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): March 31, 2016
Xenon Pharmaceuticals Inc.
(Exact Name of Registrant as Specified in Charter)
Canada | 001-36687 | 98-0661854 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
200-3650 Gilmore Way Burnaby, British Columbia V5G 4W8 Canada |
(Address of principal executive offices including zip code) |
(604) 484-3300
(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)) |
Item 8.01. Other Events.
On March 31, 2016, Xenon Pharmaceuticals Inc. (the “Company”) issued a press release providing the development status of its and its collaborators’ product candidates, including an update to the anticipated timing of results from Teva Pharmaceutical Industries Ltd.’s (“Teva”) ongoing randomized, double-blind, placebo-controlled Phase 2b clinical trial for TV-45070 in patients with post-herpetic neuralgia. Previously, Teva had anticipated results from this trial in the second half of 2016. In February 2016, Teva updated the clinicaltrials.gov website to indicate that the anticipated completion of the ongoing Phase 2b clinical trial is now expected in the first half of 2017. The Company became aware of this update on March 29, 2016 and, after confirming the accuracy of the adjusted timeline with Teva, issued a press release, a copy of which is attached hereto as Exhibit 99.1 and which is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. | ||
Exhibit Number | Description | |
99.1 | Press release dated March 31, 2016. |
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.
Xenon Pharmaceuticals Inc. | ||
Date: March 31, 2016 | By: | /s/ Ian Mortimer |
Ian Mortimer | ||
Chief Financial Officer and Chief Operating Officer | ||
EXHIBIT INDEX
Exhibit Number | Description | |
99.1 | Press Release dated March 31, 2016 |
EXHIBIT 99.1
Xenon Pharmaceuticals to Provide Business and Milestone Update at Needham Healthcare Conference
BURNABY, British Columbia, March 31, 2016 (GLOBE NEWSWIRE) -- Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced that Dr. Simon Pimstone, Xenon's President and Chief Executive Officer, will present a business update, including progress toward milestones, at the Needham Healthcare Conference at 12:50 pm ET on Tuesday, April 12, 2016, in New York City.
Anticipated Milestones
An audio webcast of the presentation will be broadcast live on the investors section of Xenon's website at www.xenon-pharma.com and will be available for replay for 30 days following the presentation.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering and developing a pipeline of differentiated therapeutics for orphan indications that it intends to commercialize on its own and for larger market indications that the company intends to partner with global pharmaceutical companies. Xenon has built a core enabling discovery platform, referred to as Extreme Genetics®, for the discovery of validated drug targets by studying rare human diseases with extreme traits, including diseases caused by mutations in ion channels, known as channelopathies. Xenon's Extreme Genetics® platform has yielded the first approved gene therapy product in the European Union and a broad development pipeline and multiple pharmaceutical partnerships, including with Teva and Genentech. For more information, please visit www.xenon-pharma.com.
Safe Harbor Statement
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995 and Canadian securities laws. These forward-looking statements are not based on historical fact, and include statements regarding our ability to achieve milestones in both our proprietary and partnered development programs, the anticipated enrollment in our Phase 2 clinical trial of XEN801, the anticipated timing of IND submissions with regulatory agencies, the initiation of future clinical trials, the timing of and results from our and our collaborators’ ongoing clinical trials and pre-clinical development activities, the potential efficacy, future development plans and commercial potential of our and our collaborators’ product candidates and the progress and potential of ongoing development programs. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of any of our or our collaborators' product candidates; our Extreme Genetics® discovery platform or ongoing collaborations may not yield additional product candidates; any of our or our collaborators' product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; we may not achieve additional milestones pursuant to our collaboration agreements; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission and the securities commissions in British Columbia, Alberta and Ontario. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.
“Xenon,” the Xenon logo, and “Extreme Genetics” are registered trademarks or trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions.
Investor/Media Contact:
Jodi Regts
Senior Director, Corporate Affairs
Xenon Pharmaceuticals Inc.
Phone: 604.484.3353
Email: investors@xenon-pharma.com