Celcuity
1 products tracked · names used in filings: Celcuity, Celcuity Inc.
Upcoming milestones
No upcoming milestones listed.
Recent milestones
Fri 17 Jul 2026🇺🇸 PDUFA datecompany-announced
gedatolisib: PDUFA target action date (HR+/HER2- PIK3CA wild-type advanced or metastatic breast cancer)
Celcuity Inc. (CELC); gedatolisib; NDA; status: set; "The FDA has granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2- PIK3CA wild-type (“WT”) ABC and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026."; filed 2026-06-02 · source
Tue 14 Jul 2026🇺🇸 FDA approval
FDA approves Revtorpyk (gedatolisib), a new medicine
Celcuity; NDA219908; New molecular entity, Priority review; powder · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Revtorpyk gedatolisib | Approved | 2026-07-14 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.