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ALDX Aldeyra Therapeutics News Story

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Aldeyra plunges after FDA declines to approve experimental dry eye drug

** Shares of biotech firm Aldeyra Therapeutics ALDX.O fall 74% to $1.12 premarket

** Co says the FDA declined to approve its application for experimental dry eye drug, reproxalap, citing lack of reliable evidence it works

** FDA in its so-called complete response letter flagged inconsistent results across trials and said studies did not clearly show benefit on signs and symptoms - ALDX

** Agency found no safety or manufacturing issues, but advised ALDX to analyze failed trials and patient subgroups, co says

** Co says it will not run new trials and plans to seek a meeting with the FDA to discuss next steps

** Dry eye disease is a common condition where the eyes do not make enough tears or the right quality of tears, causing irritation and blurred vision

** Shares up ~4% in 2025

 (Reporting by Sahil Pandey in Bengaluru)

 ((Sahil.Pandey@thomsonreuters.com))

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