SEC Filings

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 Description




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.”



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