Summit Therapeutics Inc.
PDUFA Confirmed
ivonescimab
EGFR-mutated locally advanced or metastatic non-squamous NSCLC post‑TKI therapy
Countdown
130days
FDA decision · Nov 14, 2026
What's at stake The FDA's approval decision on ivonescimab for EGFR-mutated locally advanced or metastatic non-squamous NSCLC post‑TKI therapy is due Nov 14, 2026. A green light opens the market; a complete response letter (CRL) usually sinks the stock.
“Based upon standard review timelines, if the application is accepted as submitted, we anticipate a decision from the agency by the fourth quarter of 2026.”

Provenance

7 sources on file.

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