secwatch.observer — SEC 8-K summary
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Issuer:     Celcuity Inc. (CELC)
CIK:        0001603454
Form:       8-K
Filed at:   2026-09-30T12:05:14+00:00
Accession:  0001193125-26-408353
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

Celcuity's REVTORPYK (gedatolisib) now commercially available in US for HR+/HER2- advanced breast cancer
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- FDA approved REVTORPYK on July 14, 2026 as a triplet with palbociclib and fulvestrant, and as a doublet with fulvestrant, for HR+/HER2- ABC without a PIK3CA mutation.
- In the Phase 3 VIKTORIA-1 PIK3CA wild-type cohort, the REVTORPYK triplet and doublet cut risk of disease progression or death by 76% and 67% versus fulvestrant.
- Celcuity launched REVTORPYK Support Services offering insurance coverage, Copay Assistance and Patient Assistance help; contact 877-423-5284 or www.revtorpykhcp.com.
- A supplemental NDA was submitted to the FDA in August for REVTORPYK in HR+/HER2-, PIK3CA-mutated advanced breast cancer based on Study 2 of VIKTORIA-1.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1603454/000119312526408353/0001193125-26-408353-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1603454/000119312526408353/celc-20260930.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-408353

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