Axovant Gene Therapies Receives Orphan Drug Designation from FDA for AXO-AAV-GM1 for the Treatment of GM1 Gangliosidosis
Axovant Gene Therapies Ltd. (AXGT)
Last axovant gene therapies ltd. earnings: 2/10 06:00 am
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Source: GlobeNewswire
NEW YORK and BASEL, Switzerland, Nov. 18, 2019 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the Company’s investigational gene therapy, AXO-AAV-GM1, for the treatment of GM1 gangliosidosis. GM1 gangliosidosis is a progressive and fatal pediatric lysosomal storage disorder caused by mutations in the GLB1 gene leading to impaired production of the beta-galactosidase enzyme. The Company is planning to complete enrollment of patients in Part A of the AXO-AAV-GM1 registrational program evaluating safety and efficacy and expects to announce 6-month data from Part A in mid-2020. “We are pleased to receive orphan drug designation for our GM1 gangliosidosis program as we advance the development of this potentially transformative, one-time gene therapy,” said Dr. Gavin Corcoran, chief R&D officer at Axovant
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