Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities between December 29, 2022 and August 29, 2023, inclusive (the “Class Period”). Outlook investors have until January 2, 2024 to file a lead plaintiff motion.
Investors suffering losses on their Outlook investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to howardsmith@howardsmithlaw.com.
On August 30, 2023, Outlook disclosed that the FDA had issued a complete response letter regarding the Company’s wet age-related macular degeneration (“wet AMD”) treatment, ONS-5010. The FDA concluded that “it could not approve the [biologics license application]” due to “several [chemistry manufacturing and controls] issues, open observations from pre-approval manufacturing inspections, and lack of substantial evidence.”
On this news, Outlook’s stock price fell $1.141, or 80.9%, to close at $0.269 per share on August 30, 2023, thereby injuring investors.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) there was a lack of substantial evidence supporting ONS-5010 as a
treatment for wet AMD; (2) 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 resubmitted to the FDA; (3) as a result of all the foregoing, the FDA was unlikely to approve the ONS-5010 BLA in its present form; (4) accordingly, ONS-5010’s regulatory and commercial prospects were overstated; and (5) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.
If you purchased Outlook securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020, by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com.
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View source version on businesswire.com: https://www.businesswire.com/news/home/20231108053239/en/
Contacts
Law Offices of Howard G. Smith
Howard G. Smith, Esquire
215-638-4847
888-638-4847
howardsmith@howardsmithlaw.com
www.howardsmithlaw.com
