Mavacamten

New single-arm, open-label data extend the body of evidence supporting consistent clinical benefit and safety with Camzyos, adding to the longest-running clinical development experience for a cardiac myosin inhibitor (CMI) in symptomatic oHCM Additional presentations at ESC Congress build upon the established effectiveness and safety pro Camzyos in real-world settings Bristol Myers Squibb (NYSE: BMY) today presented results from the EXPLORER-LTE cohort of the MAVA-LTE study (NCT03723655) in a late-breaker presentation at the European Society of Cardiology (ESC) Congress 2026 in Munich, Germany. EXPLORER-LTE is the largest and longest evaluation of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) patients treated with Camzyos, the most-studied cardiac myosin inhibitor (CMI) and a standard of care for patients with oHCM in New York Heart Association (NYHA) class II-III. These data add to the understanding that the effects of Camzyos are sustained for up to five years with continuous, consistent treatment. Additional presentations at ESC Congress from COLLIGO-HCM, a global retrospective real-world data study, add to the well-established real-world evidence supporting Camzyos, helping inform treatment decisions for people living with the condition. “The EXPLORER-LTE data up to five years reflect the sustained and clinically meaningful effects of Camzyos for patients living with symptomatic oHCM,” said Anjali T. Owens, MD, Medical Director of the Center for Inherited Cardiac Disease and an Associate Professor of Medicine in the Perelman School of Medicine at the University of Pennsylvania. “For a chronic, progressive condition that requires ongoing treatment and monitoring, long-term evidence is essential to helping clinicians better understand how a therapy may benefit patients over time.” EXPLORER-LTE is a single-arm, open-label, dose-blinded extension of the Phase 3 EXPLORER-HCM study, evaluating the long-term safety and efficacy of Camzyos. A total of 231 patients who completed EXPLORER-HCM enrolled in the long-term extension study. A substantial portion of patients experienced sustained and clinically meaningful reduction of left ventricular outflow tract (LVOT) obstruction, improved by at least one NYHA class and experienced notable improvements in echocardiographic measures and biomarkers. No new safety signals were observed that were not observed in the primary EXPLORER-HCM study. At 252 weeks, Camzyos treatment resulted in mean changes from baseline at initiation of the long-term extension study of -38.7 mm Hg for resting LVOT gradient and -55.6 mm Hg in Valsalva LVOT gradient. Nearly all patients (97.4%) achieved a Valsalva LVOT gradient ≤ 30 mm Hg, which is the threshold for obstruction in patients with oHCM. 69.6% of patients improved by ≥1 NYHA class and 59.2% of patients were asymptomatic. Mean left ventricular ejection fraction (LVEF) decreased by 10.2% and remained within the normal range. Safety findings were consistent with reported results from the primary EXPLORER-HCM study. Additional data presented at ESC Congress further support Camzyos and our understanding of the impact of oHCM. Two presentations from COLLIGO-HCM, a global retrospective real-world data study, added to the well-established real-world evidence supporting Camzyos in clinical practice, with a real-world effectiveness and safety pro is consistent across patients, providing symptom improvement and reduction in LVOT obstruction. A complementary analysis of a real-world observational registry study in Germany reinforces the effectiveness of Camzyos across geographic populations, with patients achieving NYHA class reductions consistent with previously reported real-world studies. These findings build on the existing evidence base for Camzyos and reinforce that the improvements seen in clinical trials are also achieved in real-world settings. An additional analysis of a healthcare resource utilization (HCRU) study in Sweden adds to the understanding of the broader disease burden of HCM and oHCM, including the increased impact of oHCM, and emphasizes the importance of accurate diagnosis and consistent care for patients living with oHCM. “For people living with symptomatic oHCM, long-term and real-world evidence provides greater confidence in treatment decisions and a clearer understanding of what sustained therapy may mean over time,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “As part of our dedication to advancing cardiovascular research, the data presented at ESC Congress add to the understanding and trust of Camzyos and its role in helping patients manage oHCM, a serious condition affecting daily activities for many patients.” Camzyos is supported by the largest body of worldwide evidence in the CMI treatment class, reinforcing its role in transforming care