NEW YORK, Dec. 10, 2020 /PRNewswire/ -- Bernstein Liebhard, a nationally acclaimed investor rights law firm, announces that a securities class action lawsuit has been filed on behalf of investors who purchased or acquired the securities of Minerva Neurosciences, Inc. ("Minerva" or the "Company") (NASDAQ: NERV) from May 15, 2017 through November 30, 2020 (the "Class Period"). The lawsuit filed in the United States District Court for the District of Massachusetts alleges violations of the Securities Exchange Act of 1934.
The complaint alleges that throughout the Class Period, 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
On December 1, 2020, Minerva issued a press release in which the Company announced the outcome of tis Type C Meeting with the FDA concerning roluperidone. In the announcement, Minerva stated that it had "received official meeting minutes from the November 10, 2020 Type C meeting with the" FDA. In this release, 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.
If you wish to serve as lead plaintiff, you must move the Court no later than February 8, 2021. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation. Your ability to share in any recovery doesn't require that you serve as lead plaintiff. If you choose to take no action, you may remain an absent class member.
Since 1993, Bernstein Liebhard LLP has recovered over $3.5 billion for its clients. In addition to representing individual investors, the Firm has been retained by some of the largest public and private pension funds in the country to monitor their assets and pursue litigation on their behalf. As a result of its success litigating hundreds of lawsuits and class actions, the Firm has been named to The National Law Journal's "Plaintiffs' Hot List" thirteen times and listed in The Legal 500 for ten consecutive years.