Philadelphia, Pennsylvania--(Newsfile Corp. - November 7, 2023) - Berger Montague advises investors that a securities fraud class action lawsuit has been filed against Outlook Therapeutics, Inc. ("Outlook") (NASDAQ: OTLK) on behalf of purchasers of Outlook's securities between December 29, 2022 and August 29, 2023, inclusive (the "Class Period").
Investor Deadline: Investors who purchased or acquired Outlook securities during the Class Period may, no later than January 2, 2024, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation, please contact Berger Montague: James Maro at [email protected] or (267) 637-3176, or Andrew Abramowitz at [email protected] or (215) 875-3015 or CLICK HERE.
Outlook is a clinical-stage biopharmaceutical company that focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. Outlook'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.
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 Outlook, 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 Outlook planned to submit to the FDA in the first quarter of 2022.
The Class Period commences on December 29, 2022, when Outlook issued a press release announcing its financial results for its fiscal year 2022. In the press release, Outlook announced, "In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for the finished drug product."
The truth regarding ONS-5010 emerged on August 30, 2023, when Outlook issued a press release announcing that the FDA had issued a complete response letter ("CRL") to the ONS-5010 BLA and could not approve the ONS-5010 BLA during the present review cycle because of unresolved chemistry manufacturing and controls ("CMC") and manufacturing site inspection issues, as well as "a lack of substantial evidence."
Following 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.
According to the complaint and throughout the Class Period, the defendants failed to disclose to investors 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 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.
A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the Court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
Berger Montague, with offices in Philadelphia, Minneapolis, Delaware, Washington, D.C., San Diego, San Francisco and Chicago, has been a pioneer in securities class action litigation since its founding in 1970. Berger Montague has represented individual and institutional investors for over five decades and serves as lead counsel in courts throughout the United States.
James Maro, Senior Counsel
Andrew Abramowitz, Senior Counsel
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