2018 Press Releases

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12/03/18Novartis announces FDA filing acceptance and Priority Review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1
The AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)1, filing is supported by data from the START trial which demonstrated a dramatic increase in survival and transformative improvement in achievement of developmental milestones compared to the natural history of SMA Type 12 SMA Type 1 is a progressive neuromuscular disease and the leading cause of genetic mortality in infants globally 3 ZOLGENSMA® represents the first in a proprietary platform to treat rare, monogenic d... 
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05/03/18AveXis Reports First Quarter 2018 Financial and Operating Results
-- Significant progress across operating functions including licensing, clinical trials and regulatory interactions -- -- AVXS-101 pre-BLA meeting with FDA is scheduled to be held in June 2018 -- CHICAGO, May 03, 2018 (GLOBE NEWSWIRE) --  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 first quarter ended March 31, 2018, rece... 
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05/01/18AveXis Provides Update on Proposed Acquisition by Novartis AG
CHICAGO, May 01, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced that the required waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 applicable to the proposed acquisition of AveXis by Novartis AG (Novartis) expired at 11:59 p.m. on April 30, 2018. On April 6, 2018, AveXis, Novartis and Novartis AM Mer... 
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04/25/18AveXis Announces First Patient Dosed in Phase 3 Trial of AVXS-101 in Pre-Symptomatic SMA Types 1, 2 and 3
CHICAGO, April 25, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced that the first patient has been dosed in a Phase 3 trial evaluating AVXS-101 in pre-symptomatic patients with spinal muscular atrophy (SMA) Types 1, 2 and 3 (SPRINT). “Treating SMA as early as possible is critically important in order to rescue motor neurons bef... 
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04/24/18AveXis Presents Initial Data from Pivotal U.S. Trial for SMA Type 1 and 24-Month Follow-Up Data from Phase 1 Trial of AVXS-101 in SMA Type 1 at the Annual Meeting of the American Academy of Neurology
– A mean increase in CHOP-INTEND of 17.3 was observed at three months post gene therapy in SMA Type 1 U.S. pivotal trial – – All patients in the therapeutic dose cohort in the Phase 1 trial were alive and event-free at 24-month follow-up – – Patients observed in long-term follow-up from the Phase 1 trial continued to gain strength and achieve new milestones, including two additional patients who could stand with assistance – CHICAGO, April 24, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ... 
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04/19/18AveXis to Present AVXS-101 Data at the Annual Meeting of the American Academy of Neurology
Includes Initial Data from SMA Type 1 Pivotal Trial (STR1VE) and 24-Month Follow-Up Data from Phase 1 Trial CHICAGO, April 19, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced that initial results from the pivotal study (STR1VE) of AveXis’ proprietary gene therapy, AVXS-101, for the treatment of spinal muscular atrophy (SMA) Type ... 
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04/09/18AveXis Enters Agreement to be Acquired by Novartis AG for $8.7 billion
Novartis to acquire AveXis for $218 per share in cash   AveXis’ lead product candidate, AVXS-101, expected to enhance Novartis’s position as a gene therapy and neuroscience leader   Transaction expected to be completed in mid-2018 CHICAGO, April 09, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) announced today that it has entered into an agreement and plan of merger with Novartis pursuant to which Novartis will acquire AveXis for $218 per share or a total of $8.7 billion in ca... 
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03/27/18AveXis Gene Therapy Awarded SAKIGAKE Designation for Spinal Muscular Atrophy Type 1
CHICAGO, March 27, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) awarded the company’s initial product candidate, AVXS-101, SAKIGAKE Designation (SAKIGAKE) for the treatment of spinal muscular atrophy (SMA) Type 1. The designation was based on data from the Phase 1 clini... 
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03/13/18AveXis Enters into Licensing Agreement with Genethon
Includes exclusive worldwide rights to AAV9-SMN product and route of administration CHICAGO and ÉVRY, France , March 13, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) and Genethon today announced they have entered into an exclusive, worldwide license agreement for in vivo gene therapy delivery of AAV9 vector into the central nervous system (CNS) for the treatment of spinal muscular atrophy (SMA). ... 
