SEC Filings

AVEXIS, INC. filed this Form 8-K on 11/09/2017
Entire Document

Exhibit 99.1



Media Inquiries:

Lauren Barbiero

W2O Group



Investor Inquiries:

Jim Goff

AveXis, Inc.



AveXis Reports Third Quarter 2017 Financial and Operating Results


— First patient has been dosed in pivotal trial of AVXS-101 for SMA Type 1 —


— Conference call and webcast November 9 at 4:30 p.m. EST —


Chicago, Ill. (November 9, 2017) — AveXis, Inc. (NASDAQ: AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today reported financial results for the third quarter ended September 30, 2017, recent corporate highlights and upcoming milestones.


“We had several significant accomplishments this quarter, and the recent dosing of our first patient in the pivotal study for SMA Type 1 using AVXS-101 product derived from our GMP process is a very exciting milestone for the company and the patients we serve,” said Sean Nolan, President and Chief Executive Officer of AveXis. “The anticipated initiation of the Type 2 trial, as well as our upcoming end-of-Phase 1 meeting later this quarter to further inform the regulatory pathway for AVXS-101, will propel us into an eventful 2018.”


Recent Highlights


Initiated Pivotal Trial of AVXS-101 in SMA Type 1 Using Product from New Good Manufacturing Practice (GMP) Commercial Process: On September 29, AveXis announced the U.S. Food and Drug Administration (FDA) notified the company it may initiate its planned pivotal trial of AVXS-101 for patients with spinal muscular atrophy (SMA) Type 1 using the intravenous (IV) formulation produced by the company’s GMP commercial manufacturing process.



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