Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer
Celcuity submitted a supplemental New Drug Application to the FDA seeking approval for REVTORPYK (gedatolisib) in patients with HR+/HER2-, PIK3CA-mutant locally advanced or metastatic breast cancer after progression. The filing creates an FDA-review catalyst for CELC.
Celcuity said on Aug. 26, 2026 that it submitted the sNDA to the FDA for REVTORPYK, also known as gedatolisib. The proposed use covers patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer carrying a PIK3CA mutation after progression on or after prior treatment.
The named company is Celcuity Inc. (Nasdaq: CELC), and the regulatory mechanism is a supplemental application for an existing product rather than a new molecular entity filing. The next concrete developments are FDA validation or acceptance of the submission, any assigned review timeline, and subsequent regulatory communications.
The sNDA moves CELC into an FDA-review catalyst, with the upside case tied to regulatory acceptance and eventual approval rather than the filing itself.
The filing gives CELC a defined regulatory pathway, but the announcement supplies no FDA acceptance, review date, efficacy figures, or safety data to support a conviction trade. The immediate read is therefore event-driven and positive in setup, with the decisive information still ahead in the FDA process.
The trade fails if the FDA declines to accept the sNDA, requests additional information, or the eventual review does not support the proposed indication.
CoverageSource: GlobeNewswire · Published here WED, AUG 26 · 8:30 AM ET · the only report in this recordHow this is decided →
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FDA acceptance and a subsequent approval for the PIK3CA-mutant breast-cancer indication would expand the commercial opportunity for REVTORPYK.
The filing alone is not an approval, and there is no clinical or regulatory evidence showing that FDA acceptance or approval is assured.
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