On Monday, BMO Capital Markets maintained a Market Perform rating on shares of Bristol-Myers Squibb Co. (NYSE:BMY) with a steady price target of $48.00. The focus of investors is on the upcoming decision by the Food and Drug Administration (FDA) regarding KarXT, a treatment developed by Bristol-Myers. The Prescription Drug User Fee Act (PDUFA) date is set for September 26, and market participants are closely watching for the outcome.
The key point of interest is whether the FDA will require a black box warning (BBW) for KarXT, which is standard for antipsychotics due to the increased risk of death in elderly patients. The absence of such a warning could be beneficial for the drug's market reception. Analysts believe that if KarXT can avoid the BBW and demonstrate a lack of metabolic side effects, it could stand out in its class, particularly for its mechanism of action (MOA) through M1/M4 receptors.
Market analysts have noted that the approval of KarXT is likely already factored into the current share price of Bristol-Myers. However, there is potential for a 2-3% upside if the drug receives a favorable label without the BBW. This would be significant not only for the treatment of schizophrenia (SZ) but also for Alzheimer's psychosis, where KarXT could offer additional benefits.
The anticipation of the FDA's decision is high, as it could influence Bristol-Myers' position in the antipsychotic drug market. The effectiveness of KarXT's launch and its differentiation from other treatments due to its MOA could play a crucial role in the company's future growth. The market is now looking towards the end of September for clarity on the FDA's stance and the potential impact on Bristol-Myers' stock.
In other recent news, Bristol Myers Squibb reported significant strides in multiple sclerosis (MS) treatment with sustained reductions in brain volume loss in patients treated with Zeposia, according to new data from the Phase 3 DAYBREAK trial.
Concurrently, Goldman Sachs and Jefferies maintained their Buy and Hold ratings on the company, respectively, following encouraging updates on its oncology portfolio and a positive outlook on the company's factor XIa inhibitor, milvexian. Zenas BioPharma, backed by Bristol Myers Squibb among other investors, has initiated the process for a U.S. initial public offering.
The U.S. Food and Drug Administration is reviewing Bristol Myers Squibb's Opdivo in combination with Yervoy for the treatment of unresectable hepatocellular carcinoma, while the company is also seeking approval from the European Medicines Agency to extend the use of Breyanzi for certain follicular lymphoma patients.
Lastly, the company's blood thinner Eliquis has been selected by the Biden administration for price negotiations with the Medicare health program. These are recent developments in Bristol Myers Squibb's ongoing activities in the pharmaceutical industry.
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