← All calls
biotechActive

FDA decision (PDUFA) — PRAX relutrigine

Will the FDA approve relutrigine (PRAX) on/around 2026-09-27? developmental epileptic encephalopathies

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
September 27, 2026