Aldeyra Therapeutics, Inc.
Securities Class Action

On March 17, 2026, Aldeyra issued a press release “announc[ing] 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.” According to Aldeyra’s press release, “[t]he 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 concerns about the reliability and meaningfulness of the positive findings’ and that the ‘totality of evidence from the completed clinical trials does not support the effectiveness of the product.’” On this news, Aldeyra’s stock price fell $2.99 per share, or 70.69%, to close at $1.24 per share on March 17, 2026.