ODINSIGNAL JOURNAL · NEWS & EVENTS
FDA decision on bezuclastinib for non‑advanced systemic mastocytosis slated for Dec 30 2026
Cogent Biosciences' bezuclastinib has a PDUFA target date of Dec 30 2026 for non‑advanced systemic mastocytosis. The FDA decision is upcoming.
At a glance
- Event
- FDA decision (PDUFA) target Dec 30, 2026
- Date
- Dec 30, 2026
- Participants
- Cogent Biosciences
Cogent Biosciences' experimental drug bezuclastinib is under FDA review for the rare condition non‑advanced systemic mastocytosis. The agency has set a PDUFA target date of Dec 30 2026 – the deadline by which a decision (approval, complete response letter, or possible extension) is expected. As of the latest update on November 5 2026, the entry appears as the next FDA decision on the public PDUFA calendar (PDUFA calendar). The market will resolve based on the FDA’s action by the end of 2026.
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