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 |
|---|---|---|---|---|---|
| Jul 13, 2026 |
CNTB
Connect Biopharma Holdings Ltd |
— | Phase2 Readout | Upcoming | Source |
| Jul 13, 2026 |
INCY
INCYTE CORP |
— | Phase3 Readout | Upcoming | Source |
| Jul 15, 2026 |
SXTP
60 DEGREES PHARMACEUTICALS, INC. |
— | Phase2 Readout | Upcoming | Source |
| Jul 15, 2026 |
PFE
PFIZER INC |
— | Phase1 Readout | Upcoming | Source |
| Jul 16, 2026 |
VRTX
VERTEX PHARMACEUTICALS INC / MA |
— | Phase1 Readout | Upcoming | Source |
| Jul 20, 2026 |
NAGE
Niagen Bioscience, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 21, 2026 |
SXTC
China SXT Pharmaceuticals, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 22, 2026 |
INCY
INCYTE CORP |
— | Phase2 Readout | Upcoming | Source |
| Jul 23, 2026 | Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk Drug Substances Nominated for Inclusion on the Section 503A Bulk Drug Substances List | — | Adcom | Upcoming | Source |
| Jul 23, 2026 |
BNTX
BioNTech SE |
— | Phase3 Readout | Upcoming | Source |
| Jul 24, 2026 |
JNJ
JOHNSON & JOHNSON |
— | Phase3 Readout | Upcoming | Source |
| Jul 24, 2026 |
GLUC
Glucose Health, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 26, 2026 |
MNKD
MANNKIND CORP |
— | Pdufa | Upcoming | Source |
| Jul 28, 2026 |
LTRN
Lantern Pharma Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 29, 2026 |
OTLK
Outlook Therapeutics, Inc. |
— | Pdufa | Upcoming | Source |
| Jul 29, 2026 | Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells) | — | Adcom | Upcoming | Source |
| Jul 30, 2026 |
VTRS
Viatris Inc |
— | Pdufa | Upcoming | Source |
| Jul 30, 2026 | Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec | — | Adcom | Upcoming | Source |
| Jul 30, 2026 |
QNRX
Quoin Pharmaceuticals, Ltd. |
— | Phase3 Readout | Upcoming | Source |
| Jul 30, 2026 |
SXTC
China SXT Pharmaceuticals, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Jul 30, 2026 |
INTI
Inhibitor Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 30, 2026 |
INTI
Inhibitor Therapeutics, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Jul 31, 2026 |
ONC
BeOne Medicines Ltd. |
— | Phase3 Readout | Upcoming | Source |
| Jul 31, 2026 |
BNTX
BioNTech SE |
— | Phase3 Readout | Upcoming | Source |
| Jul 31, 2026 |
IBRX
ImmunityBio, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 31, 2026 |
JANX
Janux Therapeutics, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Jul 31, 2026 |
HSTC
HST Global, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Jul 31, 2026 |
OSTX
OS Therapies Inc |
— | Phase1 Readout | Upcoming | Source |
| Jul 31, 2026 |
INTI
Inhibitor Therapeutics, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Jul 31, 2026 |
OSTX
OS Therapies Inc |
— | Phase1 Readout | Upcoming | Source |
| Jul 31, 2026 |
INTI
Inhibitor Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Jul 31, 2026 |
BGMS
Bio Green Med Solution, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
BFRG
BullFrog AI Holdings, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
RCUS
Arcus Biosciences, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
ARGX
ARGENX SE |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
BNTX
BioNTech SE |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
MIRM
Mirum Pharmaceuticals, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
GRFS
Grifols SA |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
XENE
Xenon Pharmaceuticals Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
MANE
Veradermics, Inc |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
GPCR
Structure Therapeutics Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
OVID
Ovid Therapeutics Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
KOD
Kodiak Sciences Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
PHVS
Pharvaris N.V. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
KURA
Kura Oncology, Inc. |
— | Phase1 Readout | Upcoming | Source |
| Aug 1, 2026 |
ANRO
Alto Neuroscience, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
ACRS
Aclaris Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
CADL
Candel Therapeutics, Inc. |
— | Phase2 Readout | Upcoming | Source |
| Aug 1, 2026 |
IVVD
Invivyd, Inc. |
— | Phase3 Readout | Upcoming | Source |
| Aug 1, 2026 |
RGNX
REGENXBIO Inc. |
— | Phase2 Readout | Upcoming | Source |
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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.