Celcuity announced that two regimens of its experimental drug gedatolisib succeeded in PIK3CA-mutant breast cancer patients during a Phase 3 trial, marking a key milestone for the biotech. The company did not disclose specific efficacy or safety data in the release, but the win positions gedatolisib as a potential new option in a genetically defined patient population.
The positive results could reshape the treatment landscape for hormone receptor-positive breast cancer harboring PIK3CA mutations, a subtype with high unmet need. Existing therapies like alpelisib carry significant side effects, and physicians are eager for alternatives that might offer better tolerability without sacrificing efficacy.
On the financial front, Odyssey Therapeutics plans to raise $205 million through an initial public offering, according to a regulatory filing. The biotech, focused on immunology and oncology, previously raised over $400 million in private funding. Celcuity shares rose in pre-market trading on the news, though exact percentage gains were not specified.
Latus Bio, an early-stage gene therapy developer, extended its Series A financing round by an undisclosed amount. The firm is working on central nervous system disorders and has not yet disclosed clinical data. These moves underscore a broader trend of biotech companies tapping public markets after a prolonged drought in IPOs.
Analysts caution that Celcuity still faces regulatory and commercial risks, including the need to submit full Phase 3 results for FDA review. The data will be presented at an upcoming medical meeting, offering more clarity on the drug's profile.