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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.
CONCORD, Mass., September 29, 2026--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 Dr
CONCORD, Mass., September 28, 2026--Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the company will host a regulatory update webcast on Tuesday, September 29, 2026, at 8:00 a.m. ET. The update will focus on reproxalap, an investigational drug for the treatment of dry eye disease.
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