ALDX Aldeyra Therapeutics, Inc.

0.9586USD+4.66%Mkt Cap: 57.83M $P/E: —

Aldeyra Therapeutics, Inc., a biotechnology company, discovers and develops therapies designed to treat immune-mediated diseases. Its lead product candidate is reproxalap, a reactive aldehyde species (RASP) modulator, wh…

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Aldeyra to Appeal FDA Rejection of Reproxalap for Dry Eye Disease

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. The c

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Aldeyra Therapeutics Plans Formal FDA Dispute Resolution Request for Reproxalap After Third Complete Response Letter

Aldeyra Therapeutics intends to formally challenge the FDA’s March 2026 rejection of reproxalap for dry eye disease, with a Formal Dispute Resolution Request and meeting with the agency’s Office of New Drugs expected in the fourth quarter of 2026. Key Investor TakeawaysAldeyra Therapeutics (NASDAQ:ALDX) plans to submit a Formal Dispute Resolution Request seeking to appeal the FDA’s March 16, 2026 Complete Response Letter for reproxalap.

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