San Diego, CA -- (SBWIRE) -- 09/11/2023 -- Outlook Therapeutics, Inc. is under investigation over potential securities laws violations in connection with certain financial statements.

Investors who purchased shares of Outlook Therapeutics, Inc. (NASDAQ: OTLK), have certain options and should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

The investigation by a law firm focuses on whether a series of statements by Outlook Therapeutics, Inc. (NASDAQ: OTLK regarding its business, its prospects and its operations were materially false and misleading at the time they were made.

Cranbury, NJ based Outlook Therapeutics, Inc., a late clinical-stage biopharmaceutical company, focuses on developing and commercializing monoclonal antibodies for various ophthalmic indications. Its lead product candidate is ONS-5010, a proprietary ophthalmic formulation of bevacizumab product candidate that is in Phase-III clinical trial for the treatment of wet age related macular degeneration and other retina diseases.

On August 30, 2023, Outlook Therapeutics, Inc. issued a press release "announc[ing] the U.S. Food and Drug Administration (FDA) has issued a CRL to the Company's BLA for ONS-5010, an investigational ophthalmic formulation of bevacizumab under development to treat wet AMD. While 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."

Shares of Outlook Therapeutics, Inc. (NASDAQ: OTLK) declined to $0.21 per share on August 31, 2023.

Those who purchased shares of Outlook Therapeutics, Inc. (NASDAQ: OTLK) have certain options and should contact the Shareholders Foundation.

Contact:
Shareholders Foundation, Inc.
Michael Daniels
3111 Camino Del Rio North - Suite 423
92108 San Diego
Phone: +1-(858)-779-1554
Fax: +1-(858)-605-5739
mail@shareholdersfoundation.com

About The Shareholders Foundation
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.