Aldeyra: FDA extends reproxalap PDUFA to March 16, 2026 after requesting failed trial report

Aldeyra Therapeutics, Inc.

PDUFA target action date extended three months to March 16, 2026 from original Dec 16, 2025.
FDA requested CSR of dry eye field trial that missed primary endpoint; CSR submitted Dec 12 as major amendment.
FDA shared draft label in early December; Aldeyra responded; labeling and postmarketing plans expected by Feb 16, 2026.
No other specific issues or requests identified by FDA during review.
Field trial top-line results announced May 5, 2025; safety data previously submitted Aug 21, 2025.

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