Aldeyra Fights Back Against FDA Rejection, Dispute Plan Triggers Rally

Aldeyra Therapeutics, Inc. (NASDAQ:ALDX) shares are trading higher on Tuesday as investors react to the company’s intent to submit a formal dispute resolution request tied to its reproxalap program. • ALCX stock is holding steady today. Where is ALCX stock headed? ALDX Jumps on FDA Dispute Plan for Reproxalap Aldeyra said it plans to submit a formal dispute resolution request to the FDA related to reproxalap for dry eye disease, a move that can shape the regulatory path and timeline for its lead late-stage asset. In March, the company received an FDA Complete Response Letter (CRL) regarding its New Drug Application for reproxalap, an investigational treatment for dry eye disease. FDA Cites Lack of Evidence The CRL stated that there is "a lack of substantial evidence consisting of adequate 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. With market breadth weak (only one of 11 sectors advancing), the outsized move suggests traders are treating the update as company-specific rather than a "sector tape" story. Read Also: Bausch + Lomb Advances Two Eye Therapies With Blockbuster Sales Potential ALDX Technical Analysis and Chart Setup Health Care has been soft over the past 30 days (down 0.51%) but remains higher over the last 90 days (up 6.35%). Today’s divergence looks less like a broad rotation into Health Care and more like a single-name reaction to the regulatory dispute-resolution headline. ALDX Price Action: Aldeyra Therapeutics shares were up 13.79% to $1.32 at the time of publication on Tuesday, according to Benzinga Pro data. Image via Shutterstock Read Also: Bitcoin Plummeted After the Last 4 Midterm Elections: Will History Repeat?