The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities between December 29, 2022 and August 29, 2023, inclusive (the “Class Period”). Outlook investors have until January 2, 2024 to file a lead plaintiff motion.

If you are a shareholder who suffered a loss, click here to participate.

On August 30, 2023, Outlook disclosed that the FDA had issued a complete response letter regarding the Company’s wet age-related macular degeneration (“wet AMD”) treatment, ONS-5010. The FDA concluded that “it could not approve the [biologics license application]” due to “several [chemistry manufacturing and controls] issues, open observations from pre-approval manufacturing inspections, and lack of substantial evidence.”

On this news, Outlook’s stock price fell $1.141, or 80.9%, to close at $0.269 per share on August 30, 2023, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) there was a lack of substantial evidence supporting ONS-5010 as a treatment for wet AMD; (2) Outlook and/or its manufacturing partner had deficient chemistry manufacturing and controls and other manufacturing issues for ONS-5010, which remained unresolved at the time the ONS-5010 BLA was resubmitted 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, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

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If you purchased Outlook securities during the Class Period, you may move the Court no later than January 2, 2024 to ask the Court to appoint you as lead plaintiff. To be a member of the Class you need not take any action at this time; you may retain counsel of your choice or take no action and remain an absent member of the Class. If you purchased Outlook securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Frank R. Cruz, of The Law Offices of Frank R. Cruz, 2121 Avenue of the Stars, Suite 800, Los Angeles, California 90067 at 310-914-5007, by email to info@frankcruzlaw.com, or visit our website at www.frankcruzlaw.com. If you inquire by email please include your mailing address, telephone number, and number of shares purchased.

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The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Outlook Therapeutics, Inc. (OTLK) Investors