Q4 2025 Recap: Cardiology News and Updates

The final quarter of 2025 saw an avalanche of critical trial results and US Food and Drug Administration (FDA) approvals. From hypertension and heart failure to lipid management and cardiomyopathy, the FDA brought about substantial progress across the scope of cardiology during the last 3 months.

Trial data from SELECT, ATTRibute-CM, and other key studies were also released during this quarter, with drugs like olezarsen and baxdrostat advancing rapidly through the pipeline while semaglutide achieved a groundbreaking new indication in cardiovascular care.

The editorial team at HCPLive has collected 10 of the most impactful headlines from Q4 of 2025 – check them out below:

FDA News

FDA Approves Updated Indication for Sotatercept-csrk (WINREVAIR) in Adult PAH

On October 27, 2025, the FDA approved an updated indication for sotatercept-csrk, allowing for its use in treating pulmonary arterial hypertension (PAH) in adult patients. While sotatercept was previously approved to improve exercise capacity and WHO functional class, data from the phase 3 ZENITH study highlighted its capacity to reduce risk of composite death from any cause, lung transplantation, or hospitalization for worsening PAH.

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

On November 18, 2025, Arrowhead Pharmaceuticals announced the FDA’s approval of plozasiran for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome (FCS). The first-in-class RNA interference therapeutic displayed its efficacy in the PALISADE phase 3 trial, where it outperformed placebo in reducing triglycerides and acute pancreatitis risk. Plozasiran also exhibited a favorable tolerability profile throughout the trial.

FDA Approves Etripamil (Cardamyst) Nasal Spray for PSVT

On December 12, 2025, the FDA approved etripamil nasal spray for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm. This is the first fast-acting, self-administered treatment for PSVT, which is predicted to substantially lower the number of hospitalizations or emergency department visits for abnormal sinus rhythms. The FDA’s decision was based on a wide range of trials, a collective analysis of which revealed a significantly greater percentage of patients achieved normal sinus rhythm with etripamil compared to placebo.

FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

Lerodalcibep-liga received its FDA approval on December 15, 2025, as a result of positive data from the LIBerate program. This was a series of 5 global phase 3 registration studies which highlighted the small protein-binding third-generation PSCK9 inhibitor’s capacity for LDL-C lowering in patients with hypercholesterolemia. Most recently, the LIBerate-HoFH phase 3 trial indicated lerodalcibep’s noninferiority to evolocumab, with a 9.1% average decrease in LDL-C from lerodalcibep and a 10.8% average decrease in evolocumab.

FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy

Aficamten received FDA approval for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) on December 19, 2025, based on data from the phase 3 SEQUOIA-HCM trial. During this study, patients taking aficamten demonstrated superior exercise capacity improvements compared to those on placebo, as well as increased peak oxygen uptake. Aficamten was also well tolerated, with no instances of worsening heart failure or treatment interruptions due to LVEF.

Trial Results

Bax24: Baxdrostat Achieves Primary Endpoint in Treatment-Resistant Hypertension

The Bax24 phase 3 trial saw baxdrostat, a first-in-class, highly potent and selective oral small molecule designed by AstraZeneca to inhibit aldosterone synthase, achieve its primary endpoint of a statistically significant reduction in ambulatory 24-hour average systolic blood pressure (SBP) in patients with treatment-resistant hypertension (rHTN). The randomized, double-blind, placebo-controlled, parallel group study compared baxdrostat to placebo in 218 patients over 12 weeks.

SELECT: Semaglutide Indicates Possible Cardiovascular Disease-Modifying Effect

The SELECT phase 3 trial saw semaglutide outperform placebo in reducing the risk of major adverse cardiovascular events in patients with established atherosclerotic cardiovascular disease (ASCVD) and overweight or obesity, but without diabetes. This cardioprotective effect would go on to provide evidence for the later FDA approval of oral semaglutide for a cardiovascular indication, marking the first oral GLP-1 to cross over into cardiology.

ATTRibute-CM: Acoramidis Reduces Cardiovascular Mortality and Hospitalization, With Ahmad Masri, MD

The phase 3 ATTRibute-CM trial saw acoramidis substantially reduce cumulative cardiovascular mortality and recurrent cardiovascular-related hospitalization over 30 months in patients with transthyretin amyloid cardiomyopathy (ATTR-CM). These data were presented at the Heart Failure Society of America Scientific Meeting by Ahmad Masri, MD, director of the Hypertrophic Cardiomyopathy Center at Oregon Health & Science University.

CORE/CORE2: Olezarsen Achieves Primary Endpoint in Severe Hypertriglyceridemia

During the CORE and CORE2 phase 3 trials, investigative antisense oligonucleotide olezarsen achieved its primary endpoint of a highly significant mean reduction in fasting triglyceride levels in patients with severe hypertriglyceridemia. This result was sustained through the full 12-month duration, indicating olezarsen’s superiority to placebo.

CeleBrate: Zalunfiban Administration at First Contact Improves STEMI Outcomes, With C. Michael Gibson, MD

During the CeleBrate trial, subcutaneous glycoprotein IIb/IIIa inhibitor zalunfiban successfully achieved its primary efficacy endpoint, a hierarchical proportional odds model ranking all-cause death, stroke, recurrent myocardial infarction, acute stent thrombosis, new-onset or re-hospitalization for heart failure, larger infarct size, or no endpoint through 30 days. Should this lead to an FDA approval in the future, zalunfiban could revolutionize treatment for patients with suspected ST-segment elevation myocardial infarction.