Summit Therapeutics: Upgrading To Hold As Critical Approval Decision Approaches
Summit Therapeutics was upgraded from Sell to Hold as the FDA reviews its BLA for ivonescimab, with a decision expected by November 14, 2026. The HARMONI study showed statistically significant progression-free survival but only a favorable trend in overall survival; updated hazard-ratio data of 0.76 was submitted.
Why it matters — SMMT shareholders are nearing a pivotal FDA approval decision on ivonescimab while facing intensifying competition and the lack of any acquisition or major partnership offers.