Short answer
Celcuity Inc. (CELC) filed an 8-K current report with the SEC on August 26, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events). Celcuity submitted an sNDA to the FDA for REVTORPYK™ in PIK3CA-mutated HR+/HER2- advanced breast cancer.
Celcuity Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Celcuity submitted an sNDA to the FDA for REVTORPYK™ in PIK3CA-mutated HR+/HER2- advanced breast cancer
- Target population: locally advanced or metastatic disease after at least one endocrine-therapy line
- FDA submission creates a potential regulatory catalyst, with approval timing and outcome remaining key investor variables
- Full press release furnished as Exhibit 99.1
Item 8.01 · Other Events
- sNDA submitted to FDA for REVTORPYK in HR+/HER2- advanced breast cancer with PIK3CA mutations
- Target population includes patients progressing after at least one endocrine-therapy line
- FDA submission advances potential label expansion and creates a regulatory catalyst for Celcuity
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
Other Celcuity Inc. 8-K filings
Get the next CELC 8-K as it lands
Follow CELC for push alerts, or ask the research agent what this filing means.