NEW YORK, Jan. 31, 2021 /PRNewswire/ — Pomerantz LLP announces that a class action lawsuit has been filed against Minerva Neurosciences, Inc. (“Minerva” or the “Company”) (NASDAQ: NERV) and certain of its officers. The class action, filed in United States District Court for the District of Massachusetts, and docketed under 21-cv-10051, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired securities between May 15, 2017 and November 30, 2020, inclusive (the “Class Period”). This action is brought on behalf of the Class (as defined below) for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”), 15 U.S.C. §§ 78j(b) and 78t(a), and Rule 10b-5 promulgated thereunder by the SEC, 17 C.F.R. § 240.10b-5.
If you are a shareholder who purchased Minerva securities during the Class Period, you have until February 8, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Minerva purports to be a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat patients suffering from central nervous diseases. The Company's lead product candidate is roluperidone (also known as MIN-101).
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 15, 2017, the start of the Class Period, Minerva announced via press release that it would proceed to a Phase 3 clinical trial for MIN-101 following a successful “end-of-Phase 2” meeting with the U.S. Food and Drug Administration (“FDA”). In this press release, Defendant Rémy Luthringer (“Luthringer”) was quoted as saying that “[o]ur discussion with the [FDA] has helped to confirm our Phase 3 trial design, which is similar to our previous Phase 2b trial design. We believe that positive data from the Phase 3 trial, along with the positive data from the Phase 2b trial, may form the basis for the future submission of a New Drug Application for [roluperidone] with the FDA.”
The FDA, however, did not agree with Minerva that positive data from the Phase 2b trial could form the basis of a future New Drug Application (“NDA”) for MIN-101, or that the Phase 3 trial was a well-designed trial. Thus, Luthringer's statements about FDA feedback were materially misleading.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements, and failed to disclose material adverse facts about the Company's business, operational, and compliance policies. Specifically, Defendants made false and/or misleading statements and failed to disclose to investors that: (i) the truth about the feedback received from the FDA concerning the “end-of-Phase 2” meeting; (ii) that the Phase 2b study did not use the commercial formulation of roluperidone and was conducted solely outside of the U.S.; (iii) that 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) that 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) that 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) that, as a result, the Company's public statements were materially false and misleading at all relevant times.
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 fell 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, representing a one day drop of approximately 72.5%.
On a November 2, 2020 earnings call, Luthringer, in discussing an upcoming November 10, 2020 meeting with the FDA to discuss whether the Phase 2b study combined with the data from the Phase 3 study could form the basis of an NDA, said: “with all the data we have generated and we put in the briefing book, we are extremely confident that the FDA will understand that we have really very compelling data as you already have seen, when you combine the 2 studies, Phase IIb and Phase III . . . .”
On December 1, 2020, before the markets opened, 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, representing a one day drop of approximately 25.7%.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
888-476-6529 ext. 7980