First Half 2026 Recap - Cardiology

Although recent months have seen a substantial uptick in approvals, the first half of 2026 was a relatively quiet period for the US Food and Drug Administration (FDA). However, this dearth of regulatory updates was balanced out by a significant number of clinical trials reaching statistical significance in everything from heart failure to atherosclerotic cardiovascular disease (ASCVD), with major readouts presented at a slew of conferences across the country.

With so much data being revealed in the last 6 months, the editorial team at HCPLive has collected 9 of the most impactful headlines from this period to help you catch up on anything you may have missed:

FDA News

FDA Approves Olezarsen (Tryngolza) for Severe Hypertriglyceridemia

On June 24, 2026, 6 days ahead of its scheduled PDUFA date, the FDA announced its approval of olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adult patients with severe hypertriglyceridemia. This decision makes olezarsen the first therapy approved for this specific indication. The once-monthly, self-administered subcutaneous drug will be available in the US at some point in July, according to the announcement by parent company Ionis.

FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy

On May 18, 2026, the FDA approved baxdrostat as an add-on treatment for adults with hypertension inadequately controlled with other antihypertensive agents. Parent company AstraZeneca announced that the decision was based on positive data from the phase 3 BaxHTN trial, which showed substantially greater reductions in mean seated systolic blood pressure in patients treated with baxdrostat compared to placebo.

FDA Clears AI Program Powering Kardia 12L Electrogram for 5 New Cardiac Determinations

On January 13, 2026, parent company AliveCor announced that the FDA cleared the next generation of KAI 12L, the program powering the Kardia 12L Electrocardiogram System, for 5 additional determinations including 3 rhythm modifiers – short PR interval, atrial bigeminy, and ventricular bigeminy – and 2 axis-related morphology determinations – left axis deviation and right axis deviation. The clearance allows the smaller, more portable version of a standard 12-lead ECG machine to provide care to a wider group of patients.

Trial Data

ACACIA-HCM: Aficamten Beats Placebo in Non-Obstructive Hypertrophic Cardiomyopathy

Announced on May 5, 2026, by parent company Cytokinetics, aficamten significantly outperformed placebo among patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), based on topline data from ACACIA-HCM. The trial saw patients receiving aficamten display substantial improvements in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and maximal exercise performance compared to placebo recipients.

Asundexian Reduces Stroke Incidence Without Increasing Bleeding, With Ashkan Shoamanesh, MD

The OCEANIC-STROKE trial has displayed asundexian’s significant efficacy in reducing stroke risk among patients who have recently experienced non-cardioembolic stroke or a transient ischemic attack (TIA) without increasing bleeding. Topline results demonstrated that patients in the asundexian group exhibited significantly lower ischemic stroke incidence than the placebo group, with major bleeding incidence similar between both arms. This indicates asundexian’s revolutionary lack of bleeding increase among these patients.

CORALreef Lipids: Enlicitide Reduces LDL-C in Patients With ASCVD, With Ann Marie Navar, MD, PhD

The CORALreef Lipids trial has demonstrated enlicitide decanoate’s efficacy in reducing LDL-C levels compared to placebo in patients with or at risk of atherosclerotic cardiovascular disease (ASCVD) events. The oral macrocyclic peptide PCSK9 inhibitor was examined over a 52-week period, a substantial extension compared to prior trials of enlicitide for this indication.

Clinician Insights

HFmrEF as a Unique Phenotype of Heart Failure, With Jane Wilcox, MD, MSc

The Heart Failure Society of America released in May an official scientific statement recategorizing HFmrEF as an individual, unique phenotype of HF, distinct from HFpEF or HFrEF. The document suggests that clinicians view HFmrEF as all patients with HF and a left ventricular ejection fraction between 40% and 49%. Given the similarity of their structure and symptoms, clinicians agree that HFmrEF is a milder form of HFrEF and can be treated similarly.

Addressing the Limitations of Quadruple Therapy in HFrEF, With Stephen Greene, MD

Although clinical trials have shown promising results, quadruple therapies for HFrEF are not yet sufficient to reduce mortality and hospital readmission risks among older patients. Known as the four pillars of heart failure, ARNIs, beta-blockers, MRAs, and SGLT2 inhibitors are strongly recommended across all cases of heart failure. However, despite treatment with these medications, absolute risk of cardiovascular mortality remains largely unaffected.

Addressing Fenofibrates’ Lack of Cardiovascular Benefit, With Payal Kohli, MD, FACC

Despite substantially increasing evidence of their ineffectiveness and the FDA’s updating of their labeling information to reflect this, fenofibrates are still being prescribed to reduce cardiovascular risk at a significant volume. The editorial team at HCPLive spoke with Payal Kohli, MD, FACC, founder and medical director of Cherry Creek Heart and associate adjunct professor in the division of cardiology at Duke University School of Medicine, to discuss the need to phase out these ineffective and potentially dangerous medications.