Acceleron Pharma

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Press Releases

Date Title and Summary
Toggle Summary Acceleron Reports First Quarter 2020 Operating and Financial Results
- REBLOZYL ® (luspatercept-aamt), a first-in-class erythroid maturation agent, was approved by the U.S. FDA to treat anemia in adults with lower-risk myelodysplastic syndromes (MDS) - - REBLOZYL received positive CHMP opinion for the treatment of adults with transfusion-dependent anemia in
Toggle Summary Acceleron to Webcast First Quarter 2020 Operating and Financial Results on May 11, 2020
CAMBRIDGE, Mass. --(BUSINESS WIRE)--May 5, 2020-- Acceleron Pharma Inc. (Nasdaq:XLRN) today announced it will host a webcast and conference call on Monday, May 11, 2020 at 5:00 p.m. EDT to discuss its first quarter 2020 operating and financial results.
Toggle Summary Acceleron Receives Priority Medicines (PRIME) Designation from European Medicines Agency (EMA) for Sotatercept in Pulmonary Arterial Hypertension
First therapeutic to receive PRIME designation in pulmonary arterial hypertension since the EMA established the program in 2016 PRIME designation comes just three weeks after US FDA granted sotatercept Breakthrough Therapy designation CAMBRIDGE, Mass.
Toggle Summary Reblozyl (luspatercept) Receives Positive CHMP Opinion for the Treatment of Adults with Anemia in Beta Thalassemia and Myelodysplastic Syndromes
Recommendation for approval based on results from pivotal Phase 3 MEDALIST and BELIEVE studies PRINCETON, N.J. & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 30, 2020-- Bristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that the Committee for Medicinal Products
Toggle Summary Acceleron Receives FDA Breakthrough Therapy Designation for Sotatercept in Pulmonary Arterial Hypertension
Sotatercept granted first FDA Breakthrough Therapy designation in pulmonary arterial hypertension since the Agency established the designation in 2012 CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 8, 2020-- Acceleron Pharma Inc. (Nasdaq: XLRN), a biopharmaceutical company dedicated to the discovery,
Toggle Summary Acceleron Announces Retirement of Director Jean George
CAMBRIDGE, Mass. --(BUSINESS WIRE)--Apr. 7, 2020-- Acceleron Pharma Inc. (Nasdaq:XLRN), a biopharmaceutical company dedicated to the discovery, development, and commercialization of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that Jean George is retiring
Toggle Summary U.S. Food and Drug Administration (FDA) Approves Reblozyl® (luspatercept-aamt), the First and Only Erythroid Maturation Agent, to Treat Anemia in Adults with Lower-Risk Myelodysplastic Syndromes (MDS)
The FDA approval marks the second indication for Reblozyl and the first new treatment option in over a decade for patients with MDS who require red blood cell (RBC) transfusions and have failed an erythropoiesis stimulating agent Reblozyl regulates late-stage RBC maturation to relieve patients from
Toggle Summary New England Journal of Medicine Publishes Results from Pivotal Phase 3 BELIEVE Trial of Reblozyl (luspatercept-aamt) in Adult Patients With Beta Thalassemia
Results demonstrate that treatment with Reblozyl provides significant reduction in transfusion burden for patients with beta thalassemia-associated anemia compared to placebo PRINCETON, N.J. & CAMBRIDGE, Mass. --(BUSINESS WIRE)--Mar. 26, 2020-- Bristol-Myers Squibb Company (NYSE:BMY) and Acceleron
Toggle Summary Acceleron Announces Topline Results from the Phase 2 Trial of ACE-083 in Patients with Charcot-Marie-Tooth Disease
– ACE-083 did not achieve statistically significant improvements in functional endpoints relative to placebo – – Acceleron to discontinue development of ACE-083 – CAMBRIDGE, Mass. --(BUSINESS WIRE)-- Acceleron Pharma Inc. (NASDAQ:XLRN), a biopharmaceutical company dedicated to the discovery,
Toggle Summary Acceleron Reports Fourth Quarter and Full Year 2019 Operating and Financial Results
- REBLOZYL ® (luspatercept-aamt), a first-in-class erythroid maturation agent, was approved by the U.S. FDA for the treatment of anemia in adult patients with beta-thalassemia who require regular red blood cell transfusions; FDA review of the sBLA for the lower-risk myelodysplastic syndromes