Philadelphia, Pennsylvania--(Newsfile Corp. - December 23, 2023) - Berger Montague informs investors that the firm has filed a securities class action lawsuit in the United States District Court for the District of New Jersey against Outlook Therapeutics, Inc. ("Outlook") (NASDAQ: OTLK). This action is captioned Maniatty v. Outlook Therapeutics, Inc., et al., Case No. 2:23-cv-23313 (the "Maniatty Action") and is brought on behalf of investors who purchased Outlook common stock between August 3, 2021 and August 29, 2023, inclusive (the "Class Period").
There is a related class action pending against Outlook in the same jurisdiction. The first-filed action issued a notice of its filing pursuant to the federal securities laws, which triggered the deadline of January 2, 2024, for any investors who purchased Outlook common stock to seek to be appointed as a lead plaintiff representative of the class. The filing of the Maniatty Action does not change the January 2, 2024 lead plaintiff deadline.
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The truth regarding ONS-5010 began to emerge on May 31, 2022, when the Company announced that it had voluntarily withdrawn the BLA for ONS-5010 in order to provide additional information requested by the FDA. Outlook acknowledged that it was "actively working to respond to the FDA's request" and that it planned to resubmit a "revised BLA" later in the year.
Following this news, Outlook's stock price fell $0.54 per share, or nearly 32%, from a closing price of $1.69 per share on May 27, 2022 to a closing price of $1.15 on May 31, 2022, the next trading day.
Then, on August 30, 2023, Outlook issued a press release announcing that the FDA had issued a complete response letter 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.
Investors who purchased or acquired Outlook common stock 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 jmaro@bm.net or (215) 875-3093, or Andrew Abramowitz at aabramowitz@bm.net or (215) 875-3015.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. 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, Washington, D.C., and San Diego, 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.
Contacts:
James Maro, Senior Counsel
Berger Montague
(215) 875-3093
jmaro@bm.net
Andrew Abramowitz, Senior Counsel
Berger Montague
(215) 875-3015
aabramowitz@bm.net
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/192235
