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Summit HARMONi OS data boost ivonescimab; FDA date on track

Jul 22, 2026, 6:36 AM EDT2 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Positive OS signal across populations, FDA BLA filing accepted, and imminent PDUFA milestone create a clear near-term pricing catalyst; ongoing trial success supports longer-term upside.

AI summary

What happened, with direct paths to the underlying reporting

Summit reported updated global HARMONi OS analyses for ivonescimab in EGFR-mut NSCLC after third-gen TKIs. Western HR 0.76 aligns with Asian results, boosting OS signal. FDA accepted the BLA with a 11/14/2026 PDUFA date, underscoring potential near- to mid-term regulatory and commercial upside for SMMT.

Global HARMONi OS analysis: Western HR 0.76; aligns with Asia.
FDA accepted BLA for ivonescimab; PDUFA date set for Nov 14, 2026.
April 2025 OS analysis: HR 0.79; median OS 16.8 vs 14.0 months.
June 2026 data cut: ITT and Western HR 0.76; Western follow-up 23.2 months.

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