OUTLOOK THERAPEUTICS, INC. – Twersky Law Group, a highly regarded and reputable law firm based in New York, wishes to inform investors about a significant development in the form of a class action lawsuit against Outlook Therapeutics Inc. (“Outlook” or “the Company”) (NASDAQ: BCLI) and certain officers of the company. This lawsuit has been filed on behalf of all individuals and entities that purchased or otherwise acquired Outlook securities December 29, 2022 through August 29, 2023 (the “Class Period”). Investors who acquired Outlook securities during this defined timeframe are strongly encouraged to participate in this case by contacting atara@twerskylawgroup.com. The deadline to file a motion for appointment of lead plaintiff is January 2, 2024.
The fundamental objective of this class action lawsuit is to recover for the benefit of investors who purchased Outlook securities during the Class Period, the losses they sustained as a consequence of the misleading statements made by Defendants in violation of the federal securities laws.
ALLEGATIONS AGAINST OUTLOOK THERAPEUTICS, INC.
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. 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.
ABOUT OUTLOOK THERAPEUTICS, INC.
- Outlook Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing monoclonal antibody-based treatments for various eye diseases. Specifically, the company was working on ophthalmic indications, such as wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and branch retinal vein occlusion (BRVO).
- Outlook Therapeutics’ lead product candidate was ONS-5010, which is a bevacizumab biosimilar. Bevacizumab is a monoclonal antibody used in the treatment of various eye conditions, including wet AMD. The company was working on gaining regulatory approval for ONS-5010 to provide an alternative and potentially more cost-effective treatment option for patients suffering from these eye diseases.
JOIN THIS CASE
It is important to note that a class action lawsuit has already been filed in connection with these allegations. Therefore, for those individuals who suffered financial losses in their investments in Outlook during the Class Period, there is a limited opportunity to seek appointment as a lead plaintiff. This process entails requesting the Court to designate them as the primary representative on behalf of the entire class. The deadline for submitting such a request is January 2, 2023. It is important to emphasize that while becoming a lead plaintiff can offer certain advantages, participation in the recovery process and the potential for financial compensation does not mandate serving as a lead plaintiff.
Twersky Law Group, a distinguished legal firm renowned for its attorneys expertise in handling securities fraud class actions and shareholder derivative suits, who have a long-standing track record of successfully recovering significant sums of money for investors nationwide. With an unwavering commitment to seeking justice for their clients, the firm’s attorneys are resolute in pursuing fair compensation on behalf of those affected by alleged securities law violations. As with any legal matter, it is essential to understand that this announcement constitutes attorney advertising. Past case outcomes and results achieved do not guarantee similar outcomes in this particular case.
Investors who believe they may qualify as potential class members in the class action lawsuit against Outlook are strongly encouraged to reach out directly to the firm for further information and assistance. The knowledgeable legal professionals at Twersky Law Group stand ready to provide guidance and support to investors seeking to protect their rights and pursue the recovery they deserve.
