biotechResolvedHit

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

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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 17, 2026

Frozen rule: 'FDA's own action on the UX111 marketing application: the approval letter or the Drugs@FDA entry recording the action, or Abeona's 8-K disclosing the agency's decision. A CRL or a delay past the date is a NO.' — OUTCOME: FDA approved UX111 (Fayuvi) 2026-09-17, two days ahead of the 9/19 PDUFA date; 'on/around' satisfied. Full approval, first treatment for Sanfilippo A. Correction for the record: call text said (ABEO); UX111 is Ultragenyx (RARE).

Opened

August 6, 2026

Expected resolution

September 19, 2026

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