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Aldeyra Therapeutics is a biotech firm developing immune-modulating medicines like reproxalap for ocular and systemic diseases, with multiple products in clinical trials for conditions such as dry eye, psoriasis, asthma, COVID-19, and retinal diso...
Reproxalap, Aldeyra's lead investigational small-molecule targeting RASP, is being developed for dry eye disease and allergic conjunctivitis, with a New Drug Application under review by the FDA.
The U.S. Food and Drug Administration (FDA) extended the review period for Aldeyra's New Drug Application (NDA) for its dry eye disease drug, reproxalap, to March 16, 2026. The extension was due to the submission of a Clinical Study Report, which the FDA considered a major amendment; however, the agency did not identify any new issues with the application and had previously shared a draft label with the company, leading to a positive market reaction.
Aldeyra Therapeutics announced a strategic expansion of its proprietary RASP (reactive aldehyde species) modulator platform to include the development of treatments for central nervous system (CNS) diseases. This move into a new therapeutic area is based on promising preclinical results for its next-generation RASP modulator, ADX-248, in models of neuroinflammatory diseases.
Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) shares are trading higher on Tuesday as investors react to the company's intent to submit a formal dispute resolution request tied to its reproxalap program.
Aldeyra Therapeutics, Inc. (ALDX) Discusses FDRR and FDA Review Process for Reproxalap in Dry Eye Disease Transcript
Aldeyra Therapeutics NASDAQ: ALDX said it plans to submit a formal dispute resolution request, or FDRR, to the FDA's Office of New Drugs seeking review of the agency's latest complete response letter for reproxalap, its investigational treatment for the signs and symptoms of dry eye disease.
CONCORD, Mass.--(BUSINESS WIRE)--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced intent to submit to the U.S. Food and Drug Administration (FDA) a Formal Dispute Resolution Request (FDRR) for reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The FDRR, which is expected to be reviewed by the FDA's Office of New Drug.
Overall rating: C
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