SEC Filings

8-K
AVEXIS, INC. filed this Form 8-K on 09/29/2017
Entire Document
 

 

Item 8.01.             Other Events.

 

On September 29, 2017, AveXis, Inc. (the “Registrant”) issued a press release to announce that the U.S. Food and Drug Administration has notified the Registrant that it may initiate its planned pivotal trial of AVXS-101 in spinal muscular atrophy (“SMA”) Type 1 using the intravenous formulation produced by the Registrant’s Good Manufacturing Practice commercial manufacturing process. A copy of this press release is furnished herewith as Exhibit 99.1 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

 

Press Release, dated September 29, 2017, titled “AveXis Announces Plan to Initiate Pivotal Trial of AVXS-101 in SMA Type 1 Using Product from New GMP Commercial Process.”

 

2



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