Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

 has become standard of care in pulmonary medicine, with approved agents across four mechanistic classes — anti-IgE (omalizumab), anti-IL-4/IL-13 (dupilumab), anti-IL-5 and anti-IL-5 receptor (mepolizumab, benralizumab, reslizumab, and depemokimab), and anti-thymic stromal lymphopoietin (tezepelumab) — supporting reductions in annualized exacerbation rates of 50% to 60% in appropriately selected patients.¹ 

The December 2025 FDA approval of depemokimab (Exdensur; GSK), a long-acting anti-IL-5 monoclonal antibody, introduced the first twice-yearly dosing interval in the class: SWIFT-1 and SWIFT-2 demonstrated 58% and 48% reductions, respectively, in annualized severe exacerbations versus placebo in patients aged 12 years and older with eosinophilic phenotype asthma.² Dupilumab's approved indication has also expanded into eosinophilic chronic obstructive pulmonary disease (COPD), with BOREAS and NOTUS demonstrating 30% and 34% reductions in moderate-to-severe exacerbations, respectively, alongside significant pre-bronchodilator FEV₁ improvements of approximately 83 mL over placebo at week 12 in patients with blood eosinophil counts of 300 cells/µL or greater on maximal triple therapy.³,⁴ These advances have broadened the biologic-eligible population substantially; yet prescribing rates remain far below the scale of the eligible burden, with access barriers, insurance restrictions, and Medicare cost constraints cited as primary drivers of the gap between evidence and clinical practice.

 convened a panel of advanced practice providers — nurse practitioners and physician assistants — representing pulmonary practices across Oklahoma for an in-depth discussion of real-world biologic prescribing in asthma and COPD. The forum was moderated by Samantha Bellinger, APRN, a pulmonary nurse practitioner with 11 years of experience at Integris Baptist Pulmonary Medicine in Oklahoma City, and included peers from Mercy Pulmonology, Breathe Oklahoma, Variety Care, and rural eastern Oklahoma practices. The panel's geographic and practice diversity — spanning urban academic-affiliated pulmonology, Cherokee Nation–served rural practices, private practice, and federally qualified health centers — provided an unusually granular view of how biologic therapy is integrated in communities where FeNO testing is frequently unavailable, oral corticosteroid overprescribing in primary care remains common, and formulary restrictions frequently determine agent selection as much as pharmacology does.

How GOLD 2025 and Mucus Plug Data Are Reshaping Biologic Selection in Eosinophilic COPD

The discussion was timely for several reasons. Updated GOLD 2025 guidelines formally incorporated biologic therapy into COPD escalation pathways, recommending dupilumab for patients with persistent exacerbations and blood eosinophil counts of 300 cells/µL or greater on maximal triple therapy — a change panelists described as directionally consistent with how many had already been prescribing, though the formal endorsement lends institutional support in peer persuasion.⁵ Simultaneously, the VESTIGE and CASCADE trials demonstrated mucus plug score reductions with dupilumab and tezepelumab, respectively, versus placebo — findings that several panelists have translated into clinical practice by preferring IL-4/IL-13–targeting agents over IL-5s in patients with a chronic bronchitis or mucus-predominant phenotype.⁶

⁷ A novel, geographically specific concern emerged during the discussion: alpha-gal syndrome — a tick-transmitted sensitization to galactose-alpha-1,3-galactose with high prevalence in eastern Oklahoma — has not been evaluated in the context of biologic therapy, despite the fact that all current biologics are manufactured on Chinese hamster ovary cells that theoretically carry alpha-gal epitopes. Victoria Pierce, NP, whose practice serves the Cherokee Nation, reported empirically prescribing biologics in alpha-gal–sensitized patients with close monitoring and no observed reactions to date — a practice without any published guidance.

