Scholar Rock

6 days ago · seekingalpha.com

Scholar Rock Holding Corporation maintains a "Strong Buy" rating following FDA approval of ISEMBYLD [apitegromab] for SMA in patients ≥2 years old. SRRK targets a $2B+ market opportunity in SMA, with expansion potential into younger populations, subcutaneous formulations, and new indications like FSHD. Regulatory catalysts include planned MAA resubmission in Europe and anticipated JNDA filing in Japan by year-end 2026, leveraging a validated manufacturing facility.

8 days ago · seekingalpha.com

Scholar Rock Holding Corporation (SRRK) Discusses FDA Approval and Clinical Impact of ISEMBYLD in SMA Treatment Transcript

8 days ago · benzinga.com

The U.S. Food and Drug Administration on Friday approved ISEMBYLD (apitegromab-mstn) from Scholar Rock (NASDAQ:SRRK) for spinal muscular atrophy (SMA) in adults and pediatric patients aged 2 years and older.

8 days ago · reuters.com

Scholar Rock on Monday ​set a list ‌price of $11,659 per single-use vial ​for its ​newly approved spinal muscular ⁠atrophy drug, ​the first therapy ​that directly targets muscle loss in ​patients with ​the rare genetic disorder.

8 days ago · benzinga.com

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).

11 days ago · businesswire.com

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.

11 days ago · reuters.com

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

12 days ago · seekingalpha.com

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

1 month ago · marketbeat.com

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.

2 months ago · businesswire.com

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.