Delving into the Latest Updates on Mavacamten with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

MAVA, MAVA-Myokardia, BMS-986427

+ [8]

Target

Cardiac myosin

Action

inhibitors

Mechanism

Cardiac myosin inhibitors

Therapeutic Areas

Cardiovascular Diseases

Active Indication

Hypertrophic obstructive cardiomyopathyHypertrophic Cardiomyopathy without ObstructionHeart failure with normal ejection fraction+ [1]

Inactive Indication-

Originator Organization

Bristol Myers Squibb Co.

Active Organization

Bristol Myers Squibb Co.

MyoKardia, Inc.

Shanghai Lianbio Development Co., Ltd.

+ [4]

Inactive Organization-

License Organization

LianBio

Sanofi

MyoKardia, Inc.

+ [2]

Drug Highest PhaseApproved

First Approval Date

United States (28 Apr 2022),

Hypertrophic obstructive cardiomyopathy

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Priority Review (China), Breakthrough Therapy (China), Orphan Drug (South Korea)

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Structure/Sequence

Molecular FormulaC15H19N3O2

InChIKeyRLCLASQCAPXVLM-NSHDSACASA-N

CAS Registry1642288-47-8

This study aimed to evaluate the efficacy and safety of Mavacamten compared to no treatment in patients with symptomatic latent obstructive hypertrophic cardiomyopathy. The trial was randomized into two groups: Mavacamten group and Non-Mavacamten group. Over the 30-week treatment period, patients underwent a series of assessments at predefined time points, including transthoracic echocardiography, electrocardiogram (ECG), Holter monitoring, NYHA functional classification, Kansas City Cardiomyopathy Questionnaire (KCCQ), and cardiac biomarkers.

Start Date20 Apr 2025

Sponsor / Collaborator

Shanghai Chest Hospital

NCT06856265

/ Not yet recruitingNot ApplicableIIT

Efficacy of Mavacamten Combined With Radiofrequency Ablation in Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

This study aims to evaluate the efficacy and safety of Mavacamten combined with radiofrequency ablation compared to Mavacamten alone in patients with symptomatic obstructive hypertrophic cardiomyopathy (HOCM).
Participants were randomized into two groups:

Start Date26 Feb 2025

Sponsor / Collaborator

Shanghai Chest Hospital

NCT06146660

/ RecruitingNot Applicable

CAMZYOS® (Mavacamten) Post-Marketing Surveillance in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM)

The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.

Start Date24 Jul 2024

Sponsor / Collaborator

Bristol Myers Squibb Co.

100 Clinical Results associated with Mavacamten

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100 Translational Medicine associated with Mavacamten

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100 Patents (Medical) associated with Mavacamten

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369

Literatures (Medical) associated with Mavacamten

01 Jun 2025·ESC Heart Failure

Early genetic screening and cardiac intervention in patients with cardiomyopathies in a multidisciplinary clinic

Article

Author: Tymchak, Wayne ; Dzwiniel, Tara ; Chan, Anita Y.M. ; McAlister, Finlay A. ; Thomas, Jissy ; Gagnon, Luke R. ; Hazra, Deepan ; Sadasivan, Chandu ; Oudit, Gavin Y. ; Paterson, D. Ian ; Christian, Susan ; Wang, Kaiming ; Youngson, Erik

Abstract:

Aims:

Patients with cardiomyopathies are a heterogeneous group of patients who experience high morbidity and mortality. Early cardiac assessment and intervention with access to genetic counselling in a multidisciplinary Cardiomyopathy Clinic may improve outcomes and prevent progression to advanced heart failure.