Insurance Coverage, Formulary Access, and Real-World Dupilumab Safety

Across the forum, panelists described a clinical environment in which biologic selection is driven at least as much by formulary access and insurance coverage as by pharmacologic reasoning. Dupilumab was the most frequently initiated agent across practices, valued for its broad indication, steroid-dependent indication, and comparative ease of approval in most commercial plans, though Blue Cross Federal was identified as a consistent denier. Pierce described mepolizumab as her most prescribed agent for the Cherokee Nation patient population due to its unrestricted formulary status — no prior authorization required — for approximately half her practice. Tezepelumab was positioned by the moderator as a functional Medicare substitute for dupilumab, given its ability to be administered at an infusion center for patients unable to use manufacturer copay assistance programs. Benralizumab was preferred for hypereosinophilic patients given its complete eosinophil depletion mechanism via apoptosis — considered particularly relevant in a patient population in which eosinophil counts in the thousands were described as disproportionately common — but faced inconsistent prior authorization outcomes in some rural areas. 

Several real-world safety observations emerged that are infrequently highlighted in trial data: eyelid inflammation leading to dupilumab discontinuation in at least 2 patients in one practice; arthralgias significant enough to prompt cessation in a patient with coexisting rheumatologic disease; and concern raised by Burgess, drawing on inpatient clinical experience, about second-exposure anaphylactic or angioedematous presentations in patients re-initiated on dupilumab. As Pierce noted during the discussion: "With those really high eosinophils, I really like to go straight to Fasenra because of the apoptosis. It just completely depletes it all. I really like that. And then the dosing is convenient, but it's really hard for me to get approved in my area for whatever reason."

Depemokimab generated genuine interest but no enthusiastic first adopters among the panel. The key concern was not efficacy but risk management: with a 6-month pharmacologic duration that extends beyond the labeled dosing interval, a patient with an inadequate response or emerging adverse effect at 3 months cannot be re-dosed, switched to another agent, or have the drug effectively removed. The ideal candidate described by multiple panelists was an adherence-challenged patient — specifically, a college student who could receive reliably administered doses during clinic visits twice per year — rather than a biologic-naive patient in whom response is not yet established. 

The COPD biologic discussion was framed largely around preventing fatal exacerbations rather than restoring spirometry, with panelists consistently pushing back against colleague skepticism anchored to FEV₁ alone. One panelist described a patient with a baseline FEV₁ of 21% and dependence on supplemental oxygen who achieved oxygen independence on dupilumab and subsequently traveled by motorcycle — a case that has since informed her broader approach to COPD biologic prescribing. Panelists identified pulmonary rehabilitation access, practical smoking cessation infrastructure beyond the "stop smoking" recommendation, and a neutrophil-targeting agent that does not compromise infection defense as the most meaningful unmet needs in their predominantly rural, underserved patient populations.³

Global Initiative for Asthma. Global Strategy for Asthma Management and Prevention. Updated 2025. Accessed June 2026. https://ginasthma.org

Jackson DJ, Wechsler ME, Menzies-Gow A, et al; SWIFT-1 and SWIFT-2 Investigators. Twice-yearly depemokimab in severe asthma with an eosinophilic phenotype. 

 2024;391(24):2337–2349. doi:10.1056/NEJMoa2406673

Bhatt SP, Rabe KF, Hanania NA, et al; BOREAS Investigators. Dupilumab for COPD with type 2 inflammation indicated by eosinophil counts. 

 2023;389(3):205–214. doi:10.1056/NEJMoa2303951

Bhatt SP, Rabe KF, Hanania NA, et al; NOTUS Study Investigators. Dupilumab for COPD with blood eosinophil evidence of type 2 inflammation. 

 2024;390(24):2274–2283. doi:10.1056/NEJMoa2401304

Global Initiative for Chronic Obstructive Lung Disease. GOLD 2025 Report: Global Strategy for the Diagnosis, Management, and Prevention of COPD. Updated 2025. Accessed June 2026. https://goldcopd.org

Maspero J, Laidlaw TM, Onoue M, et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. 

Nordenmark LH, Hellqvist Å, Emson C, et al. Tezepelumab and mucus plugs in patients with moderate-to-severe asthma. 

