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biotechResolvedHit

FDA decision (PDUFA) — NUVL zidesamtinib

Will the FDA approve zidesamtinib (NUVL) on/around 2026-09-18? ROS1 NSCLC

premise not yet verified
EHIQ
50%
Market
Edge

Thesis

AUTO-SOURCED from the FDA catalyst calendar. NEEDS CALIBRATION before it goes to subscribers: set the EHIQ probability from endpoint quality (hard vs surrogate), trial design (RCT vs single-arm), and any prior CRL, then set digest_excluded=false. Placeholder prob 0.50 = max uncertainty.

Resolution

Outcome
Resolved
September 5, 2026
Opened
August 6, 2026
Expected resolution
July 22, 2026

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