UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Emerging growth company
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Item 7.01 Regulation FD Disclosure.
On September 27, 2022, CRISPR Therapeutics AG (the “Company”) and its partner Vertex Pharmaceuticals Incorporated (together with its affiliates, “Vertex”) issued a press release announcing certain matters related to plans for global regulatory submissions for exagamglogene autotemcel (“exa-cel”). A copy of the press release is attached hereto as Exhibit 99.1.
The information in this Item 7.01 of Form 8-K, including the accompanying Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On September 27, 2022, the Company and Vertex announced that discussions with the U.S. Food and Drug Administration (“FDA”) have concluded, and the FDA granted exa-cel a rolling review for the potential treatment of sickle cell disease and transfusion-dependent beta thalassemia. The exa-cel biologics licensing application will be submitted for rolling review, beginning in November 2022 and the parties expect the submission to be complete by the end of the first quarter of 2023. Discussions were previously completed with the European Medicines Agency and the Medicines and Healthcare products Regulatory Agency on the data required to support marketing applications for exa-cel and such applications are on track for submission by the end of 2022.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
Exhibit |
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
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CRISPR Therapeutics AG |
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Date: |
September 27, 2022 |
By: |
/s/ Samarth Kulkarni |
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Samarth Kulkarni, Ph.D. |