OUTLOOK INVESTOR DEADLINE APPROACHING

Rhea-AI Summary

Outlook Therapeutics, Inc. (NASDAQ: OTLK) Faces Securities Class Action Lawsuit Due to FDA Issues with Lead Product Candidate

Positive

• The securities class action lawsuit against Outlook Therapeutics, Inc. (NASDAQ: OTLK) highlights the FDA's concerns regarding the company's lead product candidate, ONS-5010, for the treatment of wet age-related macular degeneration.
• The lawsuit alleges that the company and its executives violated federal securities laws by making false and/or misleading statements and/or failing to disclose manufacturing issues and a lack of substantial evidence supporting ONS-5010's regulatory approval.
• The press release from Outlook on August 30, 2023, announcing the FDA's complete response letter to the ONS-5010 BLA, resulted in an 80.92% decrease in the company's stock price, closing at $0.269 per share.
• Investors who suffered losses in Outlook between December 29, 2022, and August 29, 2023, are encouraged to contact Faruqi & Faruqi partner Josh Wilson directly to discuss their legal rights.

Negative

• None.

Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Outlook To Contact Him Directly To Discuss Their Options

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.

There is no cost or obligation to you.

NEW YORK, Nov. 13, 2023 /PRNewswire/ -- 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.

Attorney Advertising. The law firm responsible for this advertisement is Faruqi & Faruqi, LLP (www.faruqilaw.com). Prior results do not guarantee or predict a similar outcome with respect to any future matter. We welcome the opportunity to discuss your particular case. All communications will be treated in a confidential manner.

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SOURCE Faruqi & Faruqi, LLP

FAQ

What is the ticker symbol of Outlook Therapeutics, Inc.?

The ticker symbol of Outlook Therapeutics, Inc. is OTLK.

What were the allegations against Outlook Therapeutics, Inc.?

The allegations include the company and its executives violating federal securities laws by making false and/or misleading statements and/or failing to disclose manufacturing issues and a lack of substantial evidence supporting ONS-5010's regulatory approval.

What was the impact of the FDA's complete response letter on Outlook's stock price?

The FDA's complete response letter to the ONS-5010 BLA resulted in an 80.92% decrease in Outlook's stock price, closing at $0.269 per share.

How can investors who suffered losses in Outlook contact Faruqi & Faruqi?

Investors who suffered losses in Outlook between December 29, 2022, and August 29, 2023, are encouraged to contact Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310) to discuss their legal rights.