Bristol Myers Squibb Presents 56-Week Phase 3 Data in Pediatric Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) for Camzyos (mavacamten) at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions

With a consistent efficacy and safety profile through 56-weeks of follow-up, the Phase 3 SCOUT-HCM clinical trial further reinforces Camzyos as the first approved treatment for pediatric patients ≥30 kg with symptomatic oHCM

No patient treated with Camzyos experienced left ventricular ejection fraction (LVEF) <50% over the 56-week evaluation period, and no new safety signals were reported

Additional presentations will be shared at the American Heart Association’s Scientific Sessions 2026 that expand on the breadth of evidence supporting Camzyos across clinical and real-world settings in diverse patient populations

PRINCETON, N.J.--(BUSINESS WIRE)--$BMY #AHA--Bristol Myers Squibb (NYSE: BMY) today presented 56-week results from the Phase 3 SCOUT-HCM clinical trial in a late-breaker presentation at the Hypertrophic Cardiomyopathy Medical Society (HCMS) Scientific Sessions, taking place November 6, 2026, in Chicago, Illinois. The SCOUT-HCM clinical trial evaluated the efficacy and safety of Camzyos (mavacamten) in pediatric patients aged 12 to <18 years with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). These additional data build upon confidence in Camzyos, which has the broadest indication of any cardiac myosin inhibitor (CMI) and is the first CMI approved for pediatric patients with symptomatic oHCM. Results from the 56-week data are consistent with previously reported 28-week results from the trial. Bristol Myers Squibb will be sharing additional presentations that add to the breadth of clinical and real-world data supporting the use of Camzyos across patient populations, reinforcing the consistent efficacy and safety profile of Camzyos as a treatment for symptomatic oHCM, at the American Heart Association’s Scientific Sessions 2026 taking place November 6 – 9, 2026, in Chicago, Illinois.

“These results are significant as they build upon the understanding of the meaningful impact of Camzyos in pediatric patients with symptomatic oHCM, evaluated in a 56-week study that included a 28-week placebo-controlled period. This is the first time a cardiac myosin inhibitor has been evaluated in this patient population for this length of time and in a double-blind study,” said Cordula Wolf, MD, Associate Professor, Technical University of Munich (TUM) University Hospital German Heart Centre. “These results serve as an important resource for healthcare providers and patients when discussing their care plan and the potential of Camzyos, the first approved treatment option for pediatric patients in the U.S. with symptomatic oHCM.”

SCOUT-HCM is a randomized, double-blind, placebo-controlled Phase 3 trial that evaluated Camzyos compared to placebo in pediatric patients aged 12 to <18 years old with symptomatic oHCM. Of the 44 randomized participants, 43 (mavacamten, n=23; placebo, n=20) completed the double-blind placebo-controlled period and entered the active treatment period. At week 28, all 43 patients who completed the double-blind placebo-controlled period were assigned Camzyos through week 56. Patients across both trial arms (mavacamten-mavacamten and placebo-mavacamten) achieved significant reductions in Valsalva left ventricular outflow tract (LVOT) gradient. Patients in the mavacamten-mavacamten arm experienced a mean change from baseline of -48.1 mmHg after 56 weeks of treatment. A similar degree of gradient reduction was observed in the placebo group after switching to mavacamten. Patients in both study arms showed meaningful improvements in several secondary endpoints, with no new safety signals reported.

Camzyos demonstrated a safety profile that was consistent with previously reported results for the SCOUT-HCM clinical trial, as well as previously reported Phase 3 studies evaluating Camzyos in an adult population. Treatment-related treatment-emergent adverse events (TEAEs) and serious TEAEs were low, with five and two events, respectively, reported in the mavacamten-mavacamten arm over 56 weeks of treatment, and one and zero events, respectively, reported in the placebo-mavacamten arm over 28 weeks of treatment. Over the 56-week period, no patient in the trial had experienced left ventricular ejection fraction (LVEF) <50%.

“Symptomatic oHCM is a serious condition for which having effective and safe treatments is crucial. These additional SCOUT-HCM results provide added confidence in Camzyos to healthcare providers as they consider treatment options for their pediatric patients with oHCM,” said Cristian Massacesi, MD, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “BMS is committed to researching and developing new treatments to address cardiovascular disease. The data presented at these congresses helps us better understand symptomatic oHCM and the role of Camzyos in delivering more meaningful outcomes for patients and their families.”

Additional presentations at the American Heart Association’s Scientific Sessions add to the growing body of evidence supporting the efficacy and safety profile for Camzyos as a treatment option for adult patients with symptomatic oHCM. Two presentations build upon the evidence demonstrating the effectiveness and safety profile of Camzyos with long-term use. Data presented from the Camzyos Risk Evaluation and Mitigation Strategy (REMS) program after four years of follow up showed safety findings consistent with those observed in clinical trials. In a cardiac magnetic resonance (CMR) analysis of the EXPLORER cohort of the MAVA-LTE study, favorable changes in measures of cardiac structure and function were observed over up to five years of follow-up. An analysis of the EXPLORER-HCM study evaluating the impact of Camzyos treatment on a proteomic cardiovascular (CV) risk score, which has previously been reported to predict cardiovascular risk over 4 years, showed that Camzyos reduced the CV Risk SomaSignal^® Test (SST) score in adult patients with oHCM. An analysis of MARVEL-HCM provided real-world insights on the impact of Camzyos use stratified by sarcomere gene variant status, with effectiveness and safety results that were consistent across variant-positive and variant-negative subgroups.

