Celcuity Inc. - 8-K Filing
Celcuity Inc. announced positive results from its Phase 3 VIKTORIA-1 trial for gedatolisib in treating HR+/HER2- PIK3CA mutant-type advanced breast cancer. The gedatolisib-triplet regimen showed a median progression-free survival (PFS) of 11.1 months versus 5.6 months with alpelisib plus fulvestrant, and the doublet regimen had an even longer PFS at 11.3 months. Both regimens demonstrated higher objective response rates (48.9% for triplet; 35.7% for doublet) compared to 26.0%, along with durable responses. (Items: 7.01 Regulation FD Disclosure, 8.01 Other Events, 9.01 Financial Statements and Exhibits)
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