As of Oct 26, 2026: Summit Therapeutics (SMMT) has a PDUFA date for ivonescimab on Nov 14, 2026, in 19 days. Its Quality Score is -1. Scores as of 8:36 PM ET, 15 minutes behind.

SMMT FDA decision on Ivonescimab

Summit Therapeutics · PDUFA date

PDUFA dateNov 14in 19 days Quality Score-1Poor

Cash runway6quarters of cash

What the company said

“(BLA) with the U.S. Food and Drug Administration (FDA) is based on the results from the HARMONi trial and has a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.”

PDUFA date, Nov 14, 2026. As Summit Therapeutics stated in its 8-K of Sep 15, 2026 (the filing).

A PDUFA date is the day the FDA has said it aims to decide on a drug. The FDA can decide earlier, or extend its review, often by three months.

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