Methods and results:

Our prospective cohort study was conducted at a multidisciplinary Cardiomyopathy Clinic with 421 patients enrolled (42.5% female, median age 58 years), including 224 patients with dilated cardiomyopathy (DCM, 42.9% female, median age 57 years), 72 with hypertrophic cardiomyopathy (HCM, 43.1% female, median age 60 years), 79 with infiltrative cardiomyopathy (65.8% female, median age 70 years) and 46 who were stage A/at risk for genetic cardiomyopathy (54.3% female, median age 36 years). Patients were seen in follow‐up at a median of 18 months. A pathogenic/likely pathogenic variant was identified in 28.5% of the total cohort, including 33.3% of the DCM cohort (28% TTN mutations) and 34.1% of the HCM cohort (60% MYBPC3 and 20% MYH7) who underwent genetic testing. The use of angiotensin‐converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitor (48.3–69.5% of total cohort, P < 0.001), β‐blockers (58.4–72.4%, P < 0.001), mineralocorticoid receptor antagonists (33.9–41.4%, P = 0.0014) and sodium/glucose cotransporter‐2 inhibitors (5.3–27.9%, P < 0.001) all increased at follow‐up. Precision‐based therapies were also implemented, including tafamidis for transthyretin amyloidosis (n = 21), enzyme replacement therapy for Fabry disease (n = 14) and mavacamten (n = 4) for HCM. Optimization of medications and devices resulted in improvements in left ventricular ejection fraction (LVEF) from 27% to 43% at follow‐up for DCM patients with reduced LVEF at baseline (P < 0.001) and reduction in left ventricular mass index (LVMI) from 156 g/m2 to 128 g/m2 at follow‐up for HCM patients with abnormal LVMI at baseline (P = 0.009). Optimization of therapies was associated with stable plasma biomarkers in stage B patients while lowering levels of BNP (619–517.5 pg/mL, P = 0.048), NT‐proBNP (777.5–356 ng/L, P < 0.001) and hsTropT (31–22 ng/L, P = 0.005) at follow‐up relative to baseline values for stage C patients. Despite stage B patients having overt cardiomyopathy at baseline, stage A and B patients had a similarly high probability of survival (χ2 = 0.204, P = 0.652). The overall cardiovascular mortality rate was low at 1.7% for the cohort (0.5% for stage B and 3.3% for stage C) over a median of 34‐month follow‐up.

Conclusion:

Our study demonstrates that a multidisciplinary cardiomyopathy clinic can improve the clinical profiles of patients with diverse genetic cardiomyopathies.

01 Jun 2025·CURRENT PROBLEMS IN CARDIOLOGY

A Multidimensional Approach to Understanding Genetic Diversity, Risk Stratification, and Personalized Interventions in Pediatric Hypertrophic Cardiomyopathy

Review

Author: Alshabrmi, Fahad M ; Al-Doaiss, Amin A ; Alwanian, Wanian M ; Alromaihi, Mona ; Thornbury, William ; Alfifi, Somayah Mohammad ; AlDuayji, Nouf Nasser ; Alrumaihi, Faris ; Khan, Shahid Ullah ; Alharbi, Hajed Obaid

Hypertrophic cardiomyopathy (HCM) in children presents unique challenges distinct from adult manifestations, with potentially devastating consequences, including sudden cardiac death. This comprehensive review synthesizes current evidence on the pathophysiology, clinical presentation, and management of pediatric HCM, highlighting critical differences from adult populations. While affecting approximately 1 in 500 individuals, pediatric HCM demonstrates more significant etiological heterogeneity, with up to 35% of cases stemming from non-sarcomeric causes, including RASopathies, metabolic disorders, and syndromic conditions. This etiological diversity contributes to variable disease trajectories and treatment responses, creating a significant research gap in pediatric-specific management protocols. Current pharmacological approaches primarily employ beta-blockers as first-line therapy, with calcium channel blockers serving as alternatives for intolerant patients. However, these conventional medications manage symptoms without addressing underlying pathophysiology or preventing disease progression. Emerging investigational therapies, including angiotensin receptor blockers and myosin inhibitors like mavacamten, show promise in preliminary studies but lack robust pediatric-specific evidence. Surgical interventions, including septal myectomy and the modified Konno procedure, demonstrate efficacy in medication-refractory cases but carry higher complication risks in younger patients. The critical research gap lies in developing targeted therapeutic approaches for pediatric-specific HCM subtypes, particularly those associated with syndromic and metabolic disorders. Additionally, risk stratification models for sudden cardiac death prevention remain inadequately validated in pediatric populations. This review identifies the urgent need for pediatric-focused clinical trials investigating both conventional and novel therapies alongside the development of age-appropriate risk assessment tools to guide personalized management strategies for this vulnerable population.

