0001193125-24-095472.txt : 20240415 0001193125-24-095472.hdr.sgml : 20240415 20240415064602 ACCESSION NUMBER: 0001193125-24-095472 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 13 CONFORMED PERIOD OF REPORT: 20240415 ITEM INFORMATION: Other Events FILED AS OF DATE: 20240415 DATE AS OF CHANGE: 20240415 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Neumora Therapeutics, Inc. CENTRAL INDEX KEY: 0001885522 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] ORGANIZATION NAME: 03 Life Sciences IRS NUMBER: 844367680 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-41802 FILM NUMBER: 24843071 BUSINESS ADDRESS: STREET 1: 490 ARSENAL WAY, SUITE 200 CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: (857) 760-0900 MAIL ADDRESS: STREET 1: 490 ARSENAL WAY, SUITE 200 CITY: WATERTOWN STATE: MA ZIP: 02472 FORMER COMPANY: FORMER CONFORMED NAME: RBNC Therapeutics, Inc. DATE OF NAME CHANGE: 20210929 8-K 1 d805556d8k.htm 8-K 8-K
false 0001885522 0001885522 2024-04-15 2024-04-15

 

 

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): April 15, 2024

 

 

NEUMORA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41802   84-4367680

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification Number)

490 Arsenal Way, Suite 200

Watertown, Massachusetts 02472

(Address of principal executive offices) (Zip Code)

(857) 760-0900

(Registrant’s telephone number, including area code)

N/A

(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   NMRA   The Nasdaq Global Select 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 April 15, 2024, Neumora Therapeutics, Inc. (the “Company”) announced that its Phase 1 trial of NMRA-266 has been placed on clinical hold by the U.S. Food and Drug Administration (“FDA”). NMRA-266 is a positive allosteric modulator (PAM) of the M4 muscarinic receptor and is part of the Company’s M4 PAM franchise. The clinical hold determination follows recently available pre-clinical data showing convulsions in rabbits. Following this action, the Phase 1 single ascending dose / multiple ascending dose study with NMRA-266 has been paused. Approximately 30 participants have been dosed in the Phase 1 study, with no evidence of convulsions observed in any participant. The Company is working with the FDA to evaluate the potential to resolve the clinical hold. While these discussions with the FDA are ongoing, the Company’s prior guidance regarding NMRA-266 is no longer applicable. The Company will provide an update on NMRA-266 when available.

SIGNATURES

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

 

    NEUMORA THERAPEUTICS, INC.
Date: April 15, 2024     By:  

/s/ Joshua Pinto

      Joshua Pinto
      Chief Financial Officer
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