SMMT biotech catalysts & pipeline

SUMMIT THERAPEUTICS INC · Data as of 2026-09-08

Upcoming catalysts

ivonescimab — Interim data

H2 2026

The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis.

Source filing

ivonescimab — PDUFA

Nov 14

Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026.

Source filing

ivonescimab — Topline data

H1 2027

For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.

Source filing

ivonescimab — Initial data

mid-2027

Data from the study under this collaboration agreement is expected to be generated by mid-2027.

Source filing

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