Aldeyra Therapeutics Announces PDUFA Extension for Reproxalap NDA
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Aldeyra Therapeutics announced that the FDA has extended the PDUFA date for the reproxalap NDA to March 16, 2026. The FDA requested a Clinical Study Report, and the reproxalap field trial did not meet its primary endpoint. The FDA plans to discuss labeling by February 16, 2026. A conference call is scheduled for December 16, 2025.
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