NEW YORK, Nov. 16, 2023 (GLOBE NEWSWIRE) -- Kaplan Fox & Kilsheimer LLP reminds investors that a complaint has been filed on behalf of investors that purchased or otherwise acquired Outlook Therapeutics, Inc. (“Outlook” or the “Company”) (NASDAQ: OTLK) securities between December 29, 2022 and August 29, 2023, inclusive (the “Class Period”). Click Here to Join Investigation.
If you acquired Outlook securities during the Class Period and would like to discuss this case, please click here. You may also contact us by emailing pmayer@kaplanfox.com or calling (646) 315-9003.
If you are a member of the proposed Class, you may move the court no later than January 2, 2024 to serve as a lead plaintiff for the purported class. If you have losses, we encourage you to contact us to learn more about the lead plaintiff process.
According to the complaint, 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.
Then, according to the complaint, 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.
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. 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."
Following this news, Outlook's stock price fell $1.141 per share, over 80%, to close at $0.269 per share on August 30, 2023.
The Complaint alleges that, throughout the Class Period, Defendants made materially false and 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.
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If you have any questions about this Notice, your rights, or your interests, please contact:
Pamela Mayer
KAPLAN FOX & KILSHEIMER LLP
800 Third Avenue, 38th Floor
New York, New York 10022
(646) 315-9003
E-mail: pmayer@kaplanfox.com
Laurence D. King
KAPLAN FOX & KILSHEIMER LLP
1999 Harrison Street, Suite 1560
Oakland, California 94612
(415) 772-4704
Fax: (415) 772-4707
E-mail: lking@kaplanfox.com
