Gedatolisib with Fulvestrant was approved by the FDA on July 14, 2026 for HR+/HER2- advanced breast cancer, the 25th novel drug approval of 2026 on the FDA's Novel Drug Approvals list.
REVTORPYK (gedatolisib) plus fulvestrant approved for HR+/HER2−, PIK3CA wild-type advanced breast cancer (Jul 14 2026).
The PDUFA goal date was July 17, 2026; the FDA approved on July 14, 2026, three days early. This page previously carried another company's chart, indication and dates through a template-copy bug; it was rebuilt from Celcuity's own price history on July 15, 2026. See /corrections.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: Celcuity investor releases
FDA record of the action: the FDA approved on July 14, 2026, per NDA 219908 ORIG-1 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
| 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.
Yes. The FDA approved the application for Gedatolisib with Fulvestrant on July 14, 2026, per the FDA's own record. The primary source is linked on this page.
Gedatolisib with Fulvestrant is a Celcuity Inc. (CELC) program. The FDA decision came on July 14, 2026; the company's own announcement is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), CELC moved -1.5%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.