Gedatolisib is a Celcuity Inc. program in HR+/HER2- advanced breast cancer. The FDA approved it on Jul 14, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: HR+/HER2- advanced breast cancer (approved Jul 14, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Celcuity Inc. (CELC). Market-cap tier at the time we tracked it: Mid. We track 2 catalyst events for this program: 0 upcoming and 2 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 7,915,792 | $828.2 million | filed August 14, 2026 |
| Avoro Capital Advisors | 3,400,000 | $355.7 million | filed August 14, 2026 |
| RTW Investments | 3,304,903 | $345.8 million | filed August 14, 2026 |
| Perceptive Advisors | 3,197,200 | $334.5 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
No upcoming catalyst is on our calendar for Gedatolisib; 1 FDA decision is on record below.
On Jul 14, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Gedatolisib is FDA-approved for HR+/HER2- advanced breast cancer (approved Jul 14, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Celcuity Inc. (CELC).
Yes. The FDA approved an application for Gedatolisib on Jul 14, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.