SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 6, 2017
Axovant Sciences Ltd.
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of
(Commission File No.)
(I.R.S. Employer Identification No.)
Suite 1, 3rd Floor
11-12 St. James's Square London SW1Y 4LB, United Kingdom
(Address of principal executive office)
Registrant’s telephone number, including area code: +44 203 318 9708
(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))
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 x
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 8.01 Other Events.
Axovant has submitted a final protocol with statistical analysis plan to the U.S Food and Drug Administration that designates the Unified Parkinson Disease Rating Scale - Part III (UPDRS-III) as the primary efficacy endpoint, and the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog) and Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC+) as co-secondary endpoints for the Phase 2b HEADWAY study of its investigational drug intepirdine in patients with dementia with Lewy bodies. Previously, the primary efficacy evaluations were the Clinician’s Interview-Based Impression of Change plus Caregiver Input (CIBIC+) and a computerized cognitive battery.
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Axovant Sciences Ltd.
Date: December 6, 2017
/s/ Gregory Weinhoff
Principal Financial Officer