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 14, 2016

 

Array BioPharma Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction

of incorporation) 

 
001-16633   84-1460811

(Commission

File Number) 

 

(I.R.S. Employer

Identification No.) 

 

3200 Walnut Street, Boulder, Colorado 80301
(Address of principal executive offices) (Zip Code)

 

303-381-6600

(Registrant’s telephone number, including area code)

 

  

(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))

 

 

 

 

In this report, “Array BioPharma,” “Array,” “we,” “us” and “our” refer to Array BioPharma Inc., unless the context otherwise provides.

 

Item 8.01 Other Information

 

On September 14, 2016, Array BioPharma announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) related to BEACON CRC, a global Phase 3 trial of encorafenib and Erbitux® (cetuximab), with or without binimetinib, versus standard of care in patients with BRAF-mutant colorectal cancer (CRC) who have previously received first-or second-line systemic therapy.
 

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

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

 Exhibit No.   Description
     
99.1   Press release dated September 14, 2016 announcing Special Protocol Assessment Agreement for BEACON CRC

 

 

 

 

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.

 

Date: September 14, 2016 Array BioPharma Inc.
     
     
  By:   /s/ Jason Haddock
    Jason Haddock
    Chief Financial Officer

  

 

 

 

EXHIBIT INDEX

 

Exhibit No.   Description
99.1   Press release dated September 14, 2016 announcing Special Protocol Assessment Agreement for BEACON CRC