 2023;2(10):EVIDoa2300135. doi:10.1056/EVIDoa2300135

Articles

Biologics across anti-IgE, IL-4/IL-13, IL-5/IL-5R, and TSLP pathways are entrenched in severe asthma, and newer evidence is expanding type 2–targeted therapy into eosinophilic COPD. Depemokimab offers first twice-yearly anti–IL-5 dosing, while dupilumab shows exacerbation and modest FEV₁ benefits in eosinophilic COPD and is now embedded in GOLD 2025. In Oklahoma practices, agent choice is heavily payer-driven, safety signals shape monitoring, and alpha-gal sensitization remains an unstudied yet practical consideration. Mucus-plug data are steering some clinicians toward IL-4/IL-13 or TSLP blockade in bronchitis phenotypes, but access and cost barriers sustain underutilization.

Oklahoma APPs share real-world asthma and COPD biologic wins, safety surprises, and insurance hurdles as new twice-yearly options emerge.

News

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COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

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.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Biologic Therapy for Asthma and COPD: Real-World Perspectives From APPs

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.

On July 9, 2026, AstraZeneca and Ionis reported that the phase 3 CARDIO-TTRansform trial of eplontersen (Wainua) did not meet its primary efficacy endpoint in adults with 

transthyretin-mediated amyloid cardiomyopathy (ATTR-CM)

“The CARDIO-TTRansform trial was designed to examine the role of Wainua, a gene silencer treatment, on top of today’s standard of care in reducing recurring cardiovascular events and mortality,” Sharon Barr, executive vice president of BioPharmaceuticals R&D, said in a statement. “Although the trial did not meet its primary objective, we believe the results support greater scientific understanding of treatment approaches for the hundreds of thousands of patients worldwide suffering from this progressive and often fatal condition.”

CARDIO-TTRansform Missed Primary ATTR-CM Endpoint

In the overall study population, adding eplontersen to contemporary standard of care did not produce a statistically significant benefit on the composite of cardiovascular mortality and recurrent cardiovascular events compared with placebo, the companies reported. The trial included substantial use of transthyretin stabilizer therapy, with 57% of patients in each arm receiving a stabilizer at baseline and an additional 24% in each arm initiating a stabilizer during the trial.

Among patients treated with eplontersen monotherapy vs placebo, fewer primary composite events were observed, and the result was nominally significant, according to the companies. In patients receiving stabilizer therapy at baseline, no treatment effect was observed.

ATTR-CM can be hereditary or wild-type and is characterized by cardiac deposition of amyloid fibrils composed of misfolded transthyretin protein. The condition can present with nonspecific signs and symptoms, including dyspnea, edema, palpitations, dizziness, weakness, and fatigue. The companies cited an estimated 300,000 to 500,000 people living with ATTR-CM worldwide, while noting the condition remains underrecognized as a cause of heart failure.

Eplontersen Trial Design and Reported Safety

CARDIO-TTRansform was a global, multicenter, randomized, double-blind, placebo-controlled phase 3 trial evaluating eplontersen in adults with wild-type or hereditary ATTR-CM receiving available standard of care. The trial enrolled 1432 participants across 130 sites in 20 countries. Participants were randomly assigned in a 1:1 ratio to receive eplontersen 45 mg or placebo by subcutaneous injection every 4 weeks.

The primary endpoint was the composite of cardiovascular mortality and recurrent cardiovascular clinical events through week 140. Listed secondary endpoints included change from baseline in 6-minute walk test distance and Kansas City Cardiomyopathy Questionnaire overall summary score at week 140; total recurrent cardiovascular clinical events through week 140; all-cause mortality through weeks 140 and 160; the primary endpoint in patients receiving a TTR stabilizer at baseline; and cardiovascular mortality through weeks 140 and 160. The team also noted that eplontersen was generally well tolerated, with a safety profile described as consistent with previous results.

