OUTLOOK THERAPEUTICS, INC. SHAREHOLDERS HAVE AN OPPORTUNITY TO RECOVER THEIR INVESTMENT LOSSES
Outlook Therapeutics, Inc.
Bernstein Liebhard LLP announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities between December 29, 2022 and August 29, 2023, inclusive. The lawsuit seeks to recover Outlook shareholders’ investment losses.
If you purchased securities in Outlook between December 29, 2022 and August 29, 2023, inclusive, and would like to discuss your legal rights and/or options, please click “Join Class Action” above.
According to the Complaint, Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. The Company’s lead product candidate is ONS-5010, an ophthalmic formulation of the antibody bevacizumab for the treatment of wet age-related macular degeneration (“wet AMD”) and other retina diseases.
Plaintiff alleges that Defendants made materially false and misleading statements throughout the Class Period. Among other things, Defendants failed to disclose to investors that: (i) there was a lack of substantial evidence supporting ONS-5010 as a treatment for wet AMD; (ii) Outlook and/or its manufacturing partner had deficient chemistry manufacturing and controls (“CMC”) and other manufacturing issues for ONS-5010, which remained unresolved at the time the ONS-5010 biologics license application (“BLA”) was resubmitted to the FDA; (iii) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; and (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated.
On August 30, 2023, Outlook issued a press release announcing that the FDA had issued a complete response letter to the ONS-5010 BLA. The Company advised that while the FDA acknowledged Outlook’s pivotal trial met its safety and efficacy endpoints, the FDA concluded it could not approve the BLA during this review cycle “due to several CMC issues, open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”
On this news, Outlook’s stock price fell $1.141 per share, or 80.92%, to close at $0.269 per share on August 30, 2023.
If you wish to serve as lead plaintiff, you must move the Court no later than January 2, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn’t require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal’s “Plaintiffs’ Hot List” thirteen times and listed in The Legal 500 for sixteen consecutive years.
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