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02/27/18AveXis Reports Fourth Quarter and Full Year 2017 Financial and Operating Results
– On track to request pre-BLA meeting with FDA in Q2 2018 – – Intends to initiate pivotal trial in SMA Type 1 in Europe and multi-national pre-symptomatic SMA study in the first half of 2018 – – Anticipates IND submissions for Rett syndrome and genetic ALS in late 2018/early 2019 – – Conference call and webcast February 27 at 4:30 p.m. EST – CHICAGO, Feb. 27, 2018 (GLOBE NEWSWIRE) --   AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients... 
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02/20/18AveXis to Report Fourth Quarter and Full Year 2017 Financial and Operating Results
Conference call and webcast on February 27 at 4:30 p.m. EST CHICAGO, Feb. 20, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, will report financial and operating results for the fourth quarter and full year ended December 31, 2017, as well as recent corporate highlights, on Tuesday, February 27, 2018, after the close of U.S.-based financial mark... 
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01/30/18AveXis to Initiate Screening for Remaining Patients in Pivotal Trial of AVXS-101 for SMA Type 1 Following Review of Preliminary Data from First Three Patients
CHICAGO, Jan. 30, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today announced that, following review of safety data and early signals of efficacy from the first three patients dosed in its pivotal trial of AVXS-101 for spinal muscular atrophy (SMA) Type 1, the company, with agreement from the U.S. Food and Drug Administration, will initiate s... 
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01/22/18AveXis Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares
CHICAGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the closing of its previously announced underwritten public offering of 4,509,840 shares of its common stock at a price to the public of $102.00 per share before underwriting discounts and commissions, including 588,240 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares. The net proceeds to AveXis from the offering, after deducting the underwriting discounts ... 
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01/16/18AveXis Announces Pricing of Public Offering of Common Stock
CHICAGO, Jan. 16, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the pricing of an underwritten public offering of 3,921,600 shares of its common stock at a public offering price of $102.00 per share, before underwriting discounts and commissions. The net proceeds to AveXis from the offering, after deducting the underwriting discounts and commissions and estimated offering expenses payable by AveXis, are expected to be approximately $375.5 million. The offering is expected... 
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01/16/18AveXis Announces Proposed Public Offering of Common Stock
CHICAGO, Jan. 16, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced that it intends to offer and sell, subject to market conditions, up to $400 million of shares of its common stock in an underwritten public offering.  The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering. Goldman Sachs & Co. LLC, Jefferies LLC and BofA Merrill Lynch are acti... 
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01/16/18AveXis Announces Expanded Clinical Development Program for AVXS-101 in Spinal Muscular Atrophy
– Company to expand study of AVXS-101 into additional SMA populations including pre-symptomatic, older pediatric Type 2 and Type 3 SMA patients – – First patient dosed in Phase 1 trial of AVXS-101 in SMA Type 2 – CHICAGO, Jan. 16, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today provided an overview of the expanded clinical development p... 
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01/08/18REGENXBIO and AveXis Announce Expansion of Relationship through Amended License Agreement for the Development and Commercialization of Treatments for Spinal Muscular Atrophy
AveXis acquires exclusive rights to entire NAV Technology Platform for the development of treatments for SMA Amended agreement permits assignment by AveXis upon a change of control without REGENXBIO’s consent REGENXBIO could receive up to $260 million, including $140 million in guaranteed upfront and annual payments               ROCKVILLE, Md. and CHICAGO, Jan. 08, 2018 (GLOBE NEWSWIRE) -- REGENXBIO Inc. (Nasdaq:RGNX) and AveXis, Inc. (Nasdaq:AVXS) today announced that they have en... 
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01/04/18AveXis Announces Alignment with FDA on Next Steps Toward a BLA Submission for AVXS-101 in SMA Type 1
– Company to submit information requested by FDA to the IND on an on-going basis – – AveXis plans to request a pre-BLA meeting in Q2 2018 – – Conference call and webcast today at 4:30 pm EST – CHICAGO, Jan. 04, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases, today provided an update following the receipt of minutes from the end-of-Phase 1 m... 
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