The FDA accepted the Biologics License Application (BLA) under priority review for a drug candidate, apitegromab, developed by Scholar Rock Holding for the treatment of Spinal Muscular Atrophy (SMA).
7 reports, 5 independent
Updated Sep 21
Gone quiet
Reached 3 outlets in its first 24 hours
- Reports
- 7
- Developments
- 3
- Repetition
- 57%
New informationRepeats or wire copies
AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.
What happened
The FDA accepted the Biologics License Application (BLA) under priority review for a drug candidate, apitegromab, developed by Scholar Rock Holding for the treatment of Spinal Muscular Atrophy (SMA).
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.FDA approves SMA drug; UPenn responds to measles outbreak.1 source
FDA is reviewing apitegromab application; development uses alternate facility.1 source
FDA accepts BLA for apitegromab (Scholar Rock Holding) targeting SMA.1 source
Keep exploring
The entities involved
Related events
- The FDA placed a clinical hold on the IND application for the company Aardvark.
- BioXcel Therapeutics received FDA approval for its drug and announced results from New Haven.
- Shares of Scholar Rock Holding Corporation were traded on the Nasdaq exchange while the FDA approved ISEMBYLD for spinal muscular atrophy.
Coverage
Newest first; wire copies grouped- newsroomamerica.com
- yahoo.com
- Simply Wall St.A Closer Look at Scholar Rock (SRRK) Valuation Following Landmark Phase 3 Data and FDA Priority Review Scholar Rock Holding (SRRK) just captured the spotlight thanks to a major clinical milestone. Th
- Motley FoolWhy Scholar Rock Stock Wilted on Wednesday The company posted a relatively steep bottom-line shortfall in its second quarter. This was tempered by a business update that featured more positive news.
- Business WireScholar Rock Reports Second Quarter 2025 Financial Results and Highlights Business Progress FDA accepted the apitegromab BLA under priority review with a PDUFA target action of September 22, 2025; fi
- Business WireScholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) CAMBRIDGE, Mass., July 18, 2025--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK; the "Company"), a late-stage bio
- Unknown outlet