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): June 19, 2019
 |
EXELIXIS, INC. (Exact name of registrant as specified in its charter) |
Delaware | 000-30235 | 04-3257395 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
1851 Harbor Bay Parkway
Alameda, California 94502
(Address of principal executive offices) (Zip Code)
(650) 837-7000
(Registrant’s telephone number, including area code)
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):
¨ 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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Common Stock $.001 Par Value per Share | EXEL | The Nasdaq Stock Market LLC |
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 ¨
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. ¨
Item 7.01. Regulation FD Disclosure.
On June 19, 2019, Exelixis, Inc. (“Exelixis”) was informed by its collaboration partner Genentech, a member of the Roche Group (“Genentech”), that IMspire170, the phase 3 trial evaluating the combination of cobimetinib, an Exelixis-discovered MEK inhibitor, and atezolizumab, an anti-PDL1 antibody discovered and developed by Genentech, did not meet its primary endpoint of progression-free survival compared to pembrolizumab, a current standard of care, in patients with previously untreated BRAF V600 wild-type advanced melanoma.
IMspire170 showed the combination of cobimetinib and atezolizumab did not reduce the risk of disease progression or death compared to pembrolizumab. The safety profile observed in the trial was consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Genentech, the sponsor of IMspire170, informed Exelixis that Genentech intends to present results from the trial at an upcoming medical meeting.
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.
EXELIXIS, INC. | ||||
June 20, 2019 | /s/ JEFFREY J. HESSEKIEL | |||
Date | Jeffrey J. Hessekiel | |||
Executive Vice President and General Counsel | ||||