SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 06/19/2017
Entire Document
 

 

Risks related to the commercialization of AVXS-101’’ in our Annual Report on Form 10-K for the year ended December 31, 2016, which is incorporated by reference into this prospectus supplement. These risks include the risks of:

 

·                  completing preclinical studies and clinical trials with positive results;

·                  receiving marketing approvals from applicable regulatory authorities;

·                  obtaining, maintaining, defending and enforcing intellectual property rights important to the product candidates;

·                  establishing commercial manufacturing capabilities, or contracting with third-party manufacturers with such capabilities;

·                  establishing and maintaining collaborations, licensing or other arrangements;

·                  launching commercial sales, if and when approved;

·                  achieving acceptance, if and when approved, by patients and the medical community;

·                  effectively competing with other therapies; and

·                  maintaining an acceptable safety profile following approval.

 

If we are unable to successfully develop and commercialize product candidates for Rett syndrome or ALS, we will not be able to obtain future revenues from these programs, which would have a material adverse effect on our future business prospects, financial condition and results of operations.

 

Item 9.01.             Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Press Release, dated June 19, 2017, titled “AveXis Announces Proposed Public Offering of Common Stock.”

 

5



© AveXis, Inc. All Rights Reserved.