Shares of aTyr Pharma (NASDAQ: LIFE) are up more than 15% after the company said its lead product candidate, Resolaris™, received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of limb girdle muscular dystrophy (LGMD) patients. Resolaris is derived from a naturally occurring protein released by human skeletal muscle cells and is being developed as an intravenous protein therapeutic for the treatment of rare myopathies with an immune component, such as LGMD. Being granted Orphan Drug Designation by the FDA will advance the development of Resolaris and create opportunity for incentives under the program. “Receiving Orphan Drug Designation for the treatment of all types of LGMD patients with Resolaris is an important step in our overall process of bringing our first Physiocrine-based product candidate to the market to treat patients,” aTyr Pharma 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 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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