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Celgene ( CELG ) and its partner Acceleron Pharma ( XLRN ) announced that they had submitted their BLA for their biologic luspatercept to the FDA for potential regulatory approval. The BLA to the FDA will be for two different diseases associated with anemia. In addition, a regulatory submiss...
Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, announced that Robert K. Zeldin, M.D., Chief Medical Officer, is no longer employed by the company, as of today. ...
Celgene ( CELG +0.3% ) has filed a marketing application with the FDA seeking approval for luspatercept for the treatment of adult patients with very-low-to-intermediate-risk myelodysplastic syndromes-associated anemia who have ring sideroblasts and require red blood cell transfusions an...
BLA submission includes both myelodysplastic syndromes and beta-thalassemia indications EMA marketing application for both indications planned for Q2:19 Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that Celgene has submitted a Biol...
Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced it is discontinuing development of ACE-2494, a systemic muscle agent the company had been studyin...
The following slide deck was published by Acceleron Pharma Inc. in conjunction with this Read more ...
The FDA designates Acceleron Pharma's (NASDAQ: XLRN ) Fast Track-tagged ACE-083 an Orphan Drug for the treatment of Charcot-Marie-Tooth disease , an inherited neurological disorder characterized by the progressive loss of muscle tissue and touch sensation due to peripheral nerve damage. ...
Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to ...
Acceleron Pharma Inc. (XLRN) Q4 2018 Earnings Conference Call February 27, 2019 5:00 PM ET Company Participants Todd James - VP, IR & Corporate Communications Habib Dable - CEO, President & Director Robert Zeldin - Chief Medical Officer Kevin McLaughlin - CFO, Senior V...
The following slide deck was published by Acceleron Pharma Inc. in conjunction with their 2018 Q4 earnings Read more ...
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Believes Transaction Comes at the Wrong Time, With the Wrong Price, and Following the Wrong Process Remains Confident in Company’s Standalone Opportunities – Given Strong Momentum and Near-Term Inflection Point Coming from Phase 3 Data Stands Ready to Hel...
In September, Merck (NYSE: MRK) announced plans to acquire Acceleron Pharma (NASDAQ: XLRN) for $11.5 billion. However, the big drugmaker recently revealed that it withdrew a key regulatory filing document related to the transaction. In this Motley Fool Live video ...