Primärquellen-Eintrag
WesentlichAntrag angenommen
Scholar Rock: FDA nimmt BLA für Apitegromab an; PDUFA-Termin auf den 30. September 2026 festgelegt
FDA accepted the apitegromab BLA for SMA with a PDUFA action date of September 30, 2026. The filing covers two fill-finish sites, one of which (Catalent Indiana) has already been reinspected. The company is prepared for immediate U.S. launch upon approval.
Kernfakten
- Eingereicht
- 7. Mai 2026, 11:10
- Ereignis
- Antrag angenommen
- Richtung
- Positiv
- Unternehmen
SRRKScholar Rock- Asset
- apitegromab
- Quelle
- SEC 8-K
- Belegstatus
- Belegt
- Kalender
- FDA-Entscheidung (PDUFA) · 30. Sept. 2026 · Complete Response Letter
Auszug aus der Quelle
EX-99.1 2 srrk-20260507xex99d1.htm EX-99.1 Exhibit 99.1 Exhibit 99.1 Scholar Rock Reports First Quarter 2026 Financial Results and Recent Business Highlights • FDA accepted apitegromab Biologics License Application (BLA) for treatment of children and adults with spinal muscular atrophy (SMA) with September 30, 2026 Prescription Drug User Fee Act (PDUFA) action date • Accepted apitegromab BLA includes two fill-finish facilities, Catalent Indiana LLC (part of Novo Nordisk), and a second U.S.-based facility • FDA has completed reinspection of Catalent Indiana; classification of facility expected within 90 days following reinspection, in accordance with FDA guidelines • Second fill-finish facility on track to have commercial apitegromab supply in early Q3 2026 • Scholar Rock is prepared for U.S. apitegromab launch immediately upon FDA approval, which may be granted at any time through September 30, 2026 • Cash, cash equivalents, and marketable securities of $480 million as of March 31, 2026; includes an additional $100 million in debt and $98 million in net cash proceeds from the Company’s at-the-market (ATM) program • Management to host a conference call today at 8:00 a.m. ET CAMBRIDGE, Mass.--(BUSINESS WIRE)— May 7, 2026 — 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 debilitating neuromuscular diseases by applying its leading platform
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