01 Jun 2025·Cardiology and Therapy

Effect of Mavacamten on Echocardiographic Features in Chinese Patients with Obstructive Hypertrophic Cardiomyopathy: Results from the EXPLORER-CN Study

Article

Author: Zhong, Yue ; Barrett, Yu Chen ; Zhang, Qing ; Li, Liwen ; Tian, Zhuang ; Chen, Yu-Mao ; Zheng, Jing ; Jin, Wei ; Yang, Ping ; Cheng, Xiang ; Wang, Jian'an ; Li, Xiaoyan ; Shi, Yunqi ; Zhang, Shuyang ; Peng, Daoquan ; Wang, Fang ; Ma, Wei

INTRODUCTION:

Mavacamten, a cardiac myosin inhibitor, has demonstrated positive outcomes in left ventricular outflow tract (LVOT) gradient reduction and improvements of symptoms and function in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in EXPLORER-CN. This exploratory analysis aimed to evaluate the effect of mavacamten on echocardiographic measures of cardiac structure and function and its relationship with other clinical biomarkers.

METHODS:

Key echocardiographic parameters acquired over 30 weeks from 81 patients (n = 54 on mavacamten and n = 27 on placebo) were assessed in a central laboratory.

RESULTS:

At 30 weeks, greater improvements in measures of diastolic function were observed with mavacamten versus placebo, including lateral E/e' (least-squares mean [LSM] change from baseline [CFB] - 5.1 vs. 0.6; between-group LSM difference - 5.7; 95% confidence interval [CI] - 7.6 to - 3.7), septal E/e' (LSM CFB - 6.0 vs. - 0.3; between-group LSM difference - 5.7; 95% CI - 7.8 to - 3.7), and left atrial volume index (LAVI) (LSM CFB - 11.7 vs. - 3.5 ml/m²; between-group LSM difference - 8.2; 95% CI - 12.0 to - 4.4) (nominal p < 0.001 for all). Twelve patients (23.1%) treated with mavacamten had complete resolution of mitral valve systolic anterior motion (SAM) versus two patients (7.4%) receiving placebo. Among mavacamten-treated patients, reductions in resting and Valsalva LVOT gradients, left ventricular (LV) mass index, LAVI, and lateral and septal E/e' were associated with reduced N-terminal pro-B-type natriuretic peptide levels (nominal p < 0.0001 for all). In the mavacamten group, reductions in LVOT gradients and LV end-diastolic interventricular septal thickness were associated with improved patient-reported Kansas City Cardiomyopathy Questionnaire Overall Summary Score (nominal p < 0.05 for all).

CONCLUSIONS:

Clinically meaningful improvements were evident in Chinese patients treated with mavacamten compared with placebo in several hallmarks of obstructive HCM, including measures of LV diastolic function, SAM, and LVOT gradient. These results add further evidence to support the positive effects of mavacamten in cardiac remodeling.

REGISTRATION:

ClinicalTrials.gov identifier: NCT05174416.

