Outlook Therapeutics, Inc.

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.