Celcuity reports breast cancer trial results
Celcuity announced positive topline results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 trial in HR+/HER2-negative advanced or metastatic breast cancer. Gedatolisib with fulvestrant and palbociclib, and gedatolisib with fulvestrant, each showed statistically significant progression-free survival improvement versus alpelisib and fulvestrant comparisons. The company said both regimens were generally well tolerated with manageable safety and no new safety signals. Celcuity plans to submit the data to the FDA as a supplemental New Drug Application and later to other regulators. Shares have surged over 1,000% in the past year, though InvestingPro says the stock appears overvalued and the company remains unprofitable.
Celcuity plans an FDA sNDA after Phase 3 results.
Context
Celcuity already has an FDA Priority Review for gedatolisib in another HR+/HER2- group.…
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