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Aldeyra Therapeutics, Inc. (ALDX) Shareholder Notice: Robbins LLP Reminds Shareholders of Class Action Filed Against Aldeyra Therapeutics, Inc.

Key Takeaway: Aldeyra Therapeutics, Inc. is facing a class action lawsuit alleging that the company misled investors about the effectiveness of its drug candidate ADX-2191. The complaint highlights that the New Drug Application submitted to the FDA lacked adequate evidence to support the drug's effectiveness. Following the FDA's issuance of a Complete Response Letter due to insufficient evidence, Aldeyra's stock price significantly decreased. Shareholders have until September 29, 2023, to file motions to act as lead plaintiffs in the class action.

Market Sentiment Analysis

CONCERNS & RISKS

  • Shareholder class action claims Aldeyra misled investors regarding drug candidate ADX-2191.
  • FDA expressed a lack of substantial evidence of effectiveness for ADX-2191, hindering approval prospects.
  • Aldeyra's stock price fell 27.44% following the Complete Response Letter from the FDA.

Full Press Release Details

SAN DIEGO, Aug. 04, 2023 (GLOBE NEWSWIRE) --
Robbins LLP reminds investors that 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.
For more information, submit a form, email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
What is this Case About: Aldeyra Therapeutics, Inc. (ALDX) Misled Investors Regarding the Viability and Efficacy of its Drug Candidate
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. For more information, click here.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
About Robbins LLP: Some law firms issuing releases about this matter do not actually litigate securities class actions; Robbins LLP does. A recognized leader in shareholder rights litigation, the attorneys and staff of Robbins LLP have been dedicated to helping shareholders recover losses, improve corporate governance structures, and hold company executives accountable for their wrongdoing since 2002. Since our inception, we have obtained over $1 billion for shareholders.
Attorney Advertising. Past results do not guarantee a similar outcome.

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#Aldeyra Therapeutics Inc.
$ALDX clinical trial

Frequently Asked Questions

What is the Aldeyra class action about?

The lawsuit claims Aldeyra misled investors about the effectiveness of ADX-2191.

What was the FDA's response to ADX-2191?

The FDA issued a Complete Response Letter citing lack of substantial evidence of effectiveness.

When is the deadline to become a lead plaintiff?

The deadline to file a motion for lead plaintiff is September 29, 2023.

What happened to Aldeyra's stock price?

Aldeyra's stock dropped 27.44% to $7.72 after the FDA's announcement.

Are shareholders required to participate in the case?

Shareholders can remain absent class members without participating in the case.

Last updated: Aug 4, 2023