Minneapolis-based Celcuity announced positive topline results from its phase III Viktoria-1 trial evaluating gedatolisib combined with endocrine therapies in advanced HR+, HER2-, PIK3CA wild-type breast cancer. The therapy significantly reduced disease progression risks in patients who progressed after CDK4/6 inhibitors and aromatase inhibitors, achieving both primary endpoints with clinically meaningful improvements. Favorable tolerability profiles and progression-free survival gains position Celcuity to pursue FDA approval filings in late 2025. The data sparked a dramatic increase in the company's share price, reflecting investor optimism on the potential market impact of this new treatment option.