SAN DIEGO--(BUSINESS WIRE)--Robbins Geller Rudman & Dowd LLP announces that purchasers of Minerva Neurosciences, Inc. (NASDAQ:NERV) common stock between May 15, 2017 and November 30, 2020, inclusive (the “Class Period”), have until February 8, 2021 to seek appointment as lead plaintiff in the Minerva class action lawsuit, McCoy v. Minerva Neurosciences, Inc., No. 20-cv-12176 (D. Mass.), which is assigned to Judge George A. O’Toole, Jr. The Minerva class action lawsuit charges Minerva and its Chief Executive Officer with violations of the Securities Exchange Act of 1934.
The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Minerva common stock during the Class Period to seek appointment as lead plaintiff in the Minerva class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Minerva class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Minerva class action lawsuit. An investor’s ability to share in any potential future recovery of the Minerva class action lawsuit is not dependent upon serving as lead plaintiff. If you wish to serve as lead plaintiff of the Minerva class action lawsuit or have questions concerning your rights regarding the Minerva class action lawsuit, please provide your information here or contact counsel, J.C. Sanchez of Robbins Geller, at 800/449-4900 or 619/231-1058 or via e-mail at firstname.lastname@example.org. Lead plaintiff motions for the Minerva class action lawsuit must be filed with the court no later than February 8, 2021.
Minerva is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat patients suffering from central nervous system diseases. Minerva’s lead product candidate, roluperidone (MIN-101), is in development for the treatment of negative symptoms in patients with schizophrenia. In October 2016, Minerva 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.” Thereafter, on May 15, 2017, Minerva announced that it would proceed to a Phase 3 clinical trial for roluperidone following a successful “end-of-Phase 2” meeting with the U.S. Food and Drug Administration (“FDA”). In doing so, Minerva’s Chief Executive Officer, defendant Rémy Luthringer, stated 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 [NDA] for [roluperidone] with the FDA.”
The Minerva class action lawsuit alleges that, throughout the Class Period, defendants made false and/or misleading statements and/or failed to disclose: (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 United States; (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 Minerva’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, Minerva’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, revealing that the studied “doses were not statistically significantly different from placebo at Week 12 on the primary endpoint . . . or the key secondary endpoint.” On this news, Minerva’s stock price fell nearly 73%.
Then, on December 1, 2020, Minerva revealed 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 an additional 25%, further damaging investors.
Robbins Geller Rudman & Dowd LLP is one of the world’s leading law firms representing investors in securities class action litigation. With 200 lawyers in 9 offices, Robbins Geller has obtained many of the largest securities class action recoveries in history. For seven consecutive years, ISS Securities Class Action Services has ranked the Firm in its annual SCAS Top 50 Report as one of the top law firms in the world in both amount recovered for shareholders and total number of class action settlements. Robbins Geller attorneys have helped shape the securities laws and have recovered tens of billions of dollars on behalf of aggrieved victims. Beyond securing financial recoveries for defrauded investors, Robbins Geller also specializes in implementing corporate governance reforms, helping to improve the financial markets for investors worldwide. Robbins Geller attorneys are consistently recognized by courts, professional organizations, and the media as leading lawyers in the industry. Please visit http://www.rgrdlaw.com for more information.