Bristol Myers Squibb (BMY) – Get the Bristol-Myers Squibb Company Report stocks fell on Monday, despite news of positive news on the US and European fronts for its psoriasis drug, deucravacitinib.
Bristol Myers shares fell 2.3% to $ 55.23 in the latest check after the United States Food and Drug Administration accepted the company’s New Drug Application (NDA) and the Agency European Medicines Agency has also validated the marketing authorization application for deucravacitinib for the treatment of adults with moderate disorders and severe plaque psoriasis.
“The FDA has set the deadline for the Prescription Drug User Fee Act at September 10, 2022. These final regulatory steps are in addition to the acceptance of the NDA by the Japanese 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 claims are based on positive results from … pivotal trials, which evaluated once daily deucravacitinib in patients with moderate to severe plaque psoriasis compared to placebo and Otezla (apremilast),” a declared an Amgen. (AMGN) – Get the report from Amgen Inc. blockbuster, said Bristol Myers.
“Deucravacitinib demonstrated significant and clinically significant improvements in skin clearance, symptom burden and quality of life measures compared to placebo and Otezla.
“Deucravacitinib was well tolerated with a low discontinuation rate due to adverse events, without clinically significant laboratory abnormalities.”
Morningstar analyst Damien Conover estimates the fair value at $ 68. “Bristol Myers hosted an Investor Day highlighting a strong pipeline that has the potential to offset the company’s major patent losses over the next decade,” he wrote on November 16.