Acceleron Receives FDA Fast Track Designation for ACE-083 in Charcot-Marie-Tooth Disease
Acceleron Pharma Inc. (XLRN)
Last acceleron pharma inc. earnings: 2/27 04:05 pm
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Source: Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track designation to ACE-083, the Company’s locally-acting “Myostatin+” muscle agent, for the treatment of patients with Charcot-Marie-Tooth disease (CMT). “We’re pleased that the FDA has granted this designation for ACE-083,” said Robert K. Zeldin, M.D., Chief Medical Officer of Acceleron. “Patients with CMT currently have no approved therapies. To date, results from our Phase 2 trials have shown that patients treated with ACE-083 experience robust increases in muscle volume. If our ongoing clinical studies show that ACE-083 also improves functional outcomes and confirm the favorable safety profile observed thus far, th
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