Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye Disease [Yahoo! Finance]
Aldeyra Therapeutics, Inc. (ALDX)
Last aldeyra therapeutics, inc. earnings: 11/7 07:00 am
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Source: Yahoo! Finance
discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye disease. The extended PDUFA target action date is March 16, 2026. Following submission on June 16, 2025, the NDA was accepted for review as a "complete class 2 response" by the FDA on July 16, 2025, with a target PDUFA action date of December 16, 2025. On December 12, 2025, the FDA met with Aldeyra to request submission to the NDA of the Clinical Study Report (CSR) for the dry eye disease field trial of reproxalap, for which top-line results were announced on May 5, 2025. The field trial, which was supportive of the activity of reproxalap relative to vehicle, did not meet the primary endpoint of improvement in dry eye symptoms relative to the vehicle control. Prior to submitting th
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News
- Aldeyra Therapeutics Announces PDUFA Extension of the New Drug Application of Reproxalap for the Treatment of Dry Eye DiseaseBusiness Wire
- Aldeyra Therapeutics, Inc. (ALDX) Discusses Expansion of RASP Platform Into CNS Diseases and Update on Reproxalap for Dry Eye Transcript [Seeking Alpha]Seeking Alpha
- Aldeyra Therapeutics Announces Expansion of RASP Platform to Include Central Nervous System Diseases and Provides Updates on Reproxalap at Research & Development Webcast [Yahoo! Finance]Yahoo! Finance
- Aldeyra Therapeutics Announces Expansion of RASP Platform to Include Central Nervous System Diseases and Provides Updates on Reproxalap at Research & Development WebcastBusiness Wire
- Aldeyra Therapeutics to Participate in the Jefferies Global Healthcare Conference in LondonBusiness Wire
ALDX
Earnings
- 11/5/25 - Beat
ALDX
Sec Filings
- 12/16/25 - Form 8-K
- 11/14/25 - Form SCHEDULE
- 11/13/25 - Form 8-K
- ALDX's page on the SEC website