Outlook Therapeutics, Inc. (OTLK) Misled Investors About the Viability and Efficacy of its Lead Product Candidate
A shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Outlook Therapeutics, Inc. (NASDAQ: OTLK) securities between December 29, 2022 and August 29, 2023. Outlook is a late clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. The Company’s lead product candidate is ONS-5010, an ophthalmic formulation of the antibody bevacizumab for the treatment of wet age-related macular degeneration (“wet AMD”) and other retina diseases.
According to the complaint, during the class period, defendants failed to disclose that: (i) there was a lack of substantial evidence supporting ONS-5010 as a treatment for wet AMD; (ii) 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 BLA was re-submitted to the FDA; (iii) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; and (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated.
On August 30, 2023, Outlook issued a press release announcing that the FDA had issued a complete response letter (“CRL”) 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.
What Now: Similarly situated shareholders may be eligible to participate in the class action against Outlook Therapeutics, Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP. Plaintiffs must file their lead plaintiff papers by January 2, 2024. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.
All representation is on a contingency fee basis. Shareholders pay no fees or expenses.
