Shares of aTyr Pharma (NASDAQ: LIFE) climbed more than 25% in mid-day trade following news that the company’s Resolaris™ candidate was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy 2B, making it the first known therapeutic candidate to receive the designation for this treatment. The FDA also removed its partial clinical hold on a dosing ceiling for Resolaris in clinical trials, providing dosing flexibility moving forward. “This Fast Track designation, which is granted to drug candidates addressing serious conditions and that demonstrate the potential to address unmet medical needs, represents another step forward for our first product candidate based on the Physiocrine pathway,” CEO John Mendlein, PhD, 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 modulators. 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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