Celcuity Inc. 8K

Celcuity submitted an sNDA to the FDA to expand REVTORPYK’s indication to include HR+/HER2-, PIK3CA-mutant advanced breast cancer based on positive Phase 3 VIKTORIA-1 results.

Celcuity Inc. announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to expand the label for its recently approved drug REVTORPYK (gedatolisib) to include treatment of patients with HR+/HER2-, PIK3CA-mutant locally advanced or metastatic breast cancer following progression on at least one line of endocrine therapy, supported by positive Phase 3 VIKTORIA-1 trial data showing substantial improvements in progression-free survival versus alpelisib plus fulvestrant and safety consistent with prior results, which, if approved, would broaden the commercial opportunity for REVTORPYK and make it the first therapy for advanced PIK3CA‑mutant breast cancer that inhibits all class I PI3K isoforms and both mTORC1 and mTORC2.

Filing Facts

CIK

1603454

Ticker

-

Form

8K

Source Type

sec

Accession

0001193125-26-365975

Alert Tier

6