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 8.01 Other Events.
On November 16, 2023, CRISPR Therapeutics AG (the "Company") and its partner, Vertex Pharmaceuticals, announced that CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy being jointly developed by the Company and Vertex Pharmaceuticals, received conditional marketing authorization from the United Kingdom Medicines and Healthcare products Regulatory Agency for the treatment of patients 12 years of age and older with sickle cell disease with recurrent vaso-occlusive crises or transfusion-dependent beta thalassemia, for whom a human leukocyte antigen matched related hematopoietic stem cell donor is not available.
Conditional marketing authorizations ("CMAs") are for medicines that fulfill 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 it is judged that such data will become available soon. 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: |
November 16, 2023 |
By: |
/s/ Samarth Kulkarni |
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Samarth Kulkarni, Ph.D. |