UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 8, 2023 |
CRISPR THERAPEUTICS AG
(Exact name of Registrant as Specified in Its Charter)
Switzerland | 001-37923 | Not Applicable | ||
(State or Other Jurisdiction | (Commission File Number) | (IRS Employer | ||
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Baarerstrasse 14 |
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6300 Zug, Switzerland |
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(Address of Principal Executive Offices) |
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Registrant’s Telephone Number, Including Area Code: 41 (0)41 561 32 77 |
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(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
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| Trading |
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Common Shares, nominal value CHF 0.03 |
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| The Nasdaq Global Market |
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
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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 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. |
