FDA Catalyst Calendar

PDUFA dates and FDA catalyst events

June 2026

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June Events

INCYPDUFA DATEpovorcitinib — hidradenitis suppurativapastJun 5, 2026
REGNPDUFA DATEfianlimab — adjuvant melanomapastJun 12, 2026
BEAMPDUFA DATEBEAM-101 — sickle cell diseasein 1 daysJun 15, 2026
VRTXPDUFA DATEsuzetrigine (VX-548) — moderate-to-severe acute pain sNDAin 6 daysJun 20, 2026
IONSPDUFA DATEdonidalorsen — hereditary angioedemain 11 daysJun 25, 2026
IMVTPDUFA DATEbatoclimab — thyroid eye diseasein 14 daysJun 28, 2026
NUVLPDUFA DATEzidesamtinib — ROS1+ NSCLCin 16 daysJun 30, 2026

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