7 Cardiology Headlines You Missed in November 2025

November was a busy month for cardiology, between the US Food and Drug Administration’s (FDA) groundbreaking approval of plozasiran and the mountain of news presented at the American Heart Association’s Scientific Sessions 2025 in New Orleans, Louisiana. From olezarsen’s efficacy in severe hypertriglyceridemia to self-administered etripamil’s restoration of normal sinus rhythm in paroxysmal supraventricular tachycardia (PSVT), several major names in the cardiovascular pipeline made significant progress towards New Drug Application (NDA) submission last month.

The editorial team at HCPLive has collected 7 of the most impactful headlines from this past month to make catching up a bit easier. Check them out below.

FDA Decisions

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

Announced on November 18, 2025, Arrowhead Pharmaceuticals’ plozasiran received FDA approval for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome. The approval was based on the PALISADE phase 3 trial, which saw statistically significant reductions in apoC-III, triglycerides, and acute pancreatitis incidence. Plozasiran is now available for sale in the US.

Trial Results

STORM-PE: Computer-Assisted Vacuum Thrombectomy Outperforms Anticoagulation, With Robert Lookstein, MD

Patients with intermediate to high risk of pulmonary embolism saw much greater reduction in right-to-left-ventricular diameter ratio within 48 hours after receiving computer-assisted vacuum thrombectomy (CAVT), compared to those receiving anticoagulation therapy alone. The CAVT device has a significantly smaller and less rigid catheter, which is administered via a vacuum pump rather than an injection. Lookstein also discusses the comparatively short amount of time required for the operation, making it far more efficient than standard catheter devices or anticoagulation therapy in removing blood clots.

TRANQUILITY: Pacibekitug Safely Lowers hs-CRP in ASCVD, With Deepak Bhatt, MD

Pacibekitug, Tourmaline Bio’s investigational long-acting fully human monoclonal antibody against the IL-6 cytokine proved its safety and efficacy in lowering high-sensitivity C-reactive protein in patients with chronic kidney disease and atherosclerotic cardiovascular disease. Deepak Bhatt, MD, director of the Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai and lead presenter for TRANQUILITY at AHA 2025, expressed his hope for a phase 3 trial to examine cardiovascular endpoints with the drug.

OCEANIC-STROKE: Asundexian Achieves Primary Efficacy Endpoint in Patients with Ischemic Stroke

Asundexian, Bayer’s investigational, once-daily oral FXIa inhibitor, met its primary endpoints in the phase 3 OCEANIC-STROKE trial, reducing ischemic stroke risk without increasing major bleeding in patients after an acute ischemic stroke or transient ischemic attack. This November 23, 2025 announcement came on the heels of Johnson & Johnson and Bristol Myers Squibb cancelling their own investigative programs, testing another FXIa inhibitor milvexian for acute coronary syndrome.

Conference Coverage

Olezarsen Proves Efficacy in Severe Hypertriglyceridemia, With Nicholas Marston, MD

Presented at AHA 2025 by Nicholas Marston, MD, cardiologist and assistant professor of medicine at Brigham and Women’s Hospital, the phase 3 CORE and CORE2 trials both highlighted the efficacy of olezarsen in lowering fasting triglyceride levels in patients with severe hypertriglyceridemia. The investigative antisense oligonucleotide also reduced apoC-III, remnant cholesterol, and non-HDL-C to a greater degree compared to placebo across both studies.

Sotatercept Improves Composite Mortality Endpoint in Patients With PAH, With Vallerie McLaughlin, MD

Presented at AHA 2025 by Vallerie McLaughlin, MD, lead study author and Kim A. Eagle MD Endowed Professor of Cardiovascular Medicine at the University of Michigan Medical School, this composite analysis of the PULSAR, STELLAR, and ZENITH trials indicated sotatercept’s efficacy in reducing mortality and major morbidity outcomes in pulmonary arterial hypertension. The first-in-class novel fusion protein rebalances pulmonary vascular homeostasis by inhibiting ligands in the TGF-β superfamily.

Self-Administered Nasal Etripamil Restores Sinus Rhythm Safely, With James Ip, MD

Nasal etripamil spray, a fast-acting intranasal calcium-channel blocker, has been designed specifically for self-administration in patients with PSVT, ideally for use both in and outside of healthcare centers. This conversation with James Ip, MD, a professor and cardiologist at Weill Cornell Medicine and the lead presenter of these data at AHA 2025, covers the NODE-1, NODE-301 part 1 and 2, NODE-302, and NODE-303 phase 3 clinical trials investigating the agent’s efficacy in restoring sinus rhythm. The FDA is expected to release its decision on etripamil’s NDA on December 13, 2025.