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Submit Your Information for the Outlook Therapeutics, Inc. Lawsuit

Lead plaintiff deadline is January 2, 2024.

If you purchased or acquired Outlook securities between August 3, 2021 and August 29, 2023, please contact Berger Montague using the form below.

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About the Case

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 Outlook, 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 Outlook planned to submit to the FDA in the first quarter of 2022.

The Class Period commences on December 29, 2022, when Outlook issued a press release announcing its financial results for its fiscal year 2022. In the press release, Outlook announced, “In anticipation of potential FDA marketing approval in 2023, Outlook Therapeutics has begun commercial launch planning, including best-in-class partnerships with FUJIFILM Diosynth Biotechnologies for drug substance, and with drug product manufacturer Aji Bio-pharma Services for the finished drug product.”

The truth regarding ONS-5010 emerged on August 30, 2023, when Outlook issued a press release announcing that the FDA had issued a complete response letter (“CRL”) to the ONS-5010 BLA and could not approve the ONS-5010 BLA during the present review cycle because of unresolved chemistry manufacturing and controls (“CMC”) and manufacturing site inspection issues, as well as “a lack of substantial evidence.”

Following 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.

According to the complaint and throughout the Class Period, the defendants failed to disclose to investors 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 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; and (iv) accordingly, ONS-5010’s regulatory and commercial prospects were overstated.

Investors who purchased or acquired Outlook securities between August 3, 2021 and August 29, 2023, may no later than January 2, 2024, seek to be appointed as a lead plaintiff representative of the class.