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 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.
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CRISPR Therapeutics AG |
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Date: |
December 15, 2023 |
By: |
/s/ Samarth Kulkarni |
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Samarth Kulkarni, Ph.D. |