A securities class action has been filed against Aldeyra Therapeutics, Inc. (ALDX) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Aldeyra securities between March 17, 2022 through June 20, 2023. This case has been filed in the USDC – MA.

On June 21, 2023, Aldeyra issued a press release “announc[ing] receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the 505(b)(2) New Drug Application (NDA) of ADX-2191 (methotrexate for injection, USP), an investigational drug candidate, for the treatment of primary vitreoretinal lymphoma (PVRL).” The press release stated that “[a]lthough no safety or manufacturing issues with ADX-2191 were identified, the FDA stated that there was a ‘lack of substantial evidence of effectiveness’ due to ‘a lack of adequate and well-controlled investigations’ in the literature-based NDA submission.” On this news, Aldeyra’s stock price fell sharply during intraday trading on June 21, 2023.