secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-08-26T12:35:14+00:00
Accession:  0001193125-26-365975
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity files sNDA for REVTORPYK in PIK3CA-mutant advanced breast cancer
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- sNDA seeks FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- ABC with PIK3CA mutation after ≥1 endocrine therapy.
- Phase 3 VIKTORIA-1: triplet cut progression/death risk by 50% vs alpelisib+fulvestrant (HR=0.50, p<0.0001); median PFS 11.1 vs 5.6 months.
- Doublet: HR=0.51 (p=0.0013), median PFS 11.3 vs 5.6 months; ORR 49% (triplet) and 36% (doublet).
- If approved, first therapy for PIK3CA-mutant ABC inhibiting all class I PI3K isoforms and mTORC1/C2.
- FDA approved REVTORPYK for PIK3CA wild-type ABC on July 14, 2026; this submission expands to mutant population.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/0001193125-26-365975-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000119312526365975/celc-20260826.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-365975

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer