
Shares of drug developer Summit Therapeutics SMMT.O fall 20.2% to $20.91
Co says its experimental lung cancer therapy ivonescimab in combination with chemotherapy showed a positive trend in overall survival, but "without achieving a statistically significant benefit" in a global late-stage trial
However, co says the therapy showed meaningful improvement in progression free survival or the time patients live without their disease progressing
Co says the "FDA noted that a statistically significant overall survival benefit is necessary to support marketing authorization," which will weigh into its considerations regarding the timing of filing its US marketing application for ivonescimab
"Should Summit apply for approval with these data, it is unclear whether the new FDA regime would be willing to consider the totality of the data vs. standing firm on one datapoint"- brokerage Clear Street
SMMT is testing ivonescimab to treat patients with a type of lung cancer who have progressed after prior treatment
Up to last close, stock up 46.9% YTD