Summit Therapeutics (SMMT) announced on Monday that it has submitted a marketing application to the US Food and Drug Administration, seeking approval for its experimental drug, ivonescimab, in combination with chemotherapy for the second-line or later treatment of certain patients with a type of non-small cell lung cancer.
The company said the submission is based on results from a phase III trial.
If the application is accepted under standard review timelines, Summit said it expects an FDA decision in Q4.
As of December 31, 2025, Summit stated that its preliminary unaudited cash, cash equivalents, and short-term investments totaled approximately $710 million, pending completion of financial closing procedures.
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