Press Releases & Media Statements

Date Title  
Toggle Summary AveXis presents updated STRONG data at WMS demonstrating a higher mean increase in Hammersmith Functional Motor Scale-Expanded (HFMSE) scores among older SMA Type 2 patients following one-time intrathecal administration of AVXS-101
Basel, October 5, 2019 – AveXis, a Novartis company, today announced new interim data from the Phase 1/2 STRONG study for intrathecal (IT) administration of AVXS-101, demonstrating older patients (≥ 2 years and < 5 years) with spinal muscular atrophy
AveXis presents updated STRONG data at WMS demonstrating a higher mean increase in Hammersmith Functional Motor Scale-Expanded (HFMSE) scores among older SMA Type 2 patients following one-time intrathecal administration of AVXS-101
Basel, October 5, 2019 – AveXis, a Novartis company, today announced new interim data from the Phase 1/2 STRONG study for intrathecal (IT) administration of AVXS-101, demonstrating older patients (≥ 2 years and < 5 years) with spinal muscular atrophy
Toggle Summary Novartis Statement on Form 483 posting by US Food and Drug Administration (FDA)
Today the FDA posted information provided by the company to the FDA in response to its Form 483 issued on August 2, 2019. Our submission, which can be read here at ( https://www.fda.gov/media/131007/download ), reiterated our firm commitment to data
Novartis Statement on Form 483 posting by US Food and Drug Administration (FDA)
Today the FDA posted information provided by the company to the FDA in response to its Form 483 issued on August 2, 2019. Our submission, which can be read here at ( https://www.fda.gov/media/131007/download ), reiterated our firm commitment to data
Toggle Summary AveXis presents new data at EPNS continuing to show significant therapeutic benefit of Zolgensma® in prolonging event-free survival now up to 5 years of age in patients with spinal muscular atrophy (SMA) Type 1
BASEL, Switzerland , Sept. 19, 2019 /PRNewswire/ -- New interim data from SPR1NT study supports critical importance of early intervention in pre-symptomatic SMA patients, leading to age‑appropriate major milestone gain Updated results from global STR1VE study demonstrate that Zolgensma ®
AveXis presents new data at EPNS continuing to show significant therapeutic benefit of Zolgensma® in prolonging event-free survival now up to 5 years of age in patients with spinal muscular atrophy (SMA) Type 1
BASEL, Switzerland , Sept. 19, 2019 /PRNewswire/ -- New interim data from SPR1NT study supports critical importance of early intervention in pre-symptomatic SMA patients, leading to age‑appropriate major milestone gain Updated results from global STR1VE study demonstrate that Zolgensma ®
Toggle Summary AveXis Statement on Changes to Senior Leadership Team
AveXis shares Page Bouchard, DVM named Senior Vice President of Research and Chief Scientific Officer, AveXis, effective August 5, 2019. Dr Bouchard is a 27 year industry veteran with experience in well over 100 Investigational New Drug programs and dozens of New Drug Application/Biologics License
AveXis Statement on Changes to Senior Leadership Team
AveXis shares Page Bouchard, DVM named Senior Vice President of Research and Chief Scientific Officer, AveXis, effective August 5, 2019. Dr Bouchard is a 27 year industry veteran with experience in well over 100 Investigational New Drug programs and dozens of New Drug Application/Biologics License
Toggle Summary Novartis stands behind Zolgensma® (onasemnogene abeparvovec- xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy
Basel, August 6, 2019 – Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi). First and foremost, we are fully confident in the safety, quality and efficacy of Zolgensma.
Novartis stands behind Zolgensma® (onasemnogene abeparvovec- xioi) for the treatment of children less than 2 years of age with spinal muscular atrophy
Basel, August 6, 2019 – Today the FDA released a statement addressing data integrity issues with the Biologics License Application (BLA) for Zolgensma® (onasemnogene abeparvovec-xioi). First and foremost, we are fully confident in the safety, quality and efficacy of Zolgensma.
Toggle Summary AveXis Statement on Access to Zolgensma® (onasemnogene abeparvovec-xioi)
The FDA's May 2019 approval of Zolgensma ® , a gene therapy for spinal muscular atrophy (SMA) in pediatric patients less than 2 years of age, marked an important milestone within the SMA community. Zolgensma offers a new treatment option for children with SMA and their families.
AveXis Statement on Access to Zolgensma® (onasemnogene abeparvovec-xioi)
The FDA's May 2019 approval of Zolgensma ® , a gene therapy for spinal muscular atrophy (SMA) in pediatric patients less than 2 years of age, marked an important milestone within the SMA community. Zolgensma offers a new treatment option for children with SMA and their families.