196

News (Medical) associated with Mavacamten

14 May 2025

·www.biopharmadive.com

Bluebird extends deal deadline; Affimed files for insolvency

Today, a brief rundown of news involving Bluebird bio and Affimed, as well as updates from Cytokinetics, BridgeBio Pharma and Acelyrin that you may have missed.Carlyle and SK Capital Partners, two investment firms attempting to buy Bluebird bio, have amended their offer to give Bluebird shareholders a choice of payouts. Holders of Bluebird stock can either receive $3 per share plus rights to $6.84 more if a certain sales milestone is achieved Carlyle and SK Capitals original bid or $5 per share. Shareholders previously had a deadline of May 12 to tender their stock to the original deal, but now have until May 29 to do so. Bluebirds board is in favor of accepting Carlyle and SK Capitals offer, warning investors in a statement Wednesday that, absent a deal, the company is at significant risk of default. Ned PagliaruloCancer drug developer Affimed has filed for insolvency, warning investors Tuesday that there is substantial doubt the company can sustain itself. As a result of the filing, Affimed shares will be suspended from trading on the Nasdaq stock exchange beginning May 20. The company has been talking with potential investors and partners about deals or other ways in which it might raise capital, but has so far been unsuccessful. Affimed, which has three drugs in clinical testing, last reported cash holdings of 24 million euros as of Sept. 30, 2024. Ned PagliaruloCytokinetics on Tuesday said its experimental drug aficamten outperformed beta blockers in a Phase 3 study of people with obstructive hypertrophic cardiomyopathy. U.S. regulators are already reviewing aficamtens use in the inherited heart condition, with an approval decision now expected by late December after a recent delay. The latest results, though generally expected by investors, could help boost its case with physicians and insurers, wrote RBC Capital Markets analyst Brian Abrahams. If approved, aficamten would compete for market share with Bristol Myers Squibbs Camzyos, which booked $602 million in sales last year. Ben FidlerBridgeBio Pharma has begun dosing patients in a first-of-its-kind Phase 3 trial testing whether its drug, Attruby, can prevent or delay the onset of transthyretin amyloidosis in people more likely to inherit it. The trial, ACT-EARLY, will evaluate Attruby as a prophylactic treatment in carriers of a disease-causing variant of the TTR gene thats implicated in the hereditary form of the condition. Attruby is one of three marketed drugs that can slow progression of a type of transthyretin amyloidosis that affects the heart. No medicines have been proven to prevent the disease, however. Ben FidlerShareholders in Acelyrin and Alumis voted Tuesday to combine the two biotechnology companies, ending a twisting merger saga that featured an unsolicited bid from an entity controlled by Tang Capital and a push from Trium Capital to force Acelyrin to liquidate its assets and return cash to its stockholders. Since announcing the planned combination, Alumis has tweaked the terms of the deal, saying its shareholders would own 52% of the new company, while Acelyrins would hold 48%. The merger is now set to close in the second quarter of 2025. Gwendolyn Wu '

Phase 3Acquisition

13 May 2025

·firstwordpharma.com

Cytokinetics touts fresh ammo for delayed cardiomyopathy drug in Camzyos fight

Cytokinetics said its cardiac myosin inhibitor aficamten — already under review at the FDA as a potential treatment for obstructive hypertrophic cardiomyopathy (HCM) — delivered positive topline results in another Phase III trial, this time comparing it to a commonly used beta-blocker.The new data emerged about a week after the FDA extended its timeline for a decision by three months due to the company's failure to include a Risk Evaluation and Mitigation Strategy (REMS) in its original application.The 175-patient MAPLE-HCM trial met its primary endpoint, demonstrating significant improvement in peak oxygen uptake (pVO2) from baseline to week 24 compared to metoprolol. The head-to-head comparison could help aficamten stand out against Bristol Myers Squibb's first-to-market cardiac myosin inhibitor Camzyos (mavacamten) in the obstructive HCM space.Camzyos, approved by the FDA in 2022, recently received updated labelling that reduced some of its monitoring requirements and eased certain restrictions.In a release Tuesday, Cytokinetics' R&D chief Fady Malik said the MAPLE-HCM results are "the first evidence that aficamten may be used as monotherapy," and also "provide important context to the benefit of this potential new medicine compared to the current standard of care."Cytokinetics faced investor disappointment earlier this month when the FDA pushed its decision date for aficamten from September 26 to December 26 after the agency decided that the company needs to submit a REMS, which the FDA then classified as a major amendment requiring more review time.The filing is largely based on the Phase III SEQUOIA-HCM study. FDA hasn't asked for any additional data, and Cytokinetics is "still moving forward full steam ahead" with its commercial readiness plans, a company representative told FirstWord earlier this month. See – ViewPoints: Cytokinetics' R&D head on why aficamten is worth the wait.Morgan Stanley analysts have said aficamten is likely to be approved for obstructive HCM in 2025. "We see greater upside potential from the MAPLE-HCM study, which could position aficamten in first-line therapy and provide differentiation from Camzyos," they added.

