Aldeyra Therapeutics, Inc. (ALDX) Misled Investors Regarding the Viability and Efficacy of its Drug Candidate

A shareholder filed a class action on behalf of investors who purchased or otherwise acquired Aldeyra (NASDAQ: ALDX) securities between March 17, 2022 and June 20, 2023.  Aldeyra, a biotechnology company, develops and commercializes medicines for immune-mediated diseases.  The Company is currently developing ADX-2191, a dihydrofolate reductase inhibitor for the treatment of primary vitreoretinal lymphoma cancer, proliferative vitreoretinopathy, and retinitis pigmentosa, as well as rare retinal diseases characterized by inflammation and vision loss.

According to the complaint, during the class period, defendants made false and/or misleading statements and/or failed to disclose that: (i) the ADX-2191 NDA did not include adequate and well-controlled investigations and thus failed to show substantial evidence of ADX-2191’s effectiveness; (ii) as a result, the FDA was unlikely to approve the ADX-2191 NDA in its current form; and (iii) accordingly, the Company had overstated ADX-2191’s clinical and/or commercial prospects.

On June 21, 2023, Aldeyra announced "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 Company 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 $2.92 per share, or 27.44%, to close at $7.72 per share on June 21, 2023.

What Now: Similarly situated shareholders may be eligible to participate in the class action against Aldeyra Therapeutics, Inc. Shareholders who want to act as lead plaintiff for the class must file their motion with the court by September 29, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.