0000950170-23-070582.txt : 20231215 0000950170-23-070582.hdr.sgml : 20231215 20231215085816 ACCESSION NUMBER: 0000950170-23-070582 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20231215 ITEM INFORMATION: Other Events FILED AS OF DATE: 20231215 DATE AS OF CHANGE: 20231215 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CRISPR Therapeutics AG CENTRAL INDEX KEY: 0001674416 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 473173478 STATE OF INCORPORATION: V8 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37923 FILM NUMBER: 231488939 BUSINESS ADDRESS: STREET 1: BAARERSTRASSE 14 CITY: ZUG STATE: V8 ZIP: CH-6300 BUSINESS PHONE: 6173154600 MAIL ADDRESS: STREET 1: BAARERSTRASSE 14 CITY: ZUG STATE: V8 ZIP: CH-6300 8-K 1 crsp-20231215.htm 8-K 8-K
0001674416false00-000000000016744162023-12-152023-12-15

 

 

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): December 15, 2023

 

 

CRISPR THERAPEUTICS AG

(Exact name of Registrant as Specified in Its Charter)

 

 

Switzerland

001-37923

Not Applicable

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

Baarerstrasse 14

 

6300 Zug, Switzerland

 

Not Applicable

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 41 (0)41 561 32 77

 

 

(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 Shares, nominal value CHF 0.03

 

CRSP

 

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 December 15, 2023, it was announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for the conditional approval of CASGEVY™ (exagamglogene autotemcel), a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia being jointly developed by CRISPR Therapeutics AG and its partner, Vertex Pharmaceuticals Incorporated. The use of CASGEVY in the European Union remains investigational. An approval decision by the European Commission is expected in February 2024.

Conditional marketing authorizations ("CMAs") are for medicines that fulfil a significant unmet medical need such as being for serious and life-threatening diseases, where no satisfactory treatment methods are available or where the medicine offers a major therapeutic advantage. A CMA is granted where comprehensive clinical data is not yet complete, but the benefit of the medicine to address a significant unmet need outweighs the need for data that will become available in the future. CMAs are valid for one year and renewable annually with ongoing regulatory review of data.

 

 

SIGNATURES

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 thereunto duly authorized.

 

 

 

CRISPR Therapeutics AG

 

 

 

 

Date:

 December 15, 2023

By:

/s/ Samarth Kulkarni

 

 

 

Samarth Kulkarni, Ph.D.
Chief Executive Officer

 

 

 

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