Toggle Summary AveXis Announces Innovative Zolgensma® Gene Therapy Access Programs for US Payers and Families
One-time treatment with Zolgensma (onasemnogene abeparvovec-xioi) is designed to replace lifetime of chronic therapy for all pediatric patients with SMA   Annualized cost of Zolgensma is USD 425,000 per year for 5 years: 50% less than multiple established value-based pricing benchmarks including
AveXis Announces Innovative Zolgensma® Gene Therapy Access Programs for US Payers and Families
One-time treatment with Zolgensma (onasemnogene abeparvovec-xioi) is designed to replace lifetime of chronic therapy for all pediatric patients with SMA   Annualized cost of Zolgensma is USD 425,000 per year for 5 years: 50% less than multiple established value-based pricing benchmarks including
Toggle Summary AveXis receives FDA approval for Zolgensma®, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2 [1],[2]   Zolgensma (onasemnogene abeparvovec-xioi) is approved for the treatment of pediatric patients less
AveXis receives FDA approval for Zolgensma®, the first and only gene therapy for pediatric patients with spinal muscular atrophy (SMA)
SMA is a rare genetic disease that leads to progressive muscle weakness, paralysis and, when left untreated in its most severe form, permanent ventilation or death for most patients by age 2 [1],[2]   Zolgensma (onasemnogene abeparvovec-xioi) is approved for the treatment of pediatric patients less
Toggle Summary New AveXis data at AAN showed long-term durability of Zolgensma® in patients with spinal muscular atrophy (SMA) Type 1
Interim long-term follow-up data showed all enrolled Cohort 2 patients maintained motor function and milestones achieved during the Phase 1 START trial   Mean age of follow-up since dosing with Zolgensma ( onasemnogene abeparvovec-xioi; AVXS-101) was nearly four years, with some patients nearing
New AveXis data at AAN showed long-term durability of Zolgensma® in patients with spinal muscular atrophy (SMA) Type 1
Interim long-term follow-up data showed all enrolled Cohort 2 patients maintained motor function and milestones achieved during the Phase 1 START trial   Mean age of follow-up since dosing with Zolgensma ( onasemnogene abeparvovec-xioi; AVXS-101) was nearly four years, with some patients nearing
Toggle Summary AveXis presented robust data at AAN demonstrating efficacy of Zolgensma® in broad spectrum of spinal muscular atrophy (SMA) patients
  - Interim data reported for the first time from STRONG in SMA Type 2 showed rapid motor function gains and milestone achievements with intrathecal Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101) - New interim data from STR1VE in SMA Type 1 continued to show prolonged event-free survival,
AveXis presented robust data at AAN demonstrating efficacy of Zolgensma® in broad spectrum of spinal muscular atrophy (SMA) patients
  - Interim data reported for the first time from STRONG in SMA Type 2 showed rapid motor function gains and milestone achievements with intrathecal Zolgensma (onasemnogene abeparvovec-xioi; AVXS-101) - New interim data from STR1VE in SMA Type 1 continued to show prolonged event-free survival,
Toggle Summary AveXis data reinforce effectiveness of Zolgensma® in treating spinal muscular atrophy (SMA) Type 1
  Ph 3 STR1VE data show prolonged event-free survival, early and rapid increases in CHOP-INTEND and significant milestone achievement in SMA Type 1, consistent with START trial   First-in-human biodistribution data show transduction in intended CNS targets and widespread SMN expression comparable
AveXis data reinforce effectiveness of Zolgensma® in treating spinal muscular atrophy (SMA) Type 1
  Ph 3 STR1VE data show prolonged event-free survival, early and rapid increases in CHOP-INTEND and significant milestone achievement in SMA Type 1, consistent with START trial   First-in-human biodistribution data show transduction in intended CNS targets and widespread SMN expression comparable
Toggle Summary AveXis expands world-leading gene therapy manufacturing capacity with purchase of advanced biologics therapy manufacturing campus in Longmont, Colorado
Facility to become the largest of four state-of-the-art sites involved in manufacturing of AveXis gene therapies for pipeline of rare genetic diseases including spinal muscular atrophy AveXis plans to offer positions to all approximately 150 employees previously employed at the site, and to
AveXis expands world-leading gene therapy manufacturing capacity with purchase of advanced biologics therapy manufacturing campus in Longmont, Colorado
Facility to become the largest of four state-of-the-art sites involved in manufacturing of AveXis gene therapies for pipeline of rare genetic diseases including spinal muscular atrophy AveXis plans to offer positions to all approximately 150 employees previously employed at the site, and to
Toggle Summary Novartis 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 1 2 SMA
Novartis 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 1 2 SMA
Toggle Summary AveXis 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.
AveXis 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.
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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.
AveXis 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.
Toggle Summary AveXis 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)
AveXis 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)
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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.
AveXis 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.
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis 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.
AveXis 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.
