PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY) reported new data from the Phase 3 DAYBREAK trial, indicating sustained reductions in brain volume loss in patients with relapsing forms of multiple sclerosis (MS) treated with Zeposia (ozanimod) for up to five years. The study found low and stable rates of whole brain volume (WBV) loss over the period.
In addition to the efficacy results, a separate safety analysis from the DAYBREAK open-label extension (OLE) revealed declining or stable rates of treatment-emergent adverse events (TEAEs) over more than eight years of Zeposia treatment. This data, along with 12 other abstracts, will be presented at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark.
The DAYBREAK OLE trial included 2,257 patients from the SUNBEAM and RADIANCE Phase 3 studies. It assessed the impact of Zeposia on rates of brain volume loss. Patients switching from interferon beta-1a to Zeposia experienced consistent reductions in WBV loss, with similar findings for thalamic volume loss.
The safety analysis included 762 patients on continuous Zeposia treatment, showing a decrease in incident rates per 1,000 person-years for overall TEAEs, infections, opportunistic infections, and other disorders over time.
Dr. Jeffrey Cohen, a paid consultant for Bristol Myers Squibb, highlighted the importance of early treatment in MS to prevent irreversible brain volume loss and cognitive decline. He emphasized the new analyses reinforce Zeposia's safety and efficacy profile as an effective oral therapy.
Alyssa Johnsen, MD, PhD, senior vice president and head of clinical development at Bristol Myers Squibb, stated the data presented at ECTRIMS reinforces the long-term safety and efficacy of Zeposia. She mentioned the company's ongoing efforts to advance neuroscience, including the pursuit of new modalities and disease targets.
Zeposia, an oral S1P receptor modulator, is approved in various countries for the treatment of adults with relapsing forms of MS and with moderately to severely active ulcerative colitis. The drug works by reducing the migration of lymphocytes into the central nervous system, although its exact mechanism in MS is not fully understood.
This article is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol-Myers Squibb (NYSE:BMY) has been making significant strides in the pharmaceutical industry. Goldman Sachs maintained a Buy rating on the company, following an 'encouraging' update on its oncology portfolio at the European Society for Medical Oncology event. The company discussed the advancement of a treatment regimen for non-small cell lung cancer into Phase 3 trials.
Jefferies also maintained its Hold rating on Bristol-Myers Squibb, citing a 4% upside potential and raised its price target to $51.00 following positive developments related to the company's factor XIa inhibitor, milvexian.
In the realm of public offerings, 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 currently reviewing Bristol Myers Squibb's Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of unresectable hepatocellular carcinoma. Concurrently, the company is seeking approval from the European Medicines Agency to extend the use of Breyanzi for certain follicular lymphoma patients.
Finally, the company's blood thinner Eliquis has been selected by the Biden administration for price negotiations with the Medicare health program, as part of the Inflation Reduction Act's efforts to control drug prices. These are all recent developments, highlighting Bristol-Myers Squibb's ongoing activities in the pharmaceutical industry.
InvestingPro Insights
Bristol Myers Squibb (NYSE: BMY) has been making significant strides in its clinical developments, as evidenced by the recent positive results from the Phase 3 DAYBREAK trial. These advancements are not only a testament to the company's commitment to innovation in the pharmaceutical industry but also reflect on its financial health and strategic decisions which are of interest to investors.
According to the latest metrics from InvestingPro, Bristol Myers Squibb boasts a solid market capitalization of $100.34 billion, underscoring its significant presence in the market. This is further supported by a robust gross profit margin of 76.18% over the last twelve months as of Q1 2023, indicating efficient management and a strong competitive edge in its operational activities.
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