Reversing from a pre-market spike, shares of aTyr Pharma (NASDAQ: LIFE) are down 4% on word that the company’s Resolaris™ has received Orphan Drug Designation from the European Medicines Agency (EMA) for the treatment of limb girdle muscular dystrophy (LGMD) patients. Orphan designation was advised following a positive opinion by the EMA’s Committee for Orphan Medicinal Products. Medicines that receive the designation are eligible for various incentives, including assistance with development of the medicine; reduced fees for marketing-authorization applications; and extended market exclusivity once the medicine is authorized. The company also received Orphan Drug Designation from the U.S. FDA earlier this week. “The Resolaris program has now been granted Orphan Drug Designation for both LGMD and facioscapulohumeral muscular dystrophy (FSHD) from the FDA and the EMA, as well as Fast Track designation for both rare myopathies with an immune component from the FDA. We are pleased with the development of Resolaris from a clinical and regulatory standpoint. We look forward to continuing to develop this potential therapy to help treat patients with these rare myopathies, for which there are limited or no treatment options, across the globe,” CEO John Mendlein stated in the news release.
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About aTyr Pharma
aTyr Pharma is engaged in the discovery and clinical development of innovative medicines for patients suffering from severe, rare diseases using its knowledge of Physiocrine biology, a newly discovered set of physiological pathways. The company’s lead candidate, Resolaris™, is a potential first-in-class intravenous protein therapeutic for the treatment of rare myopathies with an immune component. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 80 issued or allowed patents and over 230 pending patent applications that are owned or exclusively licensed by aTyr, including over 300 potential Physiocrine-based protein compositions. aTyr’s key programs are currently focused on severe, rare diseases characterized by immune dysregulation for which there are currently limited or no treatment options. For more information, please visit www.atyrpharma.com.
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