FDA Grants Priority Review for Biologics License Application (BLA) and EMA Accepts Marketing Authorisation Application (MAA) for Apitegromab as a Treatment for Spinal Muscular Atrophy
Scholar Rock Holding Corporation (SRRK)
Last scholar rock holding corporation earnings: 11/12 07:30 am
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Source: Business Wire
Apitegromab remains on track to be the first and only muscle-targeted treatment for people living with Spinal Muscular AtrophyFDA to review BLA application under priority review, with a PDUFA date of September 22, 2025Apitegromab Marketing Authorisation Application to the European Medicines Agency validated and under review CAMBRIDGE, Mass.--(BUSINESS WIRE)--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 treatment that is being developed to provide clinically meaningful improvement in motor function for people living with spinal muscular atrophy (SMA) who are receiving an SMN-targeted treatment. The FDA will review the application under priority review and has assigned a
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News
- Scholar Rock (NASDAQ:SRRK) had its "overweight" rating reaffirmed by analysts at Barclays PLC.MarketBeat
- Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Scholar Rock (NASDAQ:SRRK) had its "overweight" rating reaffirmed by analysts at Cantor Fitzgerald.MarketBeat
- Scholar Rock (SRRK) valuation after FDA manufacturing update and apitegromab resubmission plans [Yahoo! Finance]Yahoo! Finance
- Scholar Rock Holding Corporation (SRRK) Presents at Citi Annual Global Healthcare Conference 2025 Transcript [Seeking Alpha]Seeking Alpha
SRRK
Earnings
- 11/14/25 - Miss
SRRK
Sec Filings
- 12/18/25 - Form 4
- 12/16/25 - Form 4
- 12/16/25 - Form 144
- SRRK's page on the SEC website