NexVeris AI

FDA Catalyst Calendar

Review upcoming FDA decisions, PDUFA dates and regulatory catalysts with source-linked records.

Data snapshot: 2026-10-14T11:47:58.610Z

TickerCompanyDrug / eventDateSource
IRDOpus Genetics, Inc.PDUFA target action date2026-10-17Event source
VTRSViatris Inc.PDUFA target action date2026-10-17Event source
IONSIONIS PHARMACEUTICALS, INC.PDUFA target action date2026-10-26Event source
INOINOVIO PHARMACEUTICALS, INC.PDUFA target action date2026-10-30Event source
AGIOAgios Pharmaceuticals, Inc.PDUFA target action date2026-11-01Event source
BTAIBioXcel Therapeutics, Inc.PDUFA target action date2026-11-14Event source
CYTKCYTOKINETICS INCPDUFA target action date2026-11-14Event source
SMMTSummit Therapeutics Inc.PDUFA target action date2026-11-14Event source

Review milestones and final decisions

A target action date, advisory committee meeting and final FDA decision are different milestones. Confirm the type of event in its original record before treating it as an approval.

Source dates can change

Check the recorded update time and any later company or FDA announcement. The calendar preserves the stated date and source; it does not guarantee an intraday announcement time.