Bristol Myers - Merck's Thalassemia Candidate Under FDA Priority Review

The FDA has accepted for review Bristol Myers Squibb Co's BMY supplemental application seeking approval for Reblozyl (luspatercept-aamt) in adults with non-transfusion dependent (NTD) beta-thalassemia.

• The FDA has set a Prescription Drug User Fee Act goal date of March 27, 2022.
• In addition, the European Medicines Agency has validated the Type II variation for Reblozyl in NTD beta-thalassemia. 
• Reblozyl is being co-developed and co-commercialized with Merck & Co Inc MRK following Merck's recent acquisition of Acceleron Pharma Inc.
• These applications were based on safety and efficacy results from the pivotal Phase 2 BEYOND study evaluating Reblozyl plus best supportive care in patients with NTD beta-thalassemia.
• See here Benzinga's Full FDA Calendar.
• Price Action: BMY shares are up 1.77% at $56.39, while MRK stock is down 1.08% at $73.09 during the market session on the last check Friday.