for symptomatic oHCM by improving functional capacity and symptoms, allowing patients to be more active in their daily lives. EXPLORER-LTE, a cohort of the MAVA-LTE study (NCT03723655), is a single-arm, open-label, dose-blinded extension of the Phase 3 EXPLORER-HCM study evaluating the long-term safety and efficacy of Camzyos. CAMZYOS® (mavacamten) is the most extensively studied cardiac myosin inhibitor (CMI), approved by regulatory bodies in more than 60 countries and regions across five continents worldwide. In the U.S., CAMZYOS is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. In the European Union, CAMZYOS is indicated for the treatment of symptomatic (NYHA, class II-III) oHCM in adult patients. A selective, reversible, allosteric inhibitor of cardiac myosin, CAMZYOS targets hypercontractility, the source of oHCM. Reduction in cardiac contractility with CAMZYOS treatment leads to reduced LVOT obstruction, improved energy consumption, and lower cardiac filling pressures in oHCM patients. These effects have translated to demonstrated symptom improvements in clinical studies for adults with symptomatic oHCM, enabling them to be more active in their daily lives. CAMZYOS can be used with or without background therapies, including for newly diagnosed patients. CAMZYOS is supported by the largest body of worldwide evidence in the CMI treatment class, with up to five years of follow up across multiple long-term evidence and real-world studies, demonstrating the consistent and sustained benefits of CAMZYOS to improve symptoms and impact cardiac structure. CAMZYOS has been prescribed by more than 5,000 healthcare providers (HCPs) to over 25,000 patients in the U.S. alone. Bristol Myers Squibb is inspired by a single vision – transforming patients’ lives through science. Cardiovascular disease is the leading cause of death worldwide, and despite major advances in how we prevent and treat it, the human and societal burden continues to worsen over time. Whether a cardiovascular disease that affects millions of people around the world, or a rarer condition, the need is the same: new and better treatment options that allow people to continue to live their fullest lives. Bristol Myers Squibb is committed to developing new treatments to address the global burden of cardiovascular disease. Building on our 70-year legacy of discovering and delivering paradigm-changing cardiovascular medicines, we are leveraging our experience and expertise, to take cardiovascular research to the next level and delivering meaningful, life‑changing outcomes for patients. At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. 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iStock, Afry Harvy BMS is barreling toward a clinical trial readout that an H.C. Wainwright analyst believes could contribute to the return of mergers between mega-cap drugmakers. The collapse of AstraZeneca’s reported merger talks with Bristol Myers Squibb extended the long wait for a deal between two major drugmakers and deprived BMS of one possible solution to growth problems that could be compounded soon if a key upcoming readout does not meet expectations. Analysts saw merging with AstraZeneca as a way for BMS to manage its patent cliff. About 80% of the company’s revenue base will face generic or biosimilar competition by 2031, Raghuram Selvaraju, senior healthcare equity research analyst at H.C. Wainwright & Co., told BioSpace via email. Unless the oral FXIa inhibitor milvexian succeeds in the clinic and offsets lost sales, Selvaraju believes BMS may face challenges that could have implications across the Big Pharma landscape. “We think that consolidation among the weaker large-cap companies is inevitable. If BMS blows up with milvexian, there may be a feeding frenzy once the carnage is over and the dust settles,” Selvaraju said. “Other companies that could be the subject of takeover speculation include the weakest of the traditional large-caps, namely GSK and Pfizer.” M&A No deal between AstraZeneca and BMS, senior source insists: Reuters Reuters has deflated rumors that AstraZeneca and Bristol Myers Squibb are discussing a possible merger, letting the air out of industry-wide speculation over what could have been the largest deal in pharma history. August 5, 2026 · 1 min read · Gabrielle Masson Read more BMS’ binary event Selvaraju sees LIBREXIA AF, a Phase 3 trial of milvexian in atrial fibrillation, as the key readout for BMS’ future, regardless of whether the company delivers positive results elsewhere in its portfolio. BMS expects to report LIBREXIA AF data next year. Milvexian has become a risky prospect, given the previous failure of the LIBREXIA ACS pivotal program for reducing cardiovascular risk and prior setbacks in stroke, Selvaraju said. Bayer’s rival oral FXIa inhibitor, asundexian, also