RARE FDA decision dates

Page updated October 23, 2026·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET

RARE has no FDA decision date ahead on the pdufa.bio calendar. 3 past decisions are on record below, each on its own page. One event, one page: past decisions never share a URL with a live catalyst.

RARE catalyst hub · full calendar

Decided

Sep 17, 2026 ✓ ApprovedFAYUVI (rebisufligene etisparvovec-hopf; UX111)Aug 19, 2026 ✓ ApprovedGENGLYCOS (pariglasgene brecaparvovec-opnr, DTX401)Jul 11, 2025 CRLUX111

Facts and dates only; not investment advice. Verify against primary FDA, SEC and company filings. pdufa.bio is not affiliated with the FDA.

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