百时美施贵宝精神分裂症治疗缺乏黑匣子警告可能会增强阿尔茨海默氏症的精神病潜力-动脉网

Absence of Black Box Warning For Bristol Myers' Schizophrenia Treatment Could Enhance Alzheimer's Psychosis Potential

benzinga 等信源发布 2024-09-27 15:06



可切换为仅中文







On Thursday, the FDA approved Bristol Myers Squibb & Co’s BMY Cobenfy (xanomeline and trospium chloride, KarXT), an oral medication for schizophrenia in adults.

周四，FDA批准了百时美施贵宝公司的BMY Cobenfy（xanomeline and trospium chloride，KarXT），一种治疗成人精神分裂症的口服药物。

BMO Capital analyst notes that the FDA approval without a boxed warning is a significant positive for Bristol Myers shares.

BMO Capital分析师指出，美国食品药品监督管理局（FDA）在没有盒装警告的情况下批准了该法案，这对百时美的股价是一个重大利好消息。

The analyst notes that given that many prior antipsychotic medications received black box warnings due to increased mortality risks, particularly in elderly patients, Cobenfy’s absence of such a warning could significantly enhance its potential in treating Alzheimer’s related-psychosis, pending further clinical trials..

这位分析人士指出，鉴于许多先前的抗精神病药物由于死亡风险增加而收到黑盒警告，特别是在老年患者中，科本菲没有这样的警告可能会显着提高其治疗阿尔茨海默病相关精神病的潜力，等待进一步的临床试验。。

BMO projects peak sales of $2.4 billion for Cobenfy in schizophrenia and $3.9 billion in Alzheimer’s related-psychosis, raising the price target to $53 from $48, with a Market Perform rating.

BMO预计，精神分裂症患者Cobenfy和阿尔茨海默病相关精神病患者的销售额峰值分别为24亿美元和39亿美元，将目标价格从48美元提高到53美元，市场表现评级。

The analyst notes that Cobenfy will be priced at $1,850 for a 30-day supply or $22,500/year, representing a discount to previous expectations.

该分析师指出，Cobenfy的30天供应价格将为1850美元，或每年22500美元，这比之前的预期有所折扣。

Truist Securities highlights that AbbVie Inc ABBV is also advancing emraclidine as a treatment for schizophrenia and Alzheimer’s disease-related psychosis.

Truist Securities强调，AbbVie Inc ABBV也正在推进依美拉西定治疗精神分裂症和阿尔茨海默病相关精神病。

According to Truist analysts, emraclidine differs from KarXT in its mechanism of action.

据Truist分析师称，emraclidine与KarXT的作用机制不同。

Despite emerging competition, Truist points out that KarXT holds a first-mover advantage and is ahead by at least two to three years.

。

Truist maintains the Buy rating and a price target of $62.

Truist维持买入评级，目标价格为62美元。

William Blair projects peak U.S. sales for Cobenfy to reach approximately $2 billion by 2030, driven solely by its use in treating schizophrenia.

威廉·布莱尔（WilliamBlair）预计，到2030年，Cobenfy在美国的销售额将达到约20亿美元，这完全是由于其用于治疗精神分裂症。

However, if the drug is approved for additional indications, such as Alzheimer-related psychosis and adjunctive schizophrenia—both currently in Phase 3 trials—annual sales could rise to around $3 billion to $5 billion, pending positive results.

然而，如果该药物被批准用于其他适应症，例如阿尔茨海默病相关精神病和辅助性精神分裂症，目前正在进行3期临床试验，在取得积极结果之前，年销售额可能会上升到30亿至50亿美元左右。

The analyst points out that although the label lacks a black box warning, it does include caution for urinary retention, elevated heart rate, reduced gastric motility, and angioedema.

分析员指出，虽然标签上没有黑匣子警告，但它确实包括了对尿潴留、心率升高、胃动力降低和血管性水肿的警告。

Price Action: BMY stock is up 2.33% at $51.29 at the last check on Friday.

价格走势：BMY股价在周五的最后一次检查中上涨2.33%，至51.29美元。