FDA Catalyst Calendar
Review upcoming FDA decisions, PDUFA dates and regulatory catalysts with source-linked records.
Data snapshot: 2026-10-14T11:47:58.610Z
| Ticker | Company | Drug / event | Date | Source |
|---|---|---|---|---|
| IRD | Opus Genetics, Inc. | PDUFA target action date | 2026-10-17 | Event source |
| VTRS | Viatris Inc. | PDUFA target action date | 2026-10-17 | Event source |
| IONS | IONIS PHARMACEUTICALS, INC. | PDUFA target action date | 2026-10-26 | Event source |
| INO | INOVIO PHARMACEUTICALS, INC. | PDUFA target action date | 2026-10-30 | Event source |
| AGIO | Agios Pharmaceuticals, Inc. | PDUFA target action date | 2026-11-01 | Event source |
| BTAI | BioXcel Therapeutics, Inc. | PDUFA target action date | 2026-11-14 | Event source |
| CYTK | CYTOKINETICS INC | PDUFA target action date | 2026-11-14 | Event source |
| SMMT | Summit Therapeutics Inc. | PDUFA target action date | 2026-11-14 | Event 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.