Primärquellen-Eintrag
WesentlichAntrag angenommen
Scholar Rock: FDA accepts apitegromab BLA; PDUFA set for Sep 30 2026
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 · Zugelassen
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
Mehr zu diesem Asset
11. Sept. 2026
00:00
SRRKScholar Rock2. Sept. 2026
12:00
SRRKScholar RockScholar Rock: FDA Fast Track + Orphan Drug für Apitegromab bei FSHD
7. Aug. 2026
20:20
SRRKScholar Rock6. Aug. 2026
11:10
SRRKScholar Rock20. Juli 2026
12:00
SRRKScholar Rock