NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that a class action lawsuit has been filed in the United States District Court for the District of Massachusetts on behalf of investors that purchased Minerva Neurosciences, Inc. (NASDAQ: NERV) common stock between May 5, 2017 and November 30, 2020 (the “Class Period”). Investors have until February 8, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Minerva’s drug candidate roluperidone, MIN-101, is in development for the treatment of negative symptoms in patients with schizophrenia. In October 2016, the Company had previously reported positive results from a Phase 2b trial of roluperidone for this treatment, asserting that the “[d]ata show continuous improvement in negative symptoms, stable positive symptoms and extended safety profile.”
On May 29, 2020, Minerva released the results of its Phase 3 clinical trial. The Company announced that the studied “doses were not statistically significantly different from placebo at Week 12 on the primary endpoint . . . or the key secondary endpoint.” In other words, the Phase 3 clinical trial failed.
On this news, the Company’s stock price plummeted from a May 28, 2020 closing price of $13.47 per share to a May 29, 2020 closing price of just $3.71 per share.
On December 1, 2020, Minerva issued a press release revealing that it had “received official meeting minutes from the November 10, 2020 Type C meeting with the” FDA. Minerva disclosed for the first time that the “FDA advised that the Phase 2b study is problematic because it did not use the commercial formulation of roluperidone and was conducted solely outside of the United States. In addition, FDA commented that the Phase 3 study does not appear to be capable of supporting substantial evidence of effectiveness . . . .” Indeed, the “FDA cautioned that an NDA submission based on the current data from the Phase 2b and Phase 3 studies would be highly unlikely to be filed and that at a minimum, there would be substantial review issues due to the lack of two adequate and well-controlled trials to support efficacy claims for this indication.”
On this news, Minerva’s stock price fell from its November 30, 2020 closing price of $3.89 per share to a December 1, 2020 closing price of $2.89 per share. This represents a one day drop of approximately 25.7%.
The complaint, filed on December 8, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements regarding the Company’s business. Specifically, defendants made false and/or misleading statements and/or failed to disclose that: (i) the truth about the feedback received from the FDA concerning the “end-of-Phase 2” meeting; (ii) the Phase 2b study did not use the commercial formulation of roluperidone and was conducted solely outside of the United States; (iii) the failure of the Phase 3 study to meet its primary and key secondary endpoints rendered that study incapable of supporting substantial evidence of effectiveness; (iv) the Company’s plan to use the combination of the Phase 2b and Phase 3 studies would be “highly unlikely” to support the submission of an NDA; (v) reliance on these two trials in the submission of an NDA would lead to “substantial review issues” because the trials were inadequate and not well-controlled; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.
If you purchased Minerva common stock during the Class Period and suffered a loss, are a long-term stockholder, have information, 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 Brandon Walker, Melissa Fortunato, or Marion Passmore by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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