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  • 8-K Filing

Minerva Neurosciences (NERV) 8-KCompany to Request Pre-NDA Meeting with U.S. Food and Drug Administration

Filed: 30 Sep 21, 8:53am
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    • 8-K Current report
    • 99.1 Company to Request Pre-NDA Meeting with U.S. Food and Drug Administration
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    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    Washington, D.C. 20549

     

     

    FORM 8-K

     

     

    CURRENT REPORT

    Pursuant to Section 13 or 15(d)

    of the Securities Exchange Act of 1934

    Date of Report (Date of earliest event reported): September 30, 2021

     

     

    Minerva Neurosciences, Inc.

    (Exact name of registrant as specified in its charter)

     

     

     

    Delaware 001-36517 26-0784194

    (State or other jurisdiction

    of incorporation)

     

    (Commission

    File Number)

     

    (I.R.S. Employer

    Identification No.)

     

    1601 Trapelo Road

    Suite 286

    Waltham, MA

     02451

    (Address of principal executive offices)

     

    (Zip Code)

    (Registrant’s telephone number, including area code): (617) 600-7373

    (Former name or former address, if changed since last report)

     

     

    Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

     

    ☐

    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

     

    ☐

    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

     

    ☐

    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

     

    ☐

    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class

     

    Trading

    Symbol(s)

     

    Name of each exchange

    on which registered

    Common Stock, $0.0001 par value per share NERV The Nasdaq Global Market

    Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

    Emerging growth company ☐

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

     

     

     


    Item 8.01

    Other Events.

    On September 30, 2021, Minerva Neurosciences, Inc. issued a press release announcing results from a pivotal bioequivalence study comparing the roluperidone formulations used in its late-stage Phase 2b and Phase 3 trials, and the planned commercial formulation. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

     

    Item 9.01

    Financial Statements and Exhibits

     

     (d)

    Exhibits

     

    Exhibit No.  

    Description

    99.1  Press release of Minerva Neurosciences, Inc. dated September 30, 2021
    104  Cover Page Interactive Data File (embedded within the Inline XBRL document).


    SIGNATURE

    Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     

    MINERVA NEUROSCIENCES, INC.
    By: 

    /s/ Geoffrey Race

    Name: Geoffrey Race
    Title: Executive Vice President, Chief Financial Officer and Chief Business Officer

    Date:    September 30, 2021

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