Aldeyra Therapeutics Receives Complete Response Letter from the U.S. Food and Drug Administration for the Reproxalap New Drug Application for the Treatment of Signs and Symptoms of Dry Eye...
Aldeyra Therapeutics, Inc. (ALDX)
Last aldeyra therapeutics, inc. earnings: 11/7 07:00 am
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Source: Yahoo! Finance
LEXINGTON, Mass., March 17, 2026 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 receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. The CRL stated that there is "a lack of substantial evidence consisting of adequate and well-controlled investigations … that the drug product will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in its proposed labeling" and that "the application has failed to demonstrate efficacy in adequate and well controlled studies in the treatment of signs and symptoms of dry eye disease." The letter also stated that the "inconsistency of study results raises serious co
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News
- ALDX Investor Alert: Aldeyra Therapeutics, Inc. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Management Allegedly Misrepresented Drug Efficacy And Approval Prospects: Levi & KorsinskyGlobeNewswire
- ALDX Investor Alert: Aldeyra Therapeutics, Inc. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Management Allegedly Misrepresented Drug Efficacy And Approval Prospects: Levi & KorsinskyPR Newswire
- ALDX Crashes 71% as FDA Issues Third CRL for Dry Eye Disease Drug NDA [Yahoo! Finance]Yahoo! Finance
- Aldeyra Therapeutics (ALDX) had its "neutral" rating reaffirmed by HC Wainwright. They now have a $2.00 price target on the stock, down from $10.00.MarketBeat
- FDA issues CRL to Aldeyra's reproxalap drug application [Yahoo! Finance]Yahoo! Finance
ALDX
Earnings
- 11/5/25 - Beat
ALDX
Sec Filings
- 3/17/26 - Form 8-K
- 2/27/26 - Form S-8
- 2/27/26 - Form 10-K
- ALDX's page on the SEC website