Winrevair (sotatercept-csrk) / BMS, Merck (MSD) - LARVOL DELTA

Access to Winrevair expands with new public coverage in Canada (Pulmonary Hypertension News) - "Winrevair (sotatercept-csrk), an injection therapy approved for adults with pulmonary arterial hypertension (PAH), is now covered by several of Canada’s publicly funded health programs. The therapy’s developer Merck, known as MSD outside the U.S. and Canada, announced that Winrevair has been added to the public drug formularies of British Columbia, Non-Insured Health Benefits (NIHB), Nova Scotia, Quebec, and Veterans Affairs Canada (VAC)."

Reimbursement • Pulmonary Arterial Hypertension

Therapeutic potential of 20-Hydroxyecdysone in pulmonary arterial hypertension: involvement of Mas receptor and PI3K-Akt pathway. (PubMed, Cell Mol Biol Lett) - "20E inhibits PASMC proliferation and migration through Mas-dependent mechanisms and modulation of downstream PI3K-Akt signaling, thereby effectively preventing and rescuing PAH. It may be a promising pharmacological candidate for PAH treatment."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CDKN1A

Sotatercept improves right ventricular function but is associated with new or worsening pericardial effusions: a CMR study in intermediate-high risk PAH. (PubMed, J Cardiovasc Magn Reson) - "CMR tracks improvements in right heart chamber size, mass and function along with metrics of RV afterload in patients with PAH receiving sotatercept. The improvements in RV size and function met or exceeded the clinically relevant minimally important differences for these CMR-derived metrics in patients with PAH. Routine interval surveillance with CMR in patients receiving sotatercept will also enable surveillance for the off-target finding of new-onset or worsening pericardial effusions."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Marked clinical and haemodynamic improvement with sotatercept in severe refractory pulmonary arterial hypertension associated with corrected complex congenital heart disease. (PubMed, Respir Med Case Rep) - "Despite treatment with tadalafil, ambrisentan, and high dose subcutaneous treprostinil, she remained at intermediate-high risk, with WHO-FC III, NT-proBNP 3773 pg/mL and a 6-min walk distance (6MWD) of 480 m. Sotatercept was initiated through an expanded access program. A significant and rapid improvement in haemodynamics and functional capacity was observed after starting sotatercept, in a patient with severe PAH-CHD refractory to maximal therapy. Sotatercept may represent an effective rescue therapy and a potential therapeutic option for complex and severe PAH patients."

Journal • Cardiovascular • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Updates in the Treatment of Pediatric Pulmonary Arterial Hypertension. (PubMed, Cardiol Rev) - "Recent advances highlight differences in monotherapy versus combination pharmacological regimens, alongside active trials investigating interventional/surgical procedures in the amelioration of long-term outcomes. This review seeks to consolidate contemporary data and clinical trial highlights to reflect a necessary shift toward precise, developmentally informed pharmacotherapy in children, underscoring the pressing need for an updated pharmacological guideline that incorporates pediatric-specific trials and harmonizes labeling and long-term safety surveillance in the treatment of pediatric PAH."

Journal • Cardiovascular • Hypertension • Pediatrics • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Reverse Remodeling of the Pulmonary Vasculature: a Longitudinal, Investigational Study of the Effects of Sotatercept. (clinicaltrials.gov) - P=N/A | N=30 | Not yet recruiting | Sponsor: Franz Rischard, DO

New trial • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

612. Meet the Trialists III (ACC 2026) - "This After Chat session takes an in-depth look at trails from Late Breaking Clinical Trial sessions 105 and 107, specifically: DASH-patterned Groceries to Reduce Blood Pressure Among Adults With Treated Hypertension: Results From The GoFreshRx Randomized Clinical Trial Spironolactone In The Treatment Of Heart Failure Efficacy And Safety Of Sotatercept In Combined Post- And Pre-capillary Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction: Results From The Phase 2 Cadence Trial"

Late-breaking abstract • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Efficacy And Safety Of Sotatercept In Combined Post- And Pre-capillary Pulmonary Hypertension Associated With Heart Failure With Preserved Ejection Fraction: Results From The Phase 2 Cadence Trial (ACC 2026) - "Abstract is embargoed at this time."

Clinical • Late-breaking abstract • P2 data • Cardiovascular • Congestive Heart Failure • Heart Failure • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

TITLE: THE EFFECT OF SOTATERCEPT IN PATIENTS OF PULMONARY ARTERY HYPERTENSION: A SYSTEMATIC REVIEW AND META-ANALYSIS (ACC 2026) - "Sotatercept significantly improves pulmonary hemodynamics, exercise tolerance, and cardiac biomarker profiles in patients with PAH. These findings highlight its potential beyond conventional vasodilator therapy. However, further large scale clinical trials should be conducted."

