Outlook Therapeutics, Inc.
|Company Name||Outlook Therapeutics, Inc.|
|Class Period||December 29, 2022 to August 29, 2023|
|Lead Plaintiff Motion Deadline||January 02, 2024|
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.
Submit Your Information
If you suffered a loss on your Outlook Therapeutics, Inc. investments or would like to inquire about joining an action to recover your loss under the federal securities laws, please complete the form below. Please note that submission of this form does not by itself form an attorney-client relationship nor does filing out this form mean you have joined any lawsuit.