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Bristol Myers Squibb Presents New Pooled Interim Long-Term Safety and Metabolic Outcomes Data from the EMERGENT Program Evaluating KarXT in Schizophrenia at the 2024 Annual Congress of the Schizophr
KarXT demonstrated a favorable long-term metabolic profile where most patients experienced stability or improvements on metabolic parameters over 52 weeks of treatment
A majority of patients (65%) experienced reductions in weight over the course of the trial, with a mean weight decrease of 2.6kg observed at one year
Data show no significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks
KarXT was generally well tolerated, with a side effect profile consistent with prior trials of KarXT in schizophrenia
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol Myers Squibb (NYSE: BMY) today announced interim long-term safety, tolerability and metabolic outcomes data from its Phase 3 EMERGENT program evaluating KarXT (xanomeline-trospium) in adults with schizophrenia. These data were presented in a poster titled, Long-Term Safety of KarXT (Xanomeline and Trospium) in Schizophrenia (Poster F74) and in the Oral Session Long-Term Metabolic Outcomes Associated With KarXT (Xanomeline and Trospium): Interim Results From Pooled, Long-Term Safety Studies EMERGENT-4 and EMERGENT-5 at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
These long-term safety results and metabolic outcomes from the EMERGENT program are extremely encouraging, allowing us to further understand the tolerability profile of KarXT in people living with schizophrenia, said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers (NYSE:) Squibb. It is promising to see that over one year of treatment, KarXT was not associated with burdensome side effects, specifically weight gain and metabolic dysfunction, as well as extrapyramidal symptoms, which underscores its potential to provide a meaningful and differentiated option for people living with schizophrenia.
Pooled Interim Long-Term Metabolic Outcomes Associated with KarXT (EMERGENT-4 and EMERGENT-5)
The EMERGENT-4 and EMERGENT-5 trials are Phase 3, outpatient, 52-week, open-label trials evaluating the safety, tolerability, and efficacy of KarXT in adults with schizophrenia. At the time of the data cutoff of August 18, 2023, the interim pooled data analysis included 718 patients who received at least one dose of KarXT, with 134 patients having completed one year of treatment.
In the pooled analysis, KarXT demonstrated a favorable impact on weight and long-term metabolic profile where most patients experienced stability or improvements on key metabolic parameters over 52 weeks of treatment. The majority of patients (65%) experienced an overall reduction in weight over the course of the trial, with more patients (18%) experiencing potentially clinically significant ( ‰¥7% change) decreases in weight vs. 4% of patients experiencing increases in weight ( ‰¥7% change). In patients who completed 52 weeks of treatment with KarXT, an average reduction in weight of 2.6kg was observed, with a larger mean reduction in weight of 4.1kg observed in clinically obese patients (BMI > 30 kg/m2). Total cholesterol, triglyceride and HbA1c levels did not meaningfully change over one year of treatment.
Interim Long-Term Pooled Safety Outcomes Associated with KarXT (EMERGENT-4 and EMERGENT-5)
In the long-term studies, KarXT was generally well-tolerated across 52 weeks of treatment, with a side effect profile consistent with prior trials of KarXT in schizophrenia. The overall discontinuation rate in the trial was 53% and primary reasons for discontinuation included withdrawn consent (19%), treatment-related adverse events (15%), participant lost to follow-up (8%), and participant failed to adhere to protocol requirements (7%).
Across the long-term EMERGENT trials, 62% of participants reported at least one treatment-related adverse event. The most common treatment-related adverse events ( ‰¥5%) were nausea, vomiting, constipation, dry mouth, dyspepsia, dizziness, hypertension, and diarrhea, of which nearly all were mild or moderate in severity and transient in nature.
KarXT was not associated with significant changes related to prolactin or clinically meaningful changes in movement disorder scale scores over 52 weeks.
