secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K/A
Filed at:   2026-07-15T20:05:43+00:00
Accession:  0001493152-26-033357
Event type: regulatory
Sentiment:  positive
Materiality: 0.90
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Celcuity receives FDA approval for REVTORPYK (gedatolisib) in HR+/HER2- breast cancer
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- FDA approved REVTORPYK for HR+/HER2- PIK3CA wild-type advanced/metastatic breast cancer after endocrine therapy.
- In VIKTORIA-1 trial, REVTORPYK triplet reduced risk of progression/death by 76% vs fulvestrant (HR=0.24; median PFS 9.3 vs 2.0 months).
- REVTORPYK doublet reduced risk by 67% (HR=0.33; median PFS 7.4 vs 2.0 months).
- Commercial launch expected late Q3 2026; sNDA for PIK3CA mutated cohort planned in Q3 2026.
- REVTORPYK is first pan-PI3K/mTORC1/2 inhibitor approved by FDA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226033357/0001493152-26-033357-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000149315226033357/form8-ka.htm
  HTML page:      https://secwatch.observer/filing/0001493152-26-033357

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