Phase 3Clinical ResultDrug ApprovalNDA

08 May 2025

·www.echemi.com

Big Pharma Q1 2025 Revenues Top $60B Despite Slumps in China and Generic Pressures

As patent cliffs loom and pricing scrutiny intensifies, pharmaceutical giants are doubling down on innovation pipelines and international expansion. The first quarter of 2025 saw mixed results among major players like Merck, Roche, Sanofi, Bristol Myers Squibb (BMS), and Johnson & Johnson, with several breakthrough drugs pulling weight while legacy products faltered. Merck reported $15.53 billion in total revenue, a 2% year-over-year decline, largely driven by a steep 62% drop in China sales. Its blockbuster immunotherapy Keytruda remains dominant, bringing in $7.21 billion (up 4%), nearly half of the company’s total revenue. A new subcutaneous formulation—which cuts injection time to just two minutes—is currently under U.S. and EU review. Meanwhile, Gardasil vaccine sales slid 41%, mostly due to China’s lingering stockpiles. Roche posted $17.24 billion in Q1 revenue, with pharma growing 8% to $13.34 billion. China was a highlight, showing double-digit growth. Biologics like Phesgo, Vabysmo, Xolair, and Hemlibra crossed the billion-dollar mark. The company also announced the start of a Phase III Alzheimer’s trial while axing three other pipeline projects. Sanofi’s revenue reached $10.46 billion, growing nearly 10%, led by strong U.S. performance (+15.4%). China revenues, however, slipped 1.7%. Its R&D spend was nearly $1.91 billion, funding major regulatory milestones in asthma, autoimmune, and neurodegenerative diseases, with seven pivotal trial updates expected in the second half of 2025. BMS faced a 6% decline, totaling $11.2 billion in Q1. However, its new portfolio outperformed: Opdivo, Breyanzi, and Camzyos led a 16% growth in newer therapies. The company is now forecasting up to $46.8 billion in 2025 revenue. CAR-T product Breyanzi and KRAS inhibitor Krazati were top growers, while legacy drugs like Abraxane and Revlimid fell sharply. Johnson & Johnson exceeded expectations with $21.9 billion in revenue (+2.4%). Strong gains from Darzalex, Carvykti, and Tremfya compensated for steep declines in Stelara (-34%) due to generic erosion. New combo therapies and oral biologic alternatives in late-stage development are expected to fuel momentum into 2026. From regulatory wins to strategic pipeline shifts, Big Pharma is moving fast to realign for post-patent growth. But China’s sluggish demand and trade-related tariffs will remain drag factors as the year unfolds.

