Short answer
Celcuity Inc. (CELC) filed an 8-K current report with the SEC on May 1, 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 excerpt.
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 excerpt
- Text appears to be an exhibit-incorporation disclaimer, not investor-relevant operating information
Item 8.01 · Other Events
- Positive VIKTORIA-1 PIK3CA cohort results support gedatolisib’s potential in HR+/HER2- advanced breast cancer
- Both gedatolisib regimens delivered statistically significant, clinically meaningful PFS improvement versus alpelisib plus fulvestrant
- Generally well-tolerated treatment with manageable safety and no new safety signals
- Planned FDA sNDA submission and 2026 ASCO presentation create near-term regulatory and investor catalysts
- Results remain topline and subject to ongoing analysis, FDA review, approval, and market-acceptance risks
Item EX-99.1 · Exhibit EX-99.1
- Phase 3 VIKTORIA-1 met its primary endpoint, with statistically significant, clinically meaningful PFS improvement for the gedatolisib triplet versus alpelisib plus fulvestrant
- Gedatolisib doublet also significantly improved PFS versus alpelisib plus fulvestrant, supporting broader efficacy across regimens
- Generally well-tolerated safety profile with no new safety signals, strengthening gedatolisib’s regulatory and commercial positioning
- Celcuity plans an FDA supplemental NDA submission for PIK3CA-mutant disease, with detailed data scheduled for ASCO June 2, 2026
- Existing NDA for PIK3CA-wild-type disease has FDA Priority Review and a July 17, 2026 PDUFA goal date
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