Bristol Myers' Deucravacitinib Under FDA Review For Plaque Psoriasis

The FDA has accepted for review Bristol Myers Squibb & Co's BMY deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.

• The European Medicines Agency has also validated the deucravacitinib marketing application for plaque psoriasis.
• The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of September 10, 2022. 
• The regulatory applications are based on positive results from the pivotal POETYK PSO-1 and POETYK PSO-2 trials, which evaluated once-daily deucravacitinib versus placebo and Amgen Inc's AMGN Otezla (apremilast). 
• Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden, and quality of life measures compared to placebo and Otezla. 
• Deucravacitinib is an oral, selective tyrosine kinase 2 (TYK2) inhibitor.
• See here Benzinga's Full FDA Calendar.
• Price Action: BMY shares are down 1.02% at $55.96 during the market session on the last check Monday.