Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

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.

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


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 

. 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.


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

Patients with intermediate to high risk of 

 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 

. 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 

 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.


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 

. 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.

Articles

November saw significant advancements in cardiology, highlighted by the FDA's approval of plozasiran for familial chylomicronemia syndrome and notable findings from the American Heart Association's Scientific Sessions 2025. Key developments included the efficacy of olezarsen in severe hypertriglyceridemia, the success of self-administered nasal etripamil in restoring sinus rhythm in PSVT, and promising trial results for pacibekitug, asundexian, and sotatercept. These advancements underscore the progress in cardiovascular therapeutics, with several drugs moving closer to New Drug Application submissions.

Catch up with major FDA decisions, critical conference news, and more.

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7 Cardiology Headlines You Missed in November 2025

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

Overview of the ADVANCE trials showing ICO’s superior efficacy to deucravacitinib and consistent safety across 24 weeks.

The Psychosocial Impact of Psoriasis in Pediatric Patients: Why Treating Aggressively Early Matters 

, despite the expanding therapeutic landscape. Linda Stein Gold, MD, and her colleagues analyze patient- and provider-reported data from the 

 surveys, revealing that many patients remain dissatisfied with current therapies and that oral agents are overwhelmingly preferred over injectables. The experts discuss how patient lifestyle, comorbidities, and psychosocial burden influence shared decision-making and treatment adherence. They also interpret the 

International Psoriasis Council’s (IPC)

 and explore its implications for reducing “topical churn” and advancing systemic therapy earlier in the disease course.

 and its potential to close current gaps in care. The panel provides an in-depth review of the 

 clinical development program, summarizing the 

 trials, which demonstrated superior efficacy versus deucravacitinib at both 16 and 24 weeks, with favorable safety and tolerability. They also discuss new 

 showing sustained clearance and no new safety signals in adults and adolescents. The faculty reflect on ICO’s implications for adolescent psoriasis and how early, aggressive oral intervention may help prevent progression to psoriatic arthritis, marking a significant milestone in the evolution of oral IL-23–targeted therapy.

The final portion of the series shifts focus to 

managing active psoriatic arthritis (PsA)

. The experts discuss new findings from the 

 demonstrated the first clear evidence of IL-23–mediated inhibition of structural joint damage, reinforcing the rationale for early biologic use in high-risk patients. They compare APEX to prior IL-23 studies, discuss implications for therapy sequencing, and highlight other emerging data from 

 studies. In closing, Stein Gold and colleagues emphasize a forward-looking approach that integrates personalized therapy selection, early detection of PsA, and cross-specialty collaboration to elevate standards of psoriasis care

Videos

Video Series

Remibrutinib Onset of Action and Safety Profile

New data on remibrutinib demonstrates the agent’s rapid onset of action in patients with chronic spontaneous urticaria (CSU). Shyam Joshi, MD, assistant professor of medicine in the Section of Allergy and Clinical Immunology at Oregon Health & Science University (OHSU) School of Medicine, discussesdiscusses data from phase 3 REMIX trials revealed that significant improvements in symptom control were observed as early as one to two weeks following initiation of therapy. This early efficacy distinguishes remibrutinib from established biologic therapies, such as omalizumab and dupilumab, which typically require longer durations to achieve comparable clinical endpoints.

The rapid mitigation of pruritus and hive activity provides clinically meaningful relief for patients who often experience prolonged morbidity prior to effective management. Early symptom resolution can improve sleep quality, daily functioning, and overall quality of life for individuals with CSU. For clinicians, the potential to offer immediate improvement is a significant advancement, particularly for those patients suffering with delayed diagnosis and limited success on previous therapies.

The most notable side effect in clinical trials was the occurrence of mild petechiae, which generally resolved without intervention and did not necessitate discontinuation of therapy. Importantly, incidence rates for infection, changes in immunoglobulin levels, and alterations in B cell function were comparable between remibrutinib and placebo groups. These data provide clinicians with confidence in prescribing remibrutinib as a safe and efficacious option within the CSU treatment landscape.

Shyam Joshi, MD, discusses the rapid onset of action and favorable safety profile of remibrutinib, distinguishing it among therapies for CSU.

 Remibrutinib Onset of Action and Safety Profile

Jennifer Soung, MD, outlines ICO’s mechanism as an IL-23 receptor antagonist and its significance in oral systemic therapy.

A Novel Treatment in Psoriasis: Expert Perspectives on the ICONIC-LEAD Trial

Matthew Dapas, PhD, research assistant professor at Northwestern University Feinberg School of Medicine

Polygenic Risk Scores Linked to Specific SLE Manifestations, With Matthew Dapas, PhD

, Matthew Dapas, PhD, of Northwestern University, discussed recent findings on polygenic risk scores for 

American College of Rheumatology Convergence (ACR) 2025

. The study evaluated associations between genetic risk and clinical features derived from electronic health records across more than 32,000 participants in the Electronic Medical Records and Genomics Network.

One advantage of this study was the large database. The polygenic risk score was derived using summary statistics from a genome-wide association study of 6748 lupus cases and 11,516 controls of European ancestry.

