UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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.
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Item 7.01 Regulation FD Disclosure.
On April 3, 2023, CRISPR Therapeutics AG (the “Company”) and its partner, Vertex Pharmaceuticals Incorporated (“Vertex”), issued a press release announcing the completion of the rolling Biologics License Applications (“BLAs”) to the U.S. Food and Drug Administration (“FDA”) for the investigational treatment exagamglogene autotemcel (“exa-cel”) for sickle cell disease and transfusion-dependent beta thalassemia. 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 Information.
On April 3, 2023, the Company and Vertex announced the completion and submission of the rolling BLAs to the FDA for the product candidate, exa-cel, being investigated for the treatment of severe sickle cell disease and transfusion-dependent beta thalassemia in patients ages 12 to 35.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits:
The following exhibits shall be deemed to be furnished, and not filed:
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Description |
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99.1 |
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Press Release by CRISPR Therapeutics AG and Vertex Pharmaceuticals Incorporated, dated April 3, 2023 |
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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: |
April 3, 2023 |
By: |
/s/ Samarth Kulkarni |
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Samarth Kulkarni, Ph.D. |