FDA Catalyst Calendar
Upcoming and recent FDA regulatory events compiled from SEC EDGAR filings, FDA press releases, and company announcements.
272 Catalyst Events
| Date | Company | Drug | Event Type | Status | Source |
|---|---|---|---|---|---|
| Aug 1, 2026 |
RGNX
REGENXBIO Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
ACIU
AC Immune SA |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
TNYA
Tenaya Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
SLGL
Sol-Gel Technologies Ltd. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
KPTI
Karyopharm Therapeutics Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
ATNM
Actinium Pharmaceuticals, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
CWLXF
C21 Investments Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
IGC
IGC Pharma, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
INTI
Inhibitor Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
HYEX
HEALTHY EXTRACTS INC. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
BIVI
BIOVIE INC. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
NCNA
NuCana plc |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
ENSC
Ensysce Biosciences, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
NTRR
NEUTRA CORP. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
TNYA
Tenaya Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
GSK
GSK plc |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
CORT
CORCEPT THERAPEUTICS INC |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
CATX
Perspective Therapeutics, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
SXTC
China SXT Pharmaceuticals, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
ICLR
ICON PLC |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
OPTN
Option Therapeutics Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
SXTC
China SXT Pharmaceuticals, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
BGMS
Bio Green Med Solution, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
LLY
ELI LILLY & Co |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
TKNO
Alpha Teknova, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
OPTN
Option Therapeutics Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
LLY
ELI LILLY & Co |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
GLUC
Glucose Health, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
OSTX
OS Therapies Inc |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
INTI
Inhibitor Therapeutics, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
IVVD
Invivyd, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
LLY
ELI LILLY & Co |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
LLY
ELI LILLY & Co |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
OSTX
OS Therapies Inc |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
OSTX
OS Therapies Inc |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
LLY
ELI LILLY & Co |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
LLY
ELI LILLY & Co |
— | Phase2 Readout | Upcoming | Source |
| Aug 3, 2026 |
OPTN
Option Therapeutics Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 4, 2026 |
AGEN
AGENUS INC |
— | Phase2 Readout | Upcoming | Source |
| Aug 4, 2026 |
JNJ
JOHNSON & JOHNSON |
— | Phase2 Readout | Upcoming | Source |
| Aug 5, 2026 |
MRNA
Moderna, Inc. |
— | Pdufa | Upcoming | Source |
| Aug 5, 2026 |
MRK
Merck & Co., Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 6, 2026 |
MBIO
MUSTANG BIO, INC. |
— | Phase1 Readout | Upcoming | Source |
| Aug 8, 2026 |
TNYA
Tenaya Therapeutics, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 8, 2026 |
SNY
Sanofi |
— | Phase3 Readout | Upcoming | Source |
| Aug 10, 2026 |
INCY
INCYTE CORP |
— | Phase3 Readout | Upcoming | Source |
| Aug 13, 2026 |
LNTH
Lantheus Holdings, Inc. |
— | Pdufa | Upcoming | Source |
| Aug 13, 2026 |
JSPR
Jasper Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 13, 2026 |
GLUC
Glucose Health, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 14, 2026 |
IQV
IQVIA HOLDINGS INC. |
— | Phase3 Readout | Upcoming | Source |
About This Calendar
Catalyst events are compiled from official public sources: FDA press releases (fda.gov), SEC EDGAR 8-K filings, company press releases via GlobeNewsWire and PR Newswire. PDUFA target action dates are sourced from company SEC filings and press releases — the FDA does not publish a public PDUFA calendar. Dates are targets and may change due to FDA extensions, Major Amendments, or NDA withdrawals.
Data updates every 15 minutes. Historical events reflect the date the information was published, not necessarily the date of the FDA action.