SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 12/13/2017
Entire Document
 

 

Item 7.01                                           Regulation FD Disclosure.

 

On December 13, 2017, AveXis, Inc. (the “Registrant”) will host a live webcast to announce that the U.S. Food and Drug Administration (the “FDA”) has notified the Registrant that it may initiate its planned Phase 1 trial of AVXS-101 in spinal muscular atrophy (“SMA”) Type 2 using the intrathecal formulation produced by the Registrant’s Good Manufacturing Practice commercial manufacturing process. A copy of the slides to be presented during the webcast is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 8.01.             Other Events.

 

On December 13, 2017, the Registrant issued a press release regarding the initiation of its planned Phase 1 trial of AVXS-101 in SMA Type 2 using the intrathecal formulation produced by the Registrant’s Good Manufacturing Practice commercial manufacturing process. A copy of this press release is furnished herewith as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.

 

Item 9.01.             Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

 

 

Number

 

Exhibit Description

99.1

 

Slide Presentation, dated December 13, 2017, titled “Phase 1 SMA Type 2 Trial Initiation and Study Design.”

99.2

 

Press Release, dated December 13, 2017, titled “AveXis Announces Plan to Initiate Phase 1 Trial in SMA Type 2 Utilizing Intrathecal Delivery of AVXS-101.”

 

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