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AskBio’s AB-1003 Receives Rare Pediatric Disease and Orphan Drug Designations from FDA
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Asklepios BioPharmaceutical, Inc. (AskBio), a wholly owned subsidiary of Bayer AG (ETR: BAYN), has announced that it has received both rare pediatric disease designation (RPDD) and orphan-drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational gene therapy, AB-1003 (LION-101). The therapy targets limb-girdle muscular dystrophy…
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Bayer’s Asklepios BioPharmaceutical Launches Phase II Trial for AAV Therapy in Heart Failure
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Bayer’s (ETR: BAYN) gene therapy subsidiary, Asklepios BioPharmaceutical, has initiated patient recruitment for a Phase II clinical trial of its adeno-associated virus (AAV) therapy AB-1002 targeting congestive heart failure (CHF). This placebo-controlled study aims to assess the safety and efficacy of intracoronary infusion in 90 to 150 adults with non-ischemic…
