Summit Therapeutics upgraded to Hold as FDA reviews ivonescimab approval, decision expected by Nov 2026.

Summit Therapeutics Inc. has been upgraded from Sell to Hold amid the FDA's ongoing review of its biologics license application (BLA) for ivonescimab, with a decision expected by November 14, 2026. The company's pivotal HARMONI study showed statistically significant progression-free survival (PFS) but only a favorable trend in overall survival (OS). Updated data with a hazard ratio of 0.76 has been submitted to the FDA. Despite growing competition from large pharmaceutical companies developing similar therapies, no major partnerships or acquisition offers have emerged. Investors remain cautious, awaiting further data and clarity on Summit's ability to compete in the $90 billion PD-1 therapy market if approved.