Executive readout · one minute
What the filings say
- 8-K earnings release · filed Nov 4, 2026
- Summit Therapeutics reported third-quarter results ended September 30, 2026, with $629.8 million cash and investments, a $2.0 billion AstraZeneca investment, an FDA PDUFA goal action date of November 14, 2026 for ivonescimab, and a HARMONi overall-survival hazard ratio of 0.76.
- 10-Q report · filed Nov 4, 2026
- Summit Therapeutics’ ivonescimab BLA was accepted in January 2026, with an FDA action date of November 14, 2026. A June 2026 analysis showed an OS hazard ratio of 0.76 (nominal p=0.0151), but FDA requires a statistically significant OS benefit.
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