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AI brief of an SEC Form 8-K · Celcuity Inc. (CELC)

Celcuity says REVTORPYK now commercially available in U.S. for eligible breast cancer patients

Neutral Impact 3 of 5 product/contract Written later

Celcuity announced on September 30, 2026 that REVTORPYK (gedatolisib) is now commercially available in the United States, following FDA approval on July 14, 2026 for certain HR+/HER2- advanced breast cancer patients without a PIK3CA mutation. The filing marks the start of commercial sales for the company's first FDA-approved product, though it does not disclose any sales, revenue or financial figures.

Key points

  • FDA approved REVTORPYK on July 14, 2026, in combination with palbociclib and fulvestrant, and with fulvestrant alone.
  • Eligible patients are those with HR+/HER2- advanced breast cancer without a PIK3CA mutation who progressed after at least one line of endocrine therapy in the metastatic setting.
  • Celcuity launched the REVTORPYK Support Services program to help with insurance coverage and financial assistance.
  • A supplemental New Drug Application for the PIK3CA mutated population was submitted to the FDA in August 2026.

The filing

CompanyCelcuity Inc. (CELC)
Form8-K, current report
Filed with the SECSep 30, 2026, 8:05 AM ET
Accession number0001193125-26-408353

Items reported: 7.01 Regulation FD Disclosure8.01 Other Events

Read the filing on SEC.gov ↗

Written by AI on Nov 9, 2026, 8:38 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on September 30, 2026.

Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.