Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) stock is plummeting 74 percent in pre-market trading subsequent to FDA issues Complete Response Letter.
Aldeyra Therapeutics has received a Complete Response Letter from the U.S. Food and Drug Administration regarding its New Drug Application for reproxalap, a treatment for dry eye disease.
The FDA cited insufficient evidence of efficacy as the reason for the letter. The regulatory body did not request additional clinical trials but recommended further investigation into the reasons behind trial failures and identifying potentially effective patient populations.
Aldeyra plans to request a meeting with the FDA to discuss the next steps. The company reported having $70 million in cash and equivalents as of December 2025.
Aldeyra Therapeutics was changing hands near $1.09 in pre-market trading after closing at $4.23.
 stock is jumping 74 in pre-market trading subsequent to FDA issues Complete Response Letter.){kind=link}