PRINCETON, N.J. - Bristol Myers Squibb (NYSE: BMY) has released new data from its Phase 3 EMERGENT-4 and EMERGENT-5 trials, demonstrating sustained improvements in schizophrenia symptoms over a 52-week period with COBENFY™ (xanomeline and trospium chloride) treatment. The findings were presented at the 2024 Psych Congress held from October 29 to November 2 in Boston, MA.
The long-term trials indicated that COBENFY maintained its efficacy in reducing schizophrenia symptoms such as hallucinations, delusions, and social withdrawal. The EMERGENT-4 trial, an open-label extension study, included 156 adults who had completed earlier trials. Results showed that 69% of participants who completed the study achieved a ≥30% improvement in schizophrenia symptoms from acute trial baseline, as measured by the Positive and Negative Syndrome Scale (PANSS) total score.
COBENFY was generally well-tolerated with a side effect profile consistent with prior studies. The most common treatment-emergent adverse events (TEAEs) included nausea, vomiting, dyspepsia, dry mouth, and hypertension, with the majority being mild to moderate in intensity. The discontinuation rate due to TEAEs in EMERGENT-4 was 11%.
The EMERGENT-5 trial evaluated COBENFY's long-term safety and efficacy in 566 adults with stable symptoms on prior antipsychotics. At week 52, 30% of participants had a ≥30% reduction from baseline in the PANSS total score. The discontinuation rate due to TEAEs in this trial was 18%.
Additionally, COBENFY was not associated with weight gain, movement disorders, or metabolic changes over the 52-week treatment period. In-trial interviews from the EMERGENT-5 study also revealed that most participants reported Quality of Life improvements across physical, social, emotional, and role functioning domains.
These results support COBENFY's differentiated profile and its potential as a long-term treatment option for adults with schizophrenia. The information in this article is based on a press release statement from Bristol Myers Squibb.
In other recent news, Bristol-Myers Squibb (NYSE:BMY) (BMS) reported robust growth in its third-quarter earnings, with a significant 20% increase in its growth portfolio revenues, now accounting for about half of the total revenues. The company's disciplined expense management and solid demand across its product portfolios were key contributors to this performance. BMS also highlighted the FDA approval of Cobenfy, a novel schizophrenia treatment, and positive advancements in oncology, including new registration opportunities.
Additionally, BMS acquired Karuna Therapeutics (NASDAQ:KRTX) to enhance long-term growth, with ongoing trials in schizophrenia and Alzheimer's. The company is actively working towards achieving $1.5 billion in cost savings and aims to reduce $10 billion in debt by mid-2026. Furthermore, the company raised its full-year revenue and non-GAAP EPS guidance due to strong year-to-date results.
BMS plans to initiate three Phase 3 studies in 2024 and present Phase 1 data for CD19 NEX-T cell therapy. However, the company also faces challenges from generic competition on drugs like Sprycel and Pomalyst. Despite these challenges, BMS reported strong demand and double-digit growth for key products such as Eliquis and Camzyos, demonstrating its commitment to growth and innovation.
InvestingPro Insights
Bristol Myers Squibb's (NYSE: BMY) recent positive data from its COBENFY™ trials aligns with the company's strong position in the pharmaceutical industry. According to InvestingPro data, BMY boasts a substantial market capitalization of $106.76 billion, underscoring its significant presence in the market.
The company's focus on innovative treatments like COBENFY™ for schizophrenia is reflected in its robust financial performance. BMY reported a revenue of $46.51 billion in the last twelve months as of Q2 2024, with a notable revenue growth of 8.69% in the most recent quarter. This growth trajectory supports the company's ability to invest in and develop breakthrough therapies.
InvestingPro Tips highlight that BMY has maintained dividend payments for 54 consecutive years, demonstrating a commitment to shareholder returns. This is particularly relevant given the company's current dividend yield of 4.56%, which may attract income-focused investors interested in the long-term potential of BMY's drug pipeline.
Moreover, BMY's stock is trading near its 52-week high, with a price that is 99.02% of its 52-week peak. This could indicate market confidence in the company's recent developments and future prospects, including the potential success of treatments like COBENFY™.
For investors seeking more comprehensive analysis, InvestingPro offers additional tips and insights. Currently, there are 11 more InvestingPro Tips available for BMY, providing a deeper understanding of the company's financial health and market position.
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