VaccinePhase 3Financial Statement

100 Deals associated with Mavacamten

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External Link

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB14921

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertrophic obstructive cardiomyopathy	United States	Bristol Myers Squibb Co.	28 Apr 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	United States	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	China	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Japan	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Australia	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Austria	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Belgium	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Brazil	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Canada	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Czechia	Bristol Myers Squibb Co.	14 Dec 2022
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Denmark	Bristol Myers Squibb Co.	14 Dec 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05174416 (EXPLORER-CN, Pubmed \| Cardiol Ther)	Phase 3	Hypertrophic obstructive cardiomyopathy	81	Mavacamten	lnqftwwxnd(bzbmaiedec): P-Value = < 0.001 View more	Positive	29 Apr 2025
				Placebo
NCT05582395 (ODYSSEY-HCM, Company_Website) Manual	Phase 3	Hypertrophic Cardiomyopathy without Obstruction	580	Camzyos	hnlomhvpyf(xqwquodoie) = did not meet jmgtcrlgfm (ebossmlskf ) Not Met View more	Negative	14 Apr 2025
				Placebo
NCT04766892 (EMBARK-HFpEF, CTgov)	Phase 2	Heart failure with normal ejection fraction	30	Mavacamten	ywcrkzkani = xgtxvbdhzr uvrqzehjkx (blbsldsvwl, dybvqkwuyg - bwtfczhupe) View more	-	20 Mar 2025
NCT03496168 (PIONEER-OLE, CTgov)	Phase 2	Hypertrophic obstructive cardiomyopathy	13	Mavacamtem (Mavacamtem)	eosisicxgc = kyxvicwivx pqcwgjmxww (cimgpnqdsz, anbimvvqgc - thpgminxdb) View more	-	09 Jan 2025
				Mavacamten (Mavacamten)	xjvatqnkgh(xbvwkjrrji) = eqneqeyatg aamknqkppy (ysjwnmgdhr, feimuofnvi - ksnnfhphco) View more
NCT05414175 (HORIZON-HCM, CTgov)	Phase 3	Hypertrophic obstructive cardiomyopathy	38	Mavacamten	kppfvcwalb(bnckzpmukg) = txwfceioue vtlatsmciw (jawpkrxpwo, 31.55674) View more	-	04 Dec 2024
NCT03470545 (EXPLORER-HCM, Pubmed \| J Card Fail)	Phase 3	Hypertrophic obstructive cardiomyopathy	-	mavacamten (Age ≤60 years)	wjtcbicsyi(trdlimzexc) = ubelfobshn dnyqbdxndn (uyczfxwlre ) View more	Positive	01 Dec 2024
				mavacamten (Age >60 years)	wjtcbicsyi(trdlimzexc) = rgfvckofyi dnyqbdxndn (uyczfxwlre ) View more
NCT05174416 (EXPLORER-CN, CTgov)	Phase 3	Hypertrophic obstructive cardiomyopathy	81	Mavacamten (Mavacamten)	xzvljbausy(oudnblkpci) = cduwoeuwxn wpborwrkik (wayyyvvepa, 6.150) View more	-	19 Sep 2024
				Placebo (Placebo)	xzvljbausy(oudnblkpci) = pzdnivayxu wpborwrkik (wayyyvvepa, 8.535) View more
NCT03723655 (EXPLORER-LTE, BusinessWire) Manual	Phase 3	Hypertrophic obstructive cardiomyopathy	251	CAMZYOS® (mavacamten)	yppzyvuoga(ywzvwbyxui) = jvafxlzwuh pkocbvyvlq (klzqltoftn ) View more	Positive	01 Sep 2024
NCT04349072 (Pubmed \| JACC Cardiovasc Imaging)	Phase 3	Hypertrophic obstructive cardiomyopathy	-	Mavacamten	iahkiylell(xjumpblhml) = wldzgbmyte pexfiqmqvw (fxhgpaacsg ) View more	-	01 Sep 2024
				Placebo	iahkiylell(xjumpblhml) = gcpviaigya pexfiqmqvw (fxhgpaacsg ) View more
ESC2024	Not Applicable	Hypertrophic obstructive cardiomyopathy	-	Mavacamten 2.5 mg	msfievucqr(gdasiiqfye) = vcmocqwpdv tzqkfgadjx (rwmudgukgb ) View more	-	31 Aug 2024
				Mavacamten 5 mg	msfievucqr(gdasiiqfye) = lmqpencwdc tzqkfgadjx (rwmudgukgb ) View more