biotechResolvedNO DIRECTION

FDA decision (PDUFA) — PTGX rusfertide

Will the FDA approve rusfertide (PTGX) on/around 2026-09-30? polycythemia vera

premise not yet verified

EHIQ graded opening

50%

Market

—

gap vs market

—

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

YES

Resolved

September 5, 2026

[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] Outcome recorded: YES. FDA press announcement, For Immediate Release 2026-08-28 (https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-its-kind-polycythemia-vera-rare-blood-disorder): "Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera". The approval came about a month before the question's on/around 2026-09-30 date and after the call opened (2026-08-20). EHIQ was 50% at open, so the verdict stays NO DIRECTION (neither a hit nor a miss); recording the outcome adds the row to Brier at 0.25. hit, resolution, resolved_at and every probability are unchanged.

Opened

August 20, 2026

Expected resolution

August 28, 2026

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