FDA Acceptance of Ivonescimab Could Unlock 296% Upside for Summit Therapeutics
Summit Therapeutics’ U.S. FDA has accepted its ivonescimab application for lung cancer, targeting 14,000 U.S. patients annually with a PDUFA decision set for November 14, 2026. Six analysts cover the stock with four Buy and two Hold ratings, implying a 1-year median price target of $57.98, +296% upside.
1. FDA Acceptance of Ivonescimab Application
On January 29, U.S. FDA accepted Summit Therapeutics’ application for ivonescimab, a bispecific antibody combining PD-1 blockade and anti-angiogenesis in lung cancer patients who have progressed on targeted therapies. The submission is supported by global Phase III HARMONi trial data, with a PDUFA decision slated for November 14, 2026.
2. Analyst Coverage and Price Targets
As of February 12, six analysts cover the stock, issuing four Buy and two Hold ratings and no Sell calls. They set a median 12-month price target of $57.98, implying approximately 296% upside from current levels.
3. Market Opportunity and Partnerships
The U.S. application seeks to address an estimated 14,000 eligible patients annually in the post-targeted therapy lung cancer segment. Summit Therapeutics also leverages existing commercial exposure in China through its partnership with Akeso to bolster future revenue streams.