Bristol Myers Squibb (BMY) - Get Bristol-Myers Squibb Company Report shares fell on Monday, despite the announcement of positive news on both the U.S. and European fronts for its psoriasis drug deucravacitinib.
Shares of Bristol Myers were down 2.3% at $55.23 at last check after the U.S. Food and Drug Administration accepted the company's New Drug Application (NDA) and the European Medicines Agency also validated the Marketing Authorization Application for deucravacitinib for the treatment of adults with moderate to severe plaque psoriasis.
“The FDA has assigned a Prescription Drug User Fee Act goal date of Sept. 10, 2022. These latest regulatory milestones are in addition to the NDA acceptance by Japan's Ministry of Health, Labor and Welfare,” Bristol Myers said in a statement.
Deucravacitinib treats adults with moderate to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis.
“The regulatory applications are based on positive results from … pivotal … trials, which evaluated once daily deucravacitinib in patients with moderate to severe plaque psoriasis versus placebo and Otezla (apremilast),” an Amgen (AMGN) - Get Amgen Inc. Report blockbuster, Bristol Myers said.
“Deucravacitinib demonstrated significant and clinically meaningful improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla.
“Deucravacitinib was well-tolerated with a low rate of discontinuation due to adverse events, with no clinically meaningful lab abnormalities.”
Morningstar analyst Damien Conover puts fair value at $68. “Bristol Myers hosted an investor day highlighting a strong pipeline that holds the potential to offset the firm’s major patent losses over the next decade,” he wrote Nov. 16.