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Celcuity Inc. (CELC) filed an 8-K current report with the SEC on September 30, 2026 reporting Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1), Item 7.01 (Regulation FD Disclosure). REVTORPYK™ (gedatolisib) commercially available in the U.S. for eligible patients with HR+/HER2- locally advanced or metastatic breast cancer.
Celcuity Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- REVTORPYK™ (gedatolisib) commercially available in the U.S. for eligible patients with HR+/HER2- locally advanced or metastatic breast cancer
- Initial indication targets patients without a PIK3CA mutation after progression on at least one metastatic endocrine-therapy line
- Commercial availability marks transition from regulatory approval to potential product revenue generation
- Exhibit 99.1 contains the company’s supporting launch announcement
Item 8.01 · Other Events
- REVTORPYK commercially available in the U.S. for eligible HR+/HER2- advanced breast cancer patients
- Indicated after progression following at least one metastatic-setting endocrine therapy line
- Eligibility excludes patients with detected PIK3CA mutations
- Commercial launch expands potential revenue opportunity in the U.S. oncology market
Item EX-99.1 · Exhibit EX-99.1
- REVTORPYK became commercially available in the U.S. on September 30, 2026, initiating Celcuity’s first product launch
- FDA-approved for HR+/HER2- advanced breast cancer without detected PIK3CA mutation after at least one metastatic endocrine-therapy line
- Triplet reduced progression or death risk 76%; doublet reduced risk 67% versus fulvestrant in VIKTORIA-1’s PIK3CA wild-type cohort
- REVTORPYK Support Services launched with insurance navigation, copay assistance, and patient assistance programs
- Supplemental application submitted in August for PIK3CA-mutated disease, potentially expanding the eligible treatment population
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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