false 0001598646 0001598646 2020-09-08 2020-09-08

 

 

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 8, 2020

 

 

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 2, 2020, the U.S. Food and Drug Administration (FDA) granted Minerva Neurosciences, Inc. (the “Company”) a Type C meeting, and scheduled it to take place via teleconference on November 10, 2020.

This meeting will provide an opportunity for the Company to review clinical data generated to date with roluperidone, including the recently completed Phase 3 trial of roluperidone for treatment of negative symptoms in schizophrenia, and to solicit comments and recommendations from the FDA regarding these data and the readiness of the roluperidone data package to support a new drug application submission.

It is possible that the FDA could cancel or reschedule this meeting, and the Company does not expect to receive the official minutes of the meeting until mid or late December, 2020.


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 8, 2020

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