FDA Catalyst Calendar

PDUFA dates and FDA catalyst events

May 2026

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May Events

TVTXPDUFA DATEsparsentan — IgA nephropathypastMay 1, 2026
PFEPDUFA DATEmarstacimab — hemophilia A/BpastMay 10, 2026
ACADPDUFA DATEpimavanserin — Alzheimer's disease psychosispastMay 10, 2026
PRAXPDUFA DATEPRAX-114 — major depressive disorderpastMay 18, 2026
ALNYPDUFA DATEvutrisiran (Amvuttra) — ATTR polyneuropathy sNDApastMay 22, 2026
GMABPDUFA DATEteclistamab — relapsed/refractory multiple myelomain 4 daysMay 28, 2026
GILDPDUFA DATElenacapavir — HIV PrEPin 6 daysMay 30, 2026

Not financial advice. Data by Guerilla Finance Inc. for informational purposes only. Always conduct your own due diligence.