Aldeyra Therapeutics' Reproxalap Faces FDA PDUFA Extension to March 16, 2026 After Third Review Delay, Sparking Stock Concerns
The FDA extended the PDUFA target action date for Aldeyra's reproxalap NDA from December 16, 2025, to March 16, 2026, after requesting a Clinical Study Report (CSR) for a failed field trial on December 12, 2025.12
Reproxalap, a dry eye disease candidate, has faced two prior Complete Response Letters (CRLs):
first in November 2023 and second in April 2025, both citing insufficient efficacy data despite no safety or manufacturing issues.12
Aldeyra had prior FDA agreement not to include the failed field trial in the NDA, but the Office of Specialty Medicine required its submission, delaying review.1
A successful phase 3 dry eye chamber trial met its primary endpoint in May 2025, supporting the third NDA resubmission accepted by FDA in July 2025.12
AbbVie's exclusive option for reproxalap remains unaffected; approval would trigger a $100 million milestone payment.1
The March 16, 2026 PDUFA date is approaching, with potential approval or further issues impacting Aldeyra's stock amid history of rejections.45
Sources:
1. https://www.fiercebiotech.com/biotech/aldeyra-dry-eye-disease-candidate-hit-fda-delay-after-shifting-agency-guidance-company-says
2. https://www.ophthalmologytimes.com/view/fda-extends-aldeyra-s-reproxalap-pdufa-after-requesting-additional-clinical-study-report
4. https://www.statnews.com/2026/03/12/aldeyra-therapeutics-vertex-sarepta-therapeutics/