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Absence of Black Box Warning For Bristol Myers' Schizophrenia Treatment Could Enhance Alzheimer's Psychosis Potential
BOXBox(BOX) Benzinga·2024-09-27 19:06

Group 1 - The FDA approved Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) for treating schizophrenia in adults, which is a significant positive for the company's shares due to the absence of a boxed warning [1] - BMO Capital projects peak sales of 2.4billionforCobenfyinschizophreniaand2.4 billion for Cobenfy in schizophrenia and 3.9 billion in Alzheimer's related-psychosis, raising the price target to 53from53 from 48 [1] - Cobenfy will be priced at 1,850fora30daysupply,representingadiscounttopreviousexpectations[1]Group2TruistSecuritieshighlightsAbbVieIncsemraclidineasacompetingtreatmentforschizophreniaandAlzheimersdiseaserelatedpsychosis,butnotesthatCobenfyhasafirstmoveradvantage[2]WilliamBlairprojectspeakU.S.salesforCobenfytoreachapproximately1,850 for a 30-day supply, representing a discount to previous expectations [1] Group 2 - Truist Securities highlights AbbVie Inc's emraclidine as a competing treatment for schizophrenia and Alzheimer's disease-related psychosis, but notes that Cobenfy has a first-mover advantage [2] - William Blair projects peak U.S. sales for Cobenfy to reach approximately 2 billion by 2030, driven solely by its use in treating schizophrenia [2] - If Cobenfy is approved for additional indications, annual sales could rise to around 3billionto3 billion to 5 billion, pending positive results from ongoing Phase 3 trials [2] Group 3 - The label for Cobenfy includes caution for urinary retention, elevated heart rate, reduced gastric motility, and angioedema, despite lacking a black box warning [3] - BMY stock increased by 2.33% to $51.29 following the FDA approval [3]