ALDX Crashes 71% as FDA Issues Third CRL for Dry Eye Disease Drug NDA [Yahoo! Finance]
Aldeyra Therapeutics, Inc. (ALDX)
Last aldeyra therapeutics, inc. earnings: 11/7 07:00 am
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Source: Yahoo! Finance
Shares of Aldeyra Therapeutics ALDX plunged 70.7% on Tuesday after the company announced receiving a Complete Response Letter (CRL) from the FDA for a third time for the new drug application (NDA) seeking approval of reproxalap, an investigational drug candidate, for the treatment of dry eye disease. We remind investors that ALDX initially received a CRL for its reproxalap NDA in 2023, citing that the study results supporting the filing failed to demonstrate the candidate's efficacy in treating ocular symptoms associated with dry eyes. Back then, the FDA recommended that at least one additional adequate and well-controlled study be conducted on reproxalap to demonstrate a positive effect on the treatment of ocular symptoms of dry eye. Following the setback, Aldeyra Therapeutics announced meeting the primary endpoint in a phase III dry eye chamber study later in 2024, which evaluated reproxalap for the treatment of dry eye disease. In the study, treatment with reproxalap was stati
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ALDX
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
- 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
- Aldeyra Therapeutics (ALDX) had its "buy" rating reaffirmed by BTIG Research.MarketBeat
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