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Celcuity Inc. (CELC) filed an 8-K current report with the SEC on June 2, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events). Filing text contains only incorporation-by-reference disclaimer language.
Celcuity Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Filing text contains only incorporation-by-reference disclaimer language
- No substantive Regulation FD disclosure or investor-actionable information provided
Item 8.01 · Other Events
- VIKTORIA-1 triplet doubled median PFS to 11.1 months versus 5.6 months for alpelisib plus fulvestrant
- Triplet ORR 48.9% versus 26.0%, with median DOR 15.7 months versus 7.5 months
- Doublet delivered 11.3-month median PFS versus 5.6 months, with 35.7% ORR and 24.2-month median DOR
- Grade 3+ neutropenia affected 58.8% of triplet patients, highlighting a key commercialization and tolerability risk
- sNDA planned; FDA PDUFA date July 17, 2026 for PIK3CA WT NDA, with commercial launch targeted for third quarter 2026
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