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FDA decision (PDUFA) — RARE (Ultragenyx) UX111
Will the FDA approve UX111 (ABEO) on/around 2026-09-19? Sanfilippo syndrome A
premise not yet verified
EHIQ
75%
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 6, 2026
Expected resolution
September 19, 2026
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