If you purchased or acquired securities in Outlook between December 29, 2022 and August 29, 2023 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). You may also click here for additional information: www.faruqilaw.com/OTLK.
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NEW YORK, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and reminds investors of the January 2, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.
Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
As detailed below, the complaint alleges that the Company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose that: (1) there was a lack of substantial evidence supporting the Company’s lead product candidate ONS-5010, an ophthalmic formulation of the antibody bevacizumab for the treatment for wet age-related macular degeneration (“wet AMD”); (2) 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 biologic license application (“BLA”) was re-submitted to the FDA; (3) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; (4) accordingly, ONS-5010's regulatory and commercial prospects were overstated; and (5) as a result, the Company's public statements were materially false and misleading at all relevant times.
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, "[w]hile the FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, the Agency 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.
The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may choose to do nothing and remain an absent class member. Your ability to share in any recovery is not affected by the decision to serve as a lead plaintiff or not.
Faruqi & Faruqi, LLP also encourages anyone with information regarding Outlook’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.
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