Verastem Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01 Regulation FD Disclosure.
On May 8, 2025, Verastem, Inc. issued a press release announcing that the United States Food and Drug Administration (“FDA”) has approved AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with recurrent Kirsten rat sarcoma viral oncogene homolog mutated (“KRAS mt”) low-grade serous ovarian cancer (“LGSOC”) who received prior systemic therapy.
The KRAS mt recurrent LGSOC indication has been granted by the FDA under accelerated approval based on the tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference.
The information in this Item 7.01, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such filing.
Item 8.01 Other Events.
On May 8, 2025, Verastem, Inc. announced it received FDA approval of AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets) for the treatment of adult patients with recurrent KRAS mt LGSOC who received prior systemic therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Item 9.01 Financial Statements and Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release, dated May 8, 2025, regarding the FDA approval of AVMAPKI™ and FAKZYNJA™ combination for the treatment of KRAS mt LGSOC. | |
| 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.
| VERASTEM, INC. | ||
| Dated: May 8, 2025 | By: | /s/ Daniel W. Paterson |
| Daniel W. Paterson | ||
| President and Chief Executive Officer | ||