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): September 24, 2018

 

Verastem, Inc.

(Exact Name of Registrant as Specified in Charter)

 

Delaware

 

001-35403

 

27-3269467

(State or Other Jurisdiction
of Incorporation)

 

(Commission
File Number)

 

(IRS Employer
Identification No.)

 

117 Kendrick Street, Suite 500, Needham, MA

 

02494

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (781) 292-4200

 

 

(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 (see General Instruction A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

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 o

 

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. o

 

 

 



 

Item 8.01 Other Events.

 

On September 24, 2018, Verastem, Inc. issued a press release announcing that the United States Food and Drug Administration (FDA) approved COPIKTRA™ (duvelisib) capsules for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma after at least two prior therapies and relapsed or refractory follicular lymphoma after at least two prior systemic therapies.

 

The follicular lymphoma indication has been granted by the FDA under accelerated approval based on overall response rate. Continued approval for that indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

EXHIBIT INDEX

 

Exhibit No.

 

Description

99.1

 

Press Release issued by Verastem, Inc. on September 24, 2018.

 

2



 

SIGNATURE

 

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.

 

 

Date: September 24, 2018

By:

/s/ Sean C. Flynn

 

 

Sean C. Flynn

 

 

Vice President, General Counsel and Secretary

 

3