FDA Rejects Aldeyra's Dry Eye Drug For Third Time, Stock Crashes 68%

Benzinga

6 hours ago

The company received an FDA Complete Response Letter (CRL) regarding its New Drug Application for reproxalap, an investigational treatment for dry eye disease. The CRL stated that there is “a lack of ...

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Crashes 68%","media":"Benzinga","content":"<div>\n<p>The company received an FDA Complete Response Letter (CRL) regarding its New Drug Application for reproxalap, an investigational treatment for dry eye disease.\nThe CRL stated that there is “a lack of ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/03/51303684/fda-rejects-aldeyras-dry-eye-drug-for-third-time-stock-crashes-68\">Source Link</a>\n\n</div>\n","source":"benzinga_hot_news","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Rejects Aldeyra's Dry Eye Drug For Third Time, Stock Crashes 68%</title>\n<style 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margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nFDA Rejects Aldeyra's Dry Eye Drug For Third Time, Stock Crashes 68%\n</h2>\n\n<h4 class=\"meta\">\n\n\n2026-03-18 00:27 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/fda/26/03/51303684/fda-rejects-aldeyras-dry-eye-drug-for-third-time-stock-crashes-68><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>The company received an FDA Complete Response Letter (CRL) regarding its New Drug Application for reproxalap, an investigational treatment for dry eye disease.\nThe CRL stated that there is “a lack of ...</p>\n\n<a href=\"https://www.benzinga.com/news/fda/26/03/51303684/fda-rejects-aldeyras-dry-eye-drug-for-third-time-stock-crashes-68\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"LU1815336091.USD","symbol_name":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) 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and well-controlled investigations.”The CRL indicated that Aldeyra failed to provide substantial evidence demonstrating the efficacy of reproxalap in adequately controlled studies, raising significant concerns about the reliability of positive findings.The FDA did not recommend further trials but suggested exploring the reasons for the failures in certain trials and identifying specific populations where the drug may be effective.In a statement, Aldeyra’s CEO, Todd Brady, emphasized the urgency of working with the FDA to enable market access for reproxalap, viewing it as a potential breakthrough treatment for dry eye disease.As of December 31, 2025, the company reported having $70 million in cash and equivalents, expected to support operations into 202","collect":0,"end_time":0,"defaultTopTitle":"benzinga.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU1815336091.USD":"THREADNEEDLE (LUX) GLOBAL SMALLER COMPANIES \"AUP\" (USD) 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demonstrating the efficacy of reproxalap in adequately controlled studies, raising significant concerns about the reliability of positive findings.\nThe FDA did not recommend further trials but suggested exploring the reasons for the failures in certain trials and identifying specific populations where the drug may be effective.\nIn a statement, Aldeyra’s CEO, Todd Brady, emphasized the urgency of working with the FDA to enable market access for reproxalap, viewing it as a potential breakthrough treatment for dry eye disease.\nAs of December 31, 2025, the company reported having $70 million in cash and equivalents, expected to support operations into 2028.\nAfter the company submitted the NDA on June 16, the FDA accepted it for review as a “complete class 2 response” on July 16, 2025, and set a target PDUFA action date of December 16.\nThe FDA extended the Prescription Drug User Fee Act (PDUFA) target action date (decision date) for reproxalap to March 16, 2026.\nIn April 2025, the FDA issued a Complete Response Letter for Aldeyra’s resubmission of the reproxalap application.\nIn November 2023, the FDA issued a Complete Response Letter to the initial NDA stating that at least one additional symptom trial was required.\nALDX Price Action: Aldeyra Therapeutics shares were down 68.61% at $1.32 at the time of publication on Tuesday. The stock is near its 52-week low of $1.13, according to Benzinga Pro data.\nImage via Shutterstock\nTo add Benzinga News as your preferred source on Google, click here.","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-2","news_tag":"productRelease","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"}}}