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FDA decision (PDUFA) — CAPR deramiocel

Will the FDA approve deramiocel (CAPR) on/around 2026-08-22? DMD (AdComm Jul 29)

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.
Opened
August 13, 2026
Expected resolution
August 22, 2026