UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 8.01 | Other Events. |
On December 12, 2022, Mirati Therapeutics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) completed its review of the Company’s new drug application (“NDA”) for KRAZATI™ (adagrasib), a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy, and approved the NDA. This indication is approved under accelerated approval based on objective response rate and duration of response. The full text of this press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release | |
| 104 | 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 hereunto duly authorized.
| Date: December 12, 2022 | MIRATI THERAPEUTICS, INC. | |||||
| By: | /s/ Reena R. Desai | |||||
| Reena R. Desai | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||