Overview

A class action lawsuit captioned Alsaidi v. Outlook Therapeutics, Inc., et al. has been filed against Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) and certain of the Company’s top executive officers alleging that they violated the federal securities laws.  The lawsuit seeks to represent all persons and entities who purchased or otherwise acquired Outlook securities between December 29, 2022, and August 29, 2023, both dates inclusive (the “Class Period”).

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.

As alleged in the lawsuit, In August 2021, Outlook announced the topline readout of data from its pivotal Phase 3 NORSE TWO trial of ONS-5010 for the treatment of wet AMD. According to the Company, this data, among other things, “demonstrated clinically relevant and highly statistically significant results” that supported the submission of a biologics license application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for ONS-5010 for the treatment of wet AMD (the “ONS-5010 BLA”), which the Company planned to submit to the FDA in the first quarter of 2022.

In March 2022, Outlook announced that it had submitted the ONS-5010 BLA to the FDA. Thereafter, in May 2022, the Company voluntarily withdrew the ONS-5010 BLA to provide additional information requested by the FDA. Following receipt of further correspondence from the FDA, the Company purportedly “confirmed the additional information necessary to re-submit the BLA for ONS-5010” and resubmitted the BLA in August 2022.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or 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; (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated; and (v) 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.

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If you purchased or otherwise acquired Outlook securities between December 29, 2022 and August 29, 2023, both dates inclusive, and suffered substantial losses, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the Outlook lawsuit is January 02, 2024.