Celcuity Inc. 8K

Celcuity Inc. reported FDA approval of REVTORPYK (gedatolisib) for HR+/HER2-, PIK3CA wild-type advanced or metastatic breast cancer and outlined commercialization and further regulatory plans.

On July 14, 2026, Celcuity Inc. announced that the U.S. Food and Drug Administration approved its drug REVTORPYK (gedatolisib), a first-in-class pan-PI3K and mTORC1/2 inhibitor, for use in combination with fulvestrant, with or without palbociclib, to treat adult patients with HR-positive/HER2-negative, PIK3CA wild-type locally advanced or metastatic breast cancer following progression on at least one line of endocrine therapy in the metastatic setting, with approval based on strong Phase 3 VIKTORIA-1 trial data and accompanied by plans for a late Q3 2026 commercial launch, an expanded access program, and a forthcoming sNDA in Q3 2026 for PIK3CA-mutated disease and additional global regulatory filings.

Filing Facts

CIK

1603454

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-033357

Alert Tier

8