Summit shares close at $14.15 ahead of FDA target date for ivonescimab decision
Key Facts
Summit Therapeutics shares, listed under the ticker SMMT, closed at $14.15 in the November 13, 2026, session, according to EL7 data. The close came one day before the target date set by the U.S. Food and Drug Administration to take action on the ivonescimab biologics license application, according to the company’s filing with the Securities and Exchange Commission. The date puts the application review at the forefront of developments Summit is monitoring for the experimental drug in the United States. The issuance of a complete response letter could not be confirmed from a reliable public announcement, so a rejection of the application cannot be treated here as a verified development. Summit’s filing said the agency’s expected decision concerns the drug’s biologics license application.
The application was based on results from the global Phase 3 HARMONi trial, which met its primary endpoint of progression-free survival. The hazard ratio for progression-free survival was 0.52 in the primary analysis, with a p-value of less than 0.0001, according to Summit’s filing. But the initial overall survival analysis showed a positive trend without reaching statistical significance. The company said the FDA had told it that demonstrating a statistically significant overall survival benefit was necessary to support approval in this context. This requirement puts the overall survival result at the center of the application review, alongside the progression-free survival result achieved in the trial.
In an updated analysis announced in September, Summit said the overall survival hazard ratio was 0.76 in the global intention-to-treat population, with a nominal p-value of 0.0151; the analysis covered the period through June 2026. The Western patient population also showed an overall survival hazard ratio of 0.76, and the company said these results were made available to the FDA. The HARMONi trial was conducted at 114 centers and cancer hospitals in Asia, Europe and North America, according to the filing. The company said China approved the drug with chemotherapy in May 2024 for a specific group of patients with EGFR-mutated lung cancer, then approved it as monotherapy in April 2025. In August 2026, Summit said China approved its use with chemotherapy as first-line treatment for advanced squamous lung cancer.
Summit describes ivonescimab as a bispecific antibody targeting PD-1 and VEGF-A; it was an investigational treatment in the United States. On its financial position, the company had $629.8 million in cash, cash equivalents and short-term investments as of September 30, 2026. It also announced that AstraZeneca completed a $2.0 billion strategic investment in Summit on October 5. The company expected the number of progression-free survival events required for the primary analysis in the squamous cohort of the HARMONi-3 trial to be reached during the fourth quarter of 2026, alongside a planned early interim analysis of overall survival. Summit said it intends to hold a conference call and webcast after the FDA takes action on the application, with details to be announced after the action and beforehand.