FDA decision (PDUFA) — NUVL zidesamtinib

Resolution

[2026-10-16 eric-stamp KN] Labelled no-direction: EHIQ's graded at-open probability was exactly 0.50, which has no direction, so this call is neither a hit nor a miss. The stored hit column, actual_outcome and every probability are unchanged; ties stay in the hit-rate denominator (SCORING_POLICY §5). [2026-10-18 eric-stamp QAU-D4] VOID — defective at registration. The FDA approved zidesamtinib (Jideytro, Nuvalent) on 2026-07-22 (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer): "On July 22, 2026, the Food and Drug Administration approved zidesamtinib". This call was opened on 2026-08-06, after the approval, so its outcome was already known when it was registered. Voided rather than graded, following the #88 convention (resolution 'void', hit NULL): it counts as neither a hit nor a miss and leaves the scoreboard population. Prior label: 'Outcome per resolution_source. EHIQ 50% at open (no directional edge): neither a hit nor a miss. Prior label: 'hit'.'; prior hit: true. actual_outcome (NULL), resolved_at and every probability are unchanged.