Minerva Neurosciences, Inc.

  • Dismissed

Investigation
12/09/2020

Initial Lawsuit
12/08/2020

Lawsuit Progression
03/05/2021

Dismissal
06/09/2021

Investigation

  • Continous Holding
    May 5, 2017 to November 30, 2020
  • Proposed Claim
    Securities Violation

Investigation regarding Minerva’s statements about its Phase 2b & Phase 3 trials of MIN-101 (roluperidone): its Phase 2-b Eastern European trial vs. the “well-controlled” test of the FDA (Title 21, Section Sec. 314.126), whether Minerva previously justified the failure to use commercial formulation to conduct said study, as well as the feedback from the FDA during preliminary discussions regarding the potential NDA for MIN-101.

Main Event

Phase 3 Failure

05/29/2020

Company Statement

Minerva discloses the results of the Phase 3 study: “The primary objective of the trial was to evaluate the change from baseline to Week 12 of NSFS with 32 mg and 64 mg doses of roluperidone compared to placebo in patients diagnosed with schizophrenia presenting with moderate to severe negative symptoms. Neither the 32 mg nor 64 mg dose of roluperidone showed a statistically significant separation from placebo (32 mg: p ≤0.256, effect size [ES]=0.1; 64 mg: p ≤0.064, ES=0.2). Furthermore, neither dose showed a statistically significant separation from placebo on the key secondary endpoint, the change from baseline to Week 12 in PSP (32 mg: p ≤0.542, ES=0.1; 64 mg: nominal p ≤0.021, ES=0.3).”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$3.71 $13.47 $-9.76 -72.46%
See more on Factual Timeline

Initial Lawsuit

Plaintiff brings this securities class action on behalf of all investors who purchased or otherwise acquired Minerva Neurosciences, Inc. common stock between May 15, 2017 and November 30, 2020, inclusive.

  • Filing Date
    12/08/2020
  • Class Period
    05/15/2017 to 11/30/2020
  • Transgression
    Securities Violation
  • Filing Firms
    Block & Leviton, LLP
  • Case Title
    Mccoy v. Minerva Neurosciences, Inc.
  • Docket Number
    1:20-cv-12176
  • Court
    Massachusetts District Court
  • Free File
    Complaint

Allegations

According to the complaint, defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects. Specifically, defendants allegedly failed to disclose to investors 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.

Defendants

  • Company
    Minerva Neurosciences, Inc.
  • Chief Executive Officer
    Remy Luthringer

Lawsuit progression

  • Docket Number
    1:20-cv-12176
  • Court
    Massachusetts District Court

Lead Counsel

03/05/2021

The court issued an order appointing the lead plaintiff and lead counsel.

  • Lead Counsel
    Levi & Korsinsky, LLP
  • Lead Plaintiff
    Individual
  • Free File
    Order for lead

Dismissal

On 06/09/2021, plaintiff voluntarily dismissed the complaint.

The above-captioned consolidated action is hereby dismissed with prejudice as against all defendants on behalf of Lead Plaintiff pursuant to Federal Rule of Civil Procedure 41(a)(2) and without prejudice as against all defendants with respect to any other plaintiffs or unnamed putative class members.

Free File
Stipulation/Order of Dismissal

[stockdio-historical-chart symbol=”NERV” stockExchange=”NYSENasdaq” width=”500″ height=”330″ motif=”blinds” palette=”humanity” includeVolume=false]

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