Short answer
Celcuity Inc. (CELC) filed an 8-K current report with the SEC on July 15, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). No substantive Regulation FD disclosure provided in the supplied text.
Celcuity Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- No substantive Regulation FD disclosure provided in the supplied text
Item 8.01 · Other Events
- Forward-looking disclosures center on gedatolisib’s clinical development, sNDA submission, FDA review, and commercialization potential
- Topline clinical results remain subject to ongoing efficacy and safety analysis, creating risk of data changes
- Key catalysts include regulatory approval, trial timing, market acceptance, and potential subcutaneous formulations
- Principal risks include clinical delays, competitive therapies, regulatory failure, and unfavorable access to capital
Item EX-99.1 · Exhibit EX-99.1
- FDA approval makes REVTORPYK Celcuity’s first commercial product for HR+/HER2-, PIK3CA wild-type advanced breast cancer
- VIKTORIA-1 triplet reduced progression or death risk 76%; median PFS 9.3 months versus 2.0 months
- Doublet reduced progression or death risk 67%; median PFS 7.4 months versus 2.0 months
- Commercial launch targeted for late Q3 2026, creating near-term execution and commercialization milestones
- Safety burden remains material, including stomatitis in 72% of triplet patients and Grade 3 stomatitis in 22%
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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