Toggle Summary REGENXBIO 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
REGENXBIO 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
Toggle Summary AveXis 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
AveXis 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
Toggle Summary AveXis Announces Plan to Initiate Phase 1 Trial in SMA Type 2 Utilizing Intrathecal Delivery of AVXS-101
– The FDA notified AveXis it may initiate the Phase 1 trial in SMA Type 2 based on a review of data provided by the company; trial to commence immediately –              – The trial will evaluate safety, dosing and proof of concept for efficacy –              – The trial will use product produced
AveXis Announces Plan to Initiate Phase 1 Trial in SMA Type 2 Utilizing Intrathecal Delivery of AVXS-101
– The FDA notified AveXis it may initiate the Phase 1 trial in SMA Type 2 based on a review of data provided by the company; trial to commence immediately –              – The trial will evaluate safety, dosing and proof of concept for efficacy –              – The trial will use product produced
Toggle Summary 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 , Nov. 09, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from
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 , Nov. 09, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from
Toggle Summary AveXis to Report Third Quarter 2017 Financial and Operating Results
Conference call and webcast on November 9 at 4:30 p.m. EST CHICAGO , Nov. 02, 2017 (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
AveXis to Report Third Quarter 2017 Financial and Operating Results
Conference call and webcast on November 9 at 4:30 p.m. EST CHICAGO , Nov. 02, 2017 (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
Toggle Summary AveXis Announces New England Journal of Medicine Publication of Phase 1 Data of AVXS-101 Gene Replacement Therapy in Spinal Muscular Atrophy Type 1
– Patients who received a single dose of AVXS-101 resulted in longer survival, superior achievement of motor milestones, and better motor function than in historical cohorts – – As of August 7, 2017 , all patients are alive, event-free and have reached at least 20 months of age – – As of August 7,
AveXis Announces New England Journal of Medicine Publication of Phase 1 Data of AVXS-101 Gene Replacement Therapy in Spinal Muscular Atrophy Type 1
– Patients who received a single dose of AVXS-101 resulted in longer survival, superior achievement of motor milestones, and better motor function than in historical cohorts – – As of August 7, 2017 , all patients are alive, event-free and have reached at least 20 months of age – – As of August 7,
Toggle Summary AveXis to Report Top-line Data from the Phase 1 Clinical Trial of AVXS-101 in SMA Type 1 at the International Annual Congress of the World Muscle Society
– All patients were alive and event-free at 20 months of age as of the August 7, 2017 data cut-off – – Patients in Cohort 2 continue to demonstrate improvements in motor milestones – SAINT MALO, France , Oct. 03, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy
AveXis to Report Top-line Data from the Phase 1 Clinical Trial of AVXS-101 in SMA Type 1 at the International Annual Congress of the World Muscle Society
– All patients were alive and event-free at 20 months of age as of the August 7, 2017 data cut-off – – Patients in Cohort 2 continue to demonstrate improvements in motor milestones – SAINT MALO, France , Oct. 03, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy
Toggle Summary AveXis Announces Plan to Initiate Pivotal Trial of AVXS-101 in SMA Type 1 Using Product from New GMP Commercial Process
               – FDA notified AveXis it may initiate pivotal trial based on a review of data provided by the company following CMC Type B meeting –                    – Product used in the pivotal trial will be from the AveXis GMP manufacturing process; pivotal trial to commence immediately – –
AveXis Announces Plan to Initiate Pivotal Trial of AVXS-101 in SMA Type 1 Using Product from New GMP Commercial Process
               – FDA notified AveXis it may initiate pivotal trial based on a review of data provided by the company following CMC Type B meeting –                    – Product used in the pivotal trial will be from the AveXis GMP manufacturing process; pivotal trial to commence immediately – –
Toggle Summary AveXis Reports Second Quarter 2017 Financial and Operating Results
– AveXis on track to submit potency assay data to FDA in August – – Conference call and webcast August 10 at 4:30 p.m. EDT – CHICAGO , Aug. 10, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and
AveXis Reports Second Quarter 2017 Financial and Operating Results
– AveXis on track to submit potency assay data to FDA in August – – Conference call and webcast August 10 at 4:30 p.m. EDT – CHICAGO , Aug. 10, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and
Toggle Summary AveXis to Report Second Quarter 2017 Financial and Operating Results
-- Conference call and webcast on August 10 at 4:30 p.m. EDT -- CHICAGO , Aug. 03, 2017 (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
AveXis to Report Second Quarter 2017 Financial and Operating Results
-- Conference call and webcast on August 10 at 4:30 p.m. EDT -- CHICAGO , Aug. 03, 2017 (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
Toggle Summary AveXis Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares
CHICAGO , June 26, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the closing of its previously announced underwritten public offering of 4,111,250 shares of its common stock at a price to the public of $70.00 per share before underwriting discounts and commissions, including
AveXis Announces Closing of Public Offering of Common Stock and Full Exercise of Underwriters’ Option to Purchase Additional Shares
CHICAGO , June 26, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the closing of its previously announced underwritten public offering of 4,111,250 shares of its common stock at a price to the public of $70.00 per share before underwriting discounts and commissions, including
Toggle Summary AveXis Announces Pricing of Public Offering of Common Stock
CHICAGO , June 20, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the pricing of an underwritten public offering of 3,575,000 shares of its common stock.  The net proceeds to AveXis from the offering, after deducting the underwriting discounts and commissions and estimated
AveXis Announces Pricing of Public Offering of Common Stock
CHICAGO , June 20, 2017 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS) today announced the pricing of an underwritten public offering of 3,575,000 shares of its common stock.  The net proceeds to AveXis from the offering, after deducting the underwriting discounts and commissions and estimated