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 |