Scholar Rock: Reiterating 'Strong Buy' On FDA Approval SMA And Expansions Now In Play

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.

Seeking Alpha • Sep 15, 2026

This Cellectis Analyst Is No Longer Bullish; Here Are Top 5 Downgrades For Tuesday

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our analyst ratings page.

Benzinga • Sep 15, 2026

Scholar Rock prices first drug to target SMA muscle loss at $11,659 per vial

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.

Reuters • Sep 14, 2026

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).

Benzinga • Sep 14, 2026

Scholar Rock Marks 'Defining Moment' with First Muscle-Targeted Treatment for Spinal Muscular Atrophy

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.

Benzinga • Sep 14, 2026

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

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

Seeking Alpha • Sep 14, 2026

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.

Reuters • Sep 11, 2026

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.

Business Wire • Sep 11, 2026

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

Seeking Alpha • Sep 10, 2026

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