Scholar Rock Resubmits Biologics License Application (BLA) to FDA for Apitegromab for Treatment of Children and Adults with Spinal Muscular Atrophy (SMA)
Scholar Rock Holding Corporation (SRRK)
Last scholar rock holding corporation earnings: 11/12 07:30 am
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Source: Business Wire
Apitegromab BLA resubmission includes Catalent Indiana LLC (part of Novo Nordisk) and second U.S.-based fill-finish facility, aligned with FDA guidance from March 3, 2026 Type C meetingFDA and Novo Nordisk Q1 2026 interactions resulted in Scholar Rock’s alignment with FDA to resubmit apitegromab BLA prior to FDA reinspection of Catalent Indiana facilityFDA and Scholar Rock Q1 2026 interactions regarding accelerated progress in qualifying a second fill-finish facility resulted in alignment with FDA to include facility in BLA resubmissionCompany anticipates FDA acceptance of BLA within 30 days and a review period of up to 6 months from date of resubmission, with PDUFA action date expected in late September 2026Management to host a conference call today at 8:00am ET CAMBRIDGE, Mass.--(BUSINESS WIRE)--Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of children and adults with spinal muscular atrophy (SMA) and additional rare, severe, and
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News
- Scholar Rock Reports New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)Business Wire
- Scholar Rock to Report First Quarter 2026 Financial Results on May 7, 2026Business Wire
- Scholar Rock (SRRK) Deepens SMA Manufacturing Footprint: Strategic Resilience Move or Regulatory Risk Signal? [Yahoo! Finance]Yahoo! Finance
- Scholar Rock (SRRK) had its price target raised by Wedbush from $56.00 to $58.00. They now have an "outperform" rating on the stock.MarketBeat
- Scholar Rock Resubmits Apitegromab BLA for SMA, Adds Second Fill-Finish Site; FDA Decision Eyed by Sept. [Yahoo! Finance]Yahoo! Finance
SRRK
Earnings
- 3/3/26 - Miss
SRRK
Sec Filings
- 4/6/26 - Form 144
- 3/31/26 - Form 8-K
- 3/27/26 - Form SCHEDULE
- SRRK's page on the SEC website