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biotechResolvedHit
FDA decision (PDUFA) — RARE DTX401 gene therapy
Will the FDA approve DTX401 gene therapy (RARE) on/around 2026-08-23? glycogen storage disease Ia
premise not yet verified
EHIQ
50%
Market
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Edge
—
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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
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Resolved
September 1, 2026
Opened
July 18, 2026
Expected resolution
August 23, 2026
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