Camzyos was approved for the treatment of pediatric patients weighing 30 kg (66 lbs) or more with symptomatic oHCM to improve functional capacity and symptoms by the U.S. Food and Drug Administration (FDA) in September 2026. The FDA approval was based on positive 28-week results from the Phase 3 SCOUT-HCM clinical trial. Camzyos was first approved by the FDA in 2022 for the treatment of adults with symptomatic NYHA class II-III oHCM. Camzyos is supported by the largest body of worldwide evidence in the CMI treatment class.

About the Phase 3 SCOUT-HCM Trial^1,2,3

SCOUT-HCM (NCT06253221) is a Phase 3 randomized, double-blind, placebo-controlled, international trial that enrolled 44 pediatric patients (12 years to <18 years old) with symptomatic oHCM. The trial includes three treatment periods totaling up to 200 weeks: a 28-week placebo-controlled period, followed by a 28-week active-treatment period (when patients randomized to placebo cross over to Camzyos), and an open-label long-term extension period for up to 144 weeks. At baseline, 83% and 86% of patients were receiving beta blockers, 13% and 10% were receiving calcium channel blockers, and 17% and 24% were receiving disopyramide, in the Camzyos and placebo groups, respectively. Mean LVEF was 69.0% in the Camzyos group and 67.4% in the placebo group; mean Valsalva LVOT gradient was 78 mmHg in the Camzyos group and 81 mmHg in the placebo group. Patients were randomized in a 1:1 ratio and administered either Camzyos, starting dose of 2.5 mg Camzyos for body weight 35 to <45 kg, 5 mg Camzyos for body weight ≥45 kg, or placebo, once daily for 28 weeks. Dose adjustment was based on clinical echocardiogram parameters.

The primary endpoint was change from baseline to Week 28 in Valsalva LVOT gradient (mmHg). Secondary endpoints (descriptive only) included change from baseline to Week 28 in efficacy parameters of resting and postexercise LVOT gradients, peak oxygen consumption (proportion of patients achieving an increase from baseline in pVO₂), symptoms (proportion of patients with at least 1 NYHA Class improvement) and HCM Symptom Questionnaire Shortness of Breath domain (HCMSQ SoB), plus safety and pharmacokinetic parameters.

About CAMZYOS^® (mavacamten)

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. CAMZYOS is supported by the largest body of worldwide evidence in the CMI treatment class, with approvals resulting from several phase III clinical trials (EXPLORER-HCM, VALOR-HCM, SCOUT-HCM, as well as HORIZON-HCM in Japan and EXPLORER-CN in China), and up to five years of follow up in multiple pivotal trial long-term extensions (EXPLORER-LTE, VALOR-HCM LTE), providing additional data on the consistent and sustained results for CAMZYOS to improve symptoms and impact cardiac structure and function.

In the U.S., CAMZYOS is indicated for the treatment of symptomatic oHCM to improve functional capacity and symptoms in adults and pediatric patients weighing 30 kg (66 lbs) or more. 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 has been prescribed by more than 5,000 healthcare providers (HCPs) to over 25,000 adult patients in the U.S. alone.

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IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:

• Strong CYP2C19 inhibitors
• Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS Program.

CONTRAINDICATIONS

CAMZYOS is contraindicated with concomitant use of:

• Strong CYP2C19 inhibitors
• Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

WARNINGS AND PRECAUTIONS

Heart Failure

CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.

Assess the patient’s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.

Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.

Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

CYP450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness

CAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.

Advise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.

CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program

CAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:

• Prescribers must be certified by enrolling in the REMS Program
• Patients must enroll in the REMS Program and comply with ongoing monitoring requirements
• Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS
• Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at www.CAMZYOSREMS.com or by telephone at 1-833-628-7367.

Embryo-Fetal Toxicity

CAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.

ADVERSE REACTIONS

In the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM. The safety of CAMZYOS in pediatric patients (≥35 kg) was evaluated in SCOUT-HCM. There were no new adverse reactions compared to those identified in adult studies.

Effects on Systolic Function

In the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.

DRUG INTERACTIONS

Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS

CAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.

Impact of Other Drugs on CAMZYOS:

• Strong CYP2C19 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated
• Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers: Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated
• Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dosage in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 mg to 10 mg, 10 mg to 5 mg, 5 mg to 2.5 mg, or 2.5 mg to 1 mg [pediatric dosing]) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on the lowest recommended dose of CAMZYOS. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.
• Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. Initiate CAMZYOS at one dose level below the recommended starting dose in patients who are on stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 mg to 10 mg; 10 mg to 5 mg; 5 mg to 2.5 mg; or 2.5 mg to 1 mg [pediatric dosing]) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on the lowest recommended dose of CAMZYOS. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy.

Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs

CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in the Prescribing Information.

Certain Combined Hormonal Contraceptives (CHCs): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) during concomitant use and for 4 months after the last dose of CAMZYOS.

Drugs That Reduce Cardiac Contractility

Expect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.

If concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.

SPECIFIC POPULATIONS

Pregnancy

CAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com.

Lactation

The presence of CAMZYOS in human or animal milk, the drug’s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Confirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of CAMZYOS.

Please see U.S. Full Prescribing Information, including Boxed WARNING.

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