Retrospective data • Review • Cardiovascular • Heart Failure • Hypertension • Pulmonary Arterial Hypertension

A TALE OF TWO OBSTRUCTIONS: CARDIAC TAMPONADE AFTER INITIATION OF SOTATERCEPT IN PULMONARY ARTERIAL HYPERTENSION (ACC 2026) - "Large volume pericardial effusion with tamponade and sustained high output after initial drainage may be observed with sotatercept, with an undefined risk of recurrence. In PAH patients who show clinical improvement on sotatercept but develop cardiac tamponade, pericardial window may be an option to enable the safe continuation of therapy."

Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

IMPACT OF SOTATERCEPT ON FUNCTIONAL AND HEMODYNAMIC OUTCOMES IN PULMONARY ARTERIAL HYPERTENSION- A SYSTEMATIC REVIEW AND META-ANALYSIS (ACC 2026) - "Sotatercept improved hemodynamic and functional outcomes in PAH, with a higher risk for elevated hematocrit. These findings support sotatercept as a promising therapy in PAH. More randomized trials are needed to confirm these observations."

Retrospective data • Review • Cardiovascular • Hematological Disorders • Hypertension • Pulmonary Arterial Hypertension • Respiratory Diseases • Thrombocytopenia • TGFB1

OFF-LABEL SOTATERCEPT IN HIGH-RISK PULMONARY HYPERTENSION WITH LIVER DISEASE AND LIMITED THERAPEUTIC OPTIONS (ACC 2026) - "Background: Pulmonary arterial hypertension (PAH) and its portopulmonary variant (PoPH) are progressive disorders with high morbidity and limited treatment options, especially in advanced liver disease Case: A 60-year-old woman with severe precapillary PAH from PoPH and COPD overlap (WHO Group 1 & 3), complicated by alcoholic cirrhosis (Child-Pugh A→B) and chronic thrombocytopenia (platelets 70K), remained high risk (REVEAL 2.0 > 9) despite tadalafil, macitentan, and selexipag.She presented with dyspnea and severe precapillary PAH unresponsive to maximal oral therapy; baseline hemodynamics showed markedly elevated pulmonary pressures. Sotatercept delivered meaningful benefit without safety events in advanced PoPH/PAH with cirrhosis and limited options, supporting its potential as an adjunct in complex high-risk PAH and as a bridge optimization pre-transplant"

Cardiovascular • Chronic Obstructive Pulmonary Disease • Fibrosis • Hematological Disorders • Hepatology • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Thrombocytopenia

THROMBOCYTOPENIA ASSOCIATED THYROID HEMATOMA FOLLOWING WINREVAIR THERAPY (ACC 2026) - "Background: Winrevair (sotatercept-cskr), approved in 2024 for pulmonary arterial hypertension (PAH, WHO Group 1), is an activin signaling inhibitor that enhances exercise capacity and slows disease progression...Case: A 41-year-old patient with PAH, previously treated with treprostinil, riociguat, and macitentan, started Winrevair... This case underscores the risk of severe thrombocytopenia with Winrevair, leading to a thyroid hematoma post-biopsy. Vigilant platelet monitoring, stricter pre-procedure thresholds, and dose adjustments are critical to prevent complications in PAH patients."

Cardiovascular • Endocrine Disorders • Hematological Disorders • Pulmonary Arterial Hypertension • Respiratory Diseases • Thrombocytopenia

Protocol for an open-label, randomised, controlled trial to evaluate the efficacy and safety of sotatercept add-on therapy compared with pulmonary vasodilator-based standard of care for pulmonary vasodilator-resistant pulmonary arterial hypertension associated with unrepaired congenital shunts (atrial septal defect, ventricular septal defect or patent ductus arteriosus), including Eisenmenger... (PubMed, BMJ Open) - P4 | "1071250069; ClinicalTrials.gov NCT07356778. Protocol version and date: V.1.3; 23 October 2025."

Clinical protocol • Journal • Cardiovascular • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Transplantation

Sotatercept in Patients With Eisenmenger Syndrome. (PubMed, Pulm Circ) - "We present two cases of patients with Eisenmenger syndrome treated with sotatercept. Sotatercept improved the subjective and objective exercise capacity in both patients without any significant adverse side effects."

