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 December 8, 2023, CRISPR Therapeutics AG (the “Company”) and its partner, Vertex Pharmaceuticals Incorporated (“Vertex”), announced receipt of the first-ever approval of a CRISPR-based gene-editing therapy in the United States. On December 8, 2023, the U.S. Food and Drug Administration (“FDA”) approved CASGEVY™ (exagamglogene autotemcel). CASGEVY is an autologous genome edited hematopoietic stem cell-based gene therapy indicated for the treatment of sickle cell disease in patients 12 years and older with recurrent vaso-occlusive crises.
Vertex has established a wholesale acquisition cost for CASGEVY in the United States of $2.2 million.
In addition, under the Amended and Restated Joint Development Agreement dated as of April 16, 2021 between the Company (and certain of its affiliates) and Vertex (and certain of its affiliates), the FDA’s approval of CASGEVY (as described above) triggered Vertex’s obligation to make a $200.0 million milestone payment to the Company.
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 8, 2023 |
By: |
/s/ Samarth Kulkarni |
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Samarth Kulkarni, Ph.D. |