Regulatory Context and Next Steps for Eplontersen

Eplontersen is an RNA-targeted therapy designed to reduce the production of serum transthyretin at its source in the liver. In the United States, it is administered once monthly and can be self-administered using an autoinjector or given as a prefilled syringe by a health care professional, according to the companies.

Eplontersen is approved for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults in more than 20 countries, including in the European Union under the name Wainzua. The CARDIO-TTRansform results described in the announcement concern ATTR-CM and do not indicate a positive phase 3 outcome for that cardiomyopathy indication.

AstraZeneca and Ionis stated they will analyze the full data set to better characterize the findings. The companies plan to share results with the scientific community at the European Society of Cardiology (ESC) Congress in August 2026. Key unanswered issues include the magnitude of treatment effect in the overall study population, subgroup analyses by baseline stabilizer use, functional and quality-of-life outcomes, and complete safety data.

AstraZeneca. Update on CARDIO-TTRansform Phase III trial for Wainua (eplontersen) in adults with transthyretin-mediated amyloid cardiomyopathy. Published July 9, 2026. Accessed July 9, 2026. 

https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2026/update-cardio-ttransform-phase-iii-trial.html

AstraZeneca and Ionis reported that phase 3 CARDIO-TTRansform evaluating eplontersen (Wainua) in ATTR-CM failed to achieve the primary composite endpoint of cardiovascular mortality and recurrent cardiovascular clinical events through week 140 versus placebo when added to contemporary standard of care. High background transthyretin stabilizer use likely shaped interpretability; a nominally significant signal was described in an eplontersen monotherapy subgroup, with no effect among baseline stabilizer users. Safety was consistent with prior experience, but numerical efficacy and safety data were not disclosed pending presentation.

Eplontersen did not significantly reduce cardiovascular mortality and recurrent cardiovascular events in the phase 3 CARDIO-TTRansform trial.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Cardiomyopathy

Eplontersen Misses Primary Endpoint in Phase 3 ATTR-CM Trial

Rajani Katta, MD, clinical professor of dermatology at McGovern Medical School, University of Texas

Given the increase in popularity of hair, skin, and nail supplements, Rajani Katta, MD, is urging those in the dermatology field to take a more evidence-based approach to conversations on supplement use before recommending such products to patients.

Katta, known for her role as an author, a dermatologist, and a clinical faculty member at Baylor College of Medicine and McGovern Medical School at UTHealth, spoke in an interview with 

. She discussed the key messages from her presentation, ‘Supplements in Dermatology: An Evidence-Based Approach,’ highlighting the marketing of various widely available supplements with limited oversight despite their carrying potentially significant safety risks.

Throughout her talk and subsequent interview, Katta explained why both clinicians and patients often misunderstand the possible harms to the skin linked with supplement use. She also speaks about a practical framework for dermatologists to assess products before recommending them and touches on why long-term safety deserves an increased level of attention. The following Q&A includes her responses to related 

You gave a talk here at SDPA titled ‘Supplements in dermatology: an evidence-based approach.’ Why did you feel this topic was so important for clinicians working in the dermatology field today?

When we're talking about skin, hair, and nail supplements, they have exploded. We did a research study where we just looked at the ingredients of skin, hair, and nail supplements available on our local grocery stores. There were so many, and certainly a lot of patients and even providers don't realize all of the risks that are potentially associated with supplements, ranging from an increased risk of cancer to a risk of birth defects. So you really have to be educated on every single supplement ingredient, especially if you're going to recommend that to your patients.

 It seems as though the lack of FDA review of supplements is a notable concern. Do you feel that patients who may be anti-supplements should stay away from all of them or simply be more aware of the data on supplements?

I think it's really important to be aware of the data, but you're absolutely right. That is the main issue, and one of the things I talked about in my talk was the fact that for some pharmaceutical medications, you have to prove efficacy, you have to prove safety, you have to prove quality before a medication can be released. Sometimes patients don't realize that when you're buying a supplement, it seems like it should be safe and that somebody has checked it out. It's not the case, you know. The manufacturer does not have to prove effectiveness or safety. so