failed to reduce the risk of stroke in atrial fibrillation, leading the German drugmaker to end the trial in 2023. Noting the readthrough from Bayer’s failure, Selvaraju said it is “not totally clear” why there remains “significant faith in milvexian.” In an email to BioSpace , Seamus Fernandez, senior managing director at Guggenheim Securities, put milvexian’s chances of success in the atrial fibrillation trial at 60%. Milvexian has a 70% chance of succeeding in a secondary stroke prevention study, Fernandez said. BMS does not currently have sufficient backup programs to weather the possibility of milvexian failing in Phase 3, Selvaraju said. If milvexian is totally written off, BMS’ share price could fall 40% to 50% from its current levels, the analyst added. “If milvexian fails in atrial fibrillation, that leaves a gaping hole in the portfolio and a revenue base void that could prove impossible to fill, with significant top-line sales attrition likely to occur in 2029 through the early 2030s,” Selvaraju said. BMS reported Eliquis and Opdivo revenues of $8.6 billion and $4.6 billion, respectively, in the first half of 2026. The drugs accounted for more than half of BMS’ sales. Selvaraju predicts the entire Eliquis revenue base could be erased by 2030, reflecting expectations that generics will start to erode sales quickly when the patent expires later this year. The company is working to hold on to a larger share of Opdivo sales for longer. Not only does Opdivo have a couple extra years of exclusivity, going off patent in 2028, but biosimilars typically take longer to win market share than generics. BMS aims to further dull the impact of biosimilars by driving uptake of its subcutaneous product, Opdivo Qvantig. H.C. Wainwright analysts model Opdivo sales falling from about $11 billion in 2027 to less than $5 billion by 2030. Biosimilars “are likely to eat into Opdivo sales relatively quickly,” Selvaraju said, because BMS lacks “a clear life cycle management strategy” and Qvantig will only partly cushion the blow. Selvaraju added that “Opdivo has been getting creamed by Keytruda in the checkpoint inhibitor wars for years.” Life beyond milvexian BMS’ LPA1 antagonist admilparant is widely seen as another important R&D program. The pulmonary fibrosis drug candidate is “probably the most exciting and high-probability prospect” in the company’s clinical pipeline, Selvaraju said. BMS aims to publish Phase 3 data for the asset in idiopathic pulmonary fibrosis this year, with results in progressive pulmonary fibrosis due in 2027. Boehringer Ingelheim’s Jascayd has set the bar in these indications. Selvaraju predicts that BMS can dominate the markets if admilparant matches Jascayd’s “relatively low” efficacy benchmark and meets the “readily achievable” goal of improving on the drug’s safety and tolerability. In that scenario, peak annual sales of admilparant could exceed $3 billion. Fernandez is bullish on the drug candidate, telling investors to “watch the extraordinary launch of Jascayd as a benchmark for just how poorly served the market is.” The Guggenheim analyst sees the U.S. market growing to “well over” $30 billion at peak and values the admilparant opportunity at more than $5 billion. Admilparant could join Camzyos and Breyanzi among BMS’ key commercial products. Heart disease drug Camzyos “has particularly strong long-term sales potential given its first-in-class status and favorable positioning following recent label expansions,” Selvaraju said. The H.C. Wainwright analyst said the cell therapy Breyanzi is an underappreciated asset and an “eminently defensible” franchise. Selvaraju is more downbeat on Cobenfy, the schizophrenia treatment that BMS acquired in its $14 billion takeover of Karuna Therapeutics. Turning Cobenfy into a blockbuster will be challenging, the analyst said, and “label expansion into the elderly Alzheimer’s disease population shall be difficult due to the well-documented side effects of the drug.” BMS’ struggles to grow Cobenfy, sales of which totaled $119 million in the first half of 2026, are dialing up the pressure on the rest of the business. Drug candidates such as lymphoma prospect golcadomide and PD-L1/VEGF-A bispecific antibody pumitamig could take some of the slack. Yet the magnitude of the patent cliff means Selvaraju believes milvexian will be key to securing BMS’ future. Its failure, Selvaraju said, could leave BMS “hanging by a thread.” Neurodegenerative disease BMS’ neuro renaissance was built on back of Celgene mega-merger Well-known for its oncology efforts and making recent headlines for a rumored mega merger with AstraZeneca, Bristol Myers Squibb is also dedicating considerable resources to neurological and psychiatric diseases, with a “continuum of care” mindset. August 31, 2026 · 7 min read · Heather McKenzie Read more