“The reality of the genetics of these diseases is that it's not one gene that causes a disease, but it's actually a constellation of very small effects that just are enough to tip the scales in one direction or the other,” Dapas told 

. “So, to identify those really small effects, you need really large databases. There's a number of large efforts, and [in] the United States… where we're trying to generate whole genome sequencing for millions of individuals to derive new discoveries and genetics because the more the more people you have in a database, the more accurate model you can build, more effective the implementation of that model will be in a clinical setting, and the better outcomes that leads.”

In the Northwestern cohort (n = 1061), the polygenic risk score predicted SLE with an area under the receiver operating characteristic curve of 0.724 and was significantly associated with both localized and systemic lupus (

= 1.6×10^-9) and systemic lupus erythematosus (

 = 3.0×10^-9). Additional nominal associations were observed for cardiac complications (

 = 2.8×10^-3) and impaired renal function (

 = 4.6×10^-3), with enrichment for circulatory system (

 = 9.7×10^-5) and hematopoietic traits (

Genetic risk was further associated with several individual Systemic Lupus International Collaborating Clinics criteria, including acute cutaneous lupus, thrombocytopenia, leukopenia, and low complement levels. Low complement was observed in 55% of patients in the highest polygenic risk score decile, compared with 30% in the lowest decile, suggesting that greater genetic risk may be linked to specific immunological features.

Dapas emphasized that although polygenic risk scores are not yet part of routine clinical practice, they have the potential to support risk assessment. Dapas noted that high-quality clinical data and patient evaluation, combined with expanding genomic databases, can help train risk models.

“I anticipate that's something that will become routine in the not-too-distant future,” he said. “One important thing to keep in mind, as a medical geneticist, [is that] we rely so much on that fundamental interaction between clinician and patient.”

He said this helps us train genetic risk models, which rely on accurate phenotyping and accurate classification

“Logging of data into a database that is then used for research is so essential, because without accurate workups of patients, it all kind of falls apart,” Dapas said. “In all my work, I work closely with a team of clinicians, and it really is kind of a symbiotic relationship. It's a whole network of individuals with different sets of expertise, working together to try and improve outcomes for patients with the disease. I appreciate what the clinicians do, and I hope, through this work and other geneticists, that we can collectively move the needle on some of these diseases.”

Dapas has no relevant reported disclosures.

Forrest N, Tuteja S, Pacheco J, Mitrovic V, Ramsey-Goldman R, Walunas T, Dapas M. Polygenic risk of lupus is differentially associated with individual EHR-derived classification criteria [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). 

https://acrabstracts.org/abstract/polygenic-risk-of-lupus-is-differentially-associated-with-individual-ehr-derived-classification-criteria/

Dapas M. Polygenic Risk Scores Reveal Genetic Drivers of Lupus Heterogeneity, With Matthew Dapas, PhD. HCPLive. November 24, 2025. https://www.hcplive.com/view/polygenic-risk-scores-reveal-genetic-drivers-lupus-heterogeneity-matthew-dapas-phd. Accessed December 3, 2025. 

ACR 2025 research shows polygenic risk scores correlate with specific SLE phenotypes, highlighting potential applications for clinical risk assessment.

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Rheumatology

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Amanda Armstrong, MD, MPH, predicts a move toward mechanism-based therapy selection and highlights biomarkers that could guide personalized treatment.

Personalizing CSU Management and the Role of Multidisciplinary Care

A conclusion emphasizing the importance of translating clinical research into everyday practice and continuing innovation to improve patient quality of life and long-term outcomes.

Combination Therapies for IBD and Future Outlook

Non-Cranial Symptoms in GCA

Jason Hawkes, MD, MS examines how adherence, patient expectations, and access barriers influence management and treatment sequencing in CSU.


Impact of Adherence on CSU Management

Forward-looking perspectives on how predictive biomarkers, genetic profiling, and precision tools will guide individualized IBD management in the coming years.

Role of IL-12/IL-23 Inhibitors in the Treatment Landscape of IBD

Discussion on factors such as comorbidities, adherence, and access that influence the choice between oral BTK inhibitors and injectable biologics.

Defining the Role of BTKi in CSU Treatment Algorithms

Current Gaps in Diagnostic Criteria Standards: Key Factors That Inform Diagnostic Decisions 

Hanania explains how IL-33 inhibitors including itepekimab and astegolimab may uniquely benefit COPD exacerbation.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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Prospecting the IL-33 Pathway for COPD Care, with Nicola Hanania, MD, MS

Gibson discusses the promising improvements to the composite primary endpoint of mortality, stroke, and recurrent MI as a result of zalunfiban treatment.

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

Hersh Shroff, MD, MPA, is a transplant hepatologist and an assistant professor of medicine at the University of North Carolina School of Medicine

Recent advancements in hepatology highlight new medications for metabolic dysfunction and liver diseases, promising improved patient outcomes and treatment options.

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Latest News

7 Cardiology Headlines You Missed in November 2025

The Psychosocial Impact of Psoriasis in Pediatric Patients: Why Treating Aggressively Early Matters

Remibrutinib Onset of Action and Safety Profile

A Novel Treatment in Psoriasis: Expert Perspectives on the ICONIC-LEAD Trial

Polygenic Risk Scores Linked to Specific SLE Manifestations, With Matthew Dapas, PhD