Outlook Therapeutics, Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of New Jersey on behalf of those who acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities during the period from August 3, 2021 through August 29, 2023, inclusive (the “Class Period”). Investors have until January 2, 2024 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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, 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.
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.
On August 30, 2023, Outlook announced that the FDA had issued a complete response letter to the ONS-5010 BLA. The Company advised that the FDA could not approve the BLA during this review cycle due to several issues. On this news, the price of Outlook shares declined by $1.141 per share, or approximately 80.92%, from $1.41 per share to close at $0.269 on August 30, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as 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 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.
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, 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.
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.
On August 30, 2023, Outlook announced that the FDA had issued a complete response letter to the ONS-5010 BLA. The Company advised that the FDA could not approve the BLA during this review cycle due to several issues. On this news, the price of Outlook shares declined by $1.141 per share, or approximately 80.92%, from $1.41 per share to close at $0.269 on August 30, 2023.
The lawsuit alleges that, throughout the Class Period, Defendants made false and/or misleading statements, as well as 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 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.