adults with Spinal Muscular Atrophy (SMA)

US FDA approves Scholar Rock's muscle weakness drug

The U.S. Food ‌and Drug Administration on Friday ⁠approved Scholar Rock's therapy to treat a rare ‌genetic ⁠condition that causes muscle weakness.

US FDA approves Scholar Rock's muscle weakness drug

Scholar Rock Holding Corporation (SRRK) Presents at Citigroup's Biopharma Back to School Summit 2026 Transcript

Scholar Rock Holding Corporation (SRRK) Presents at Citigroup's Biopharma Back to School Summit 2026 Transcript

Scholar Rock Holding Corporation (SRRK) Presents at Citigroup's Biopharma Back to School Summit 2026 Transcript

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.

Scholar Rock: Manufacturing Noise Obscures A Muscle-Targeted Franchise

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.

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

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.

Scholar Rock to Present at Upcoming Investor Conferences

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.

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

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.

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

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.

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

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