Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Apitegromab (SRK-015) in Spinal muscular atrophy . The expected timing is based on the latest available company guidance and may change.
03/31/26:- Resubmitted SMA BLA; FDA acceptance expected within 30 days. PDUFA action expected Late September 2026. 05/07/26:- FDA accepted SAPPHIRE-based apitegromab BLA; PDUFA action date September 30, 2026; OPAL Ph2 enrolling infants. 07/19/26:- CHMP opinion timing depends on Catalent Indiana classification; could be later 2026. Update Aug 6, 2026. 08/06/26:- BLA review advancing; second facility package submitted; OPAL ongoing; PDUFA remains September 30, 2026. 08/07/26:- Catalent Indiana removed after OAI. Second fill-finish review progressing; PDUFA still September 30, 2026. 08/21/26:- Catalent Indiana removed from SMA BLA; EU application withdrawn Aug 20; Japan NDA planned YE 2026.
Verification
Confirm timing and program details against the company announcement or filing.