Journal • Cardiovascular • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Pulmonary Hypertension Associated With Left Heart Disease: Challenges, Emerging Strategies, and Future Directions. (PubMed, J Am Coll Cardiol) - "Multiple pharmacologic agents, such as sotatercept, relaxin analogues, and levosimendan, along with device-based strategies such as pulmonary artery denervation, transcatheter atrial shunts, and pericardiotomy, are under investigation. Progress in clinical trials has been hindered by patient recruitment, phenotypic heterogeneity, and a lack of standardized functional and hemodynamic outcomes. This review summarizes the current knowledge on PH-LHD, highlights emerging pharmacologic and invasive therapies, discusses barriers to trial design and regulatory approval, and proposes a framework to guide future investigations."

Journal • Review • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Sotatercept for Right Ventricular Failure Following Heart Transplantation in a Patient with Elevated Pulmonary Vascular Resistance: A Case Report (ISHLT 2026) - "She was subsequently started on macitentan 10 mg daily and tadalafil 40 mg daily, resulting in symptomatic improvement and reduction of PVR to 2 WU...Initiation of sildenafil had minimal hemodynamic effect and was compounded by worsening peripheral vasodilation; Macitentan was also resumed...The therapy was well-tolerated and led to clinical and hemodynamic improvement. Future studies need to be conducted to understand the role Sotatercept may represent as a promising option in managing pulmonary vascular disease in the post-transplant setting."

Case report • Clinical • Cardiomyopathy • Cardiovascular • Infectious Disease • Nephrology • Pulmonary Arterial Hypertension • Renal Disease • Respiratory Diseases • Transplantation

Sotatercept Versus Selexipag in Severe Pulmonary Arterial Hypertension: An Indirect Comparison of Efficacy Based on an Artificial-Intelligence Method That Reconstructed Patient-Level Data From Three Randomized Trials. (PubMed, Cureus) - "AI-based reconstruction of individual patient data made it possible to compare the efficacy of therapies in the absence of direct head-to-head evidence. These findings suggest that sotatercept may reduce PAH-related events more effectively than selexipag, although the inference is derived from reconstructed and indirectly compared data."

Journal • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Sotatercept for Decompensated Pulmonary Arterial Hypertension Requiring VA ECMO: First Canadian ICU Experience. (PubMed, Pulm Circ) - "However, descriptions of its use to treat acute RV failure in an intensive care unit (ICU) setting are limited. We report a case of cardiogenic shock and respiratory failure secondary to decompensated PAH requiring veno-arterial extracorporeal membrane oxygenation (VA ECMO), with rapid improvement following sotatercept initiation."

Journal • Cardiovascular • Congestive Heart Failure • Critical care • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • Transplantation

SOTERIA: A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038) (clinicaltrials.gov) - P3 | N=815 | Recruiting | Sponsor: Merck Sharp & Dohme LLC

Trial initiation date • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

BMPR2 Splice-Site Variant in a Patient With Pulmonary Arteriovenous Malformation and Delayed-Onset Pulmonary Arterial Hypertension: A Case Report and Mechanistic Phenocopy Hypothesis. (PubMed, Am J Med Genet A) - "We also discuss the implications of sotatercept, a transforming growth factor-beta (TGF-β) superfamily ligand trap, which in this case was associated with symptomatic improvement and stable shunt burden. These findings contribute to the emerging recognition of atypical vascular phenotypes in BMPR2 variant carriers, particularly those presenting with PAVMs in the absence of HHT. It highlights the importance of considering genetic testing in isolated AVM presentations, as well as the need for longitudinal surveillance and mechanistic investigation into overlapping TGF-β/BMP signaling disorders."

Journal • Cardiovascular • CNS Disorders • Hematological Disorders • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • ACVRL1 • ALK1 • SMAD4 • TGFB1

Paradigm shift: from pulmonary vasodilation to cardiopulmonary dual-track therapy-a comprehensive review of pathophysiology and advances in pulmonary hypertension-associated right heart failure. (PubMed, Respir Res) - No abstract available

Journal • Review • Cardiovascular • Congestive Heart Failure • Heart Failure • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

MODELING THE IMPACT OF SOTATERCEPT ON MORBIDITY AND MORTALITY IN PULMONARY ARTERIAL HYPERTENSION: A MEXICAN POPULATION HEALTH PERSPECTIVE (ISPOR 2026) - "This model suggests that adding sotatercept to BGT could significantly improve life expectancy and reduce the need for hospitalizations and transplants in Mexican PAH patients."

Clinical • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

Do the Bubbles Signal Trouble? Sotatercept Use in a Patient With Liver Disease (ATS 2026) - No abstract available

Clinical • Hepatology

Improvement of size, shape but not RV function with sotatercept in pulmonary arterial hypertension: insights from a french nationwide real-world echocardiographic study (HEART FAILURE 2026) - No abstract available

Clinical • Real-world • Real-world evidence • Cardiovascular