People living with schizophrenia and their care partners have long carried the burden of the condition, with a lack of treatment options that adequately treat the symptoms of schizophrenia without common debilitating side effects. To see that the long-term tolerability profile of KarXT remains consistent with earlier studies, where the cholinergic side effects of KarXT remained mainly mild or moderate in severity, and were transient and resolving with continued treatment is very encouraging, said Rishi Kakar, M.D., chief scientific officer and medical director of Segal Trials and investigator in the EMERGENT program. These results are extremely promising and add to the growing body of data which suggest that, if approved, KarXT could provide a long-desired, differentiated treatment option for people living with schizophrenia.
In additional interim long-term data presented at the congress, KarXT was associated with significant improvements in symptoms of schizophrenia across all efficacy measures at 52 weeks in the EMERGENT-4 trial. Improvements in symptoms of schizophrenia continued throughout the open-label extension regardless of whether participants were previously treated with KarXT or placebo during the acute trials, EMERGENT-2 or EMERGENT-3 (Poster F264).
About KarXT
KarXT (xanomeline-trospium) is an investigational muscarinic antipsychotic in development for the treatment of schizophrenia and psychosis related to Alzheimer’s disease. Through its novel mechanism of action, KarXT acts as a dual M1/M4 muscarinic acetylcholine receptor agonist in the central nervous system, which is thought to improve positive, negative, and cognitive symptoms of schizophrenia. Unlike existing treatments, KarXT does not directly block dopamine receptors, representing a potential new approach to treating schizophrenia.
About Schizophrenia
Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels, and behaves, and affects nearly 24 million people worldwide, including 2.8 million people in the U.S. It is characterized by three symptom domains: positive symptoms (hallucinations and delusions), negative symptoms (difficulty enjoying life and withdrawal from others), and cognitive impairment (deficits in memory, concentration, and decision-making). In part due to limitations with current treatments, people living with schizophrenia often struggle to maintain employment, live independently, and manage relationships. While current treatments can be effective in managing select symptoms, approximately 30% of people do not respond to therapy, with an additional 50% experiencing only a partial improvement in symptoms or unacceptable side effects.
Bristol Myers Squibb: Delivering Breakthrough Science for Meaningful Interventions in Neuroscience
Neurological conditions represent some of the greatest challenges of our time because of their impact on society, including patients, caregivers, families and healthcare systems. At Bristol Myers Squibb, we are committed to advancing our robust pipeline of potential medicines for neurological disorders with the goal of modifying disease and improving quality of life. Leveraging genetics, biomarkers and predictive sciences, we target key pathways involved in the initiation and progression of neurological diseases to develop therapies with the potential to optimize patient outcomes.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook (NASDAQ:) and Instagram.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that KarXT (xanomeline-trospium) may not achieve its primary study endpoints or receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether KarXT for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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In a challenging market environment, shares of 374Water (SCWO) have touched a 52-week low, dipping to $0.71. The company, with a market capitalization of $104 million, maintains a strong liquidity position with a current ratio of 3.81 and more cash than debt on its balance sheet, according to InvestingPro data. The company, which specializes in water treatment solutions, has seen its stock price struggle significantly over the past year, reflecting a broader trend in the sector. Investors have been cautious, as evidenced by the stock’s 1-year change, which shows a substantial decline of 52.96%. InvestingPro analysis indicates the stock is currently in oversold territory, with 18 additional investment insights available to subscribers. This downturn highlights the volatility faced by environmental technology companies and raises concerns about future performance amidst uncertain market conditions. With a beta of -0.51, the stock typically moves opposite to market direction, potentially offering diversification benefits.
In other recent news, 374Water Inc. has secured approximately $12.2 million through a registered direct offering, involving the sale of common stock and warrants. The cleantech company expects the gross proceeds before fees and expenses to be around the $12.2 million mark, with D. Boral (OTC:) Capital LLC serving as the exclusive placement agent for the offering. The capital infusion is scheduled to be finalized by November 18, 2024, pending customary closing conditions.
In further developments, 374Water has initiated operations of its AirSCWO technology at the Iron Bridge Regional Water Reclamation Facility in Orlando. This marks a significant step in commercial biosolids processing, with the technology designed to efficiently process biosolids and PFAS contaminated wastes. The successful integration of the AirSCWO system into the Iron Bridge facility demonstrates the company’s capacity to destroy persistent organic pollutants, including PFAS.
The Florida Department of Environmental Protection supported the installation with a grant under the Bilateral Infrastructure Law emerging contaminant funding. Notably, CEO Chris Gannon highlighted the operational success in Orlando as crucial for showcasing the technology’s capacity to manage municipal, federal, and industrial organic waste streams at scale. The company anticipates additional commitments across the United States, including a deployment to Orange County Sanitation (CA) in 2025.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
By Alden Bentley, Samuel Indyk and Rae Wee
NEW YORK/LONDON (Reuters) -Wall Street topped off a global share rally in thin trade on Thursday as markets prepared for early Christmas Eve closes, while the dollar was buoyed by firmer Treasury yields and speculation that the Federal Reserve would slow its easing in 2025.
The was 0.47% higher in late morning trade, the rose 0.73% and the rose 0.99%.
U.S. stock trading wraps up at 1:00 p.m. EDT/1800 GMT, and the bond market closes at 2:00 p.m. Most financial centers around the world are closed on Wednesday for Christmas. The U.S. reopens on Thursday, while many financial centers have a second day off.
“Meagre news and data flow should keep the focus on a more hawkish Fed,” said Ipek Ozkardeskaya, senior analyst at Swissquote Bank.
MSCI’s gauge of stocks across the globe went up more than half a percent. The pan-European index rose 0.18%. 100 rose 0.19% and 40 rose 0.14%. German stocks were closed for the Christmas holiday.
In Asia, Chinese stocks rose after sources told Reuters that Beijing planned to issue a record amount of special treasury bonds next year as it ramps up fiscal stimulus to revive a faltering economy.
The blue-chip index and both ended 1.3% higher. Hong Kong’s advanced 1.1%.
The news came shortly after China’s finance ministry said authorities would ramp up fiscal support for consumption next year by raising pensions and medical insurance subsidies for residents, as well as expanding consumer goods trade-ins.
Still, investors remain cautious on the outlook for the world’s second-largest economy, particularly as it faces the threat of hefty tariffs from U.S. President-elect Donald Trump.
Elsewhere, MSCI’s broadest index of Asia-Pacific shares outside Japan rose 0.37%.
FED FOCUS
Investors are taking direction from last week’s 25 basis point Fed interest rate cut, its signals on the strength of the economy and its slow progress bringing inflation down to its 2% target. Markets are now pricing in about 35 basis points of easing for 2025, implying one quarter-point rate cut and around a 40% chance of a second.
U.S. Treasury yields pared gains after the Treasury saw solid demand for a $70 billion sale of five-year notes, but remained higher on the day. The two-year Treasury yield, which is sensitive to changes in Fed rate expectations, was up 0.9 bp at 4.359%, while the benchmark 10-year yield rose 2.6 bp to 4.625%, reaching a seven-month high at 4.629%. [US/]
“Like markets, the Fed will need to consider U.S. policies on tariffs and immigration in its inflation and growth outlook. We believe the subtle slowing in the U.S. labor market will still be the Fed’s paramount concern,” said analysts at Citi Wealth.
“While always uncertain, our base case expectation for a 3.75% policy rate is unchanged. It’s a far cry from the 1.7% U.S. policy rate average of the past 20 years.”
The Fed’s cut was the third one this cycle, taking the Fed funds rate to 4.25%-4.5%.
Ahead of Trump’s return to the White House in January, global central banks have urged caution over their rate paths due to uncertainty on how his planned tariffs, lower taxes and immigration curbs might affect policy.
Data on Monday showed U.S. consumer confidence unexpectedly weakened in December as the post-election euphoria fizzled and concerns about future business conditions emerged.
In currencies, the rose 0.14% hovering near a two-year high hit Monday, having climbed more than 2% in December so far.
The euro eased 0.15% to $1.0389, while the yen languished near last week’s five-month low, trading at 157.35 per dollar.
Japan’s Finance Minister Katsunobu Kato on Tuesday reiterated Tokyo’s discomfort with excessive foreign exchange moves and put speculators on notice that authorities are ready to act to stabilise a faltering yen.
rose 0.13% to $2,616.26 an ounce, having risen about 27% this year, heading for its biggest yearly gain since 2010.
rose 1.56% to $70.32 a barrel and rose to $73.73 per barrel, up 1.51% on the day. [O/R]
By David French
(Reuters) -Wall Street’s main indexes all ended higher on Tuesday, with gains in megacap and growth stocks bolstering benchmarks in a truncated Christmas Eve session.
Both the and the scored four straight sessions of gains. For the Dow, the run follows its 10-session skid earlier this month, its longest losing streak since 1974.
The benchmarks closed higher on the first day of a historically strong period called the “Santa Claus rally.” The on average has gained 1.3% in the last five days of December and first two days of January, according to data from the Stock Trader’s Almanac going back to 1969.
With megacap stocks having outsized influence on markets, their performance is often a key driver of indexes. When coupled with reduced trading volumes and few other catalysts, as many investors take time off for the holidays, this is even more pronounced.
All the so-called Magnificent Seven megacap technology stocks climbed on Tuesday, led by Tesla (NASDAQ:).
The automaker’s rise helped push consumer discretionary shares higher, making them the top gaining sector in the S&P.
Elsewhere, chip manufacturers were also buoyant. Broadcom (NASDAQ:) and Nvidia (NASDAQ:) were up, while Arm Holdings (NASDAQ:) climbed a day after losses from losing a court case.
Growth names rose despite U.S. Treasury interest rates remaining elevated – the benchmark 10-year note yielded around 4.61% on Tuesday. Traditionally, higher debt costs crimp growth stocks.
However, the long-term themes around technology development, including advancements in artificial intelligence, overshadow any near-term moves in Treasuries, said Charlie Ripley, senior investment strategist for Allianz (ETR:) Investment Management.
“This reinforces that view that the sector is going to remain strong, and should be well into the new year,” he said.
According to preliminary data, the S&P 500 gained 64.93 points, or 1.09%, to end at 6,039.00 points, while the Nasdaq Composite gained 264.31 points, or 1.34%, to 20,029.19. The Dow Jones Industrial Average rose 366.75 points, or 0.85%, to 43,273.70.
Stock markets shut at 1:00 p.m. ET on Tuesday and will be closed for Christmas on Wednesday.
After a stellar run to record highs following the November election, which sparked hopes of pro-business policies under U.S. President-elect Donald Trump, Wall Street’s rally hit a bump this month as investors grappled with the prospect of higher interest rates in 2025.
The U.S. Federal Reserve eased borrowing costs for the third time this year last Wednesday, but signaled only two more 25-basis-point reductions next year, down from its September projection of four cuts, as policymakers weigh the possibility of Trump’s policies stoking inflation.
Allianz’s Ripley said the themes which had driven the market higher in the past two months remained intact, and actions by the Fed had not killed the rally.
“Heading into 2025, things are set up with good positioning,” he said, noting factors including economic outlook, consumption in the U.S. and the labor market.
Crypto-related stocks traded higher on Tuesday, including Microstrategy (NASDAQ:), Riot Platforms (NASDAQ:), and MARA Holdings, as the price of bitcoin advanced.
NeueHealth soared after the healthcare provider said New Enterprise Associates, its largest shareholder, and a group of existing investors will take the company private in a $1.3 billion deal.
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