Summit Therapeutics shares surge 10.32% intraday as FDA filing gamble sparks optimism.

Summit Therapeutics surged 10.32% intraday following news that the company plans to file a Biologics License Application (BLA) with the FDA for ivonescimab in combination with chemotherapy as a second-line treatment for non-small cell lung cancer by year-end. The FDA previously indicated that ivonescimab plus chemo required a statistically significant overall survival benefit for approval, a threshold not met in the Harmoni trial. However, Summit’s management believes the FDA may revise its stance based on remaining safety and efficacy data from the study. The BLA submission, a binary catalyst, could trigger significant stock volatility, as acceptance or rejection will determine the drug’s regulatory path. The move aligns with recent positive media coverage of the company’s strategic gamble and insider share purchases, though risks remain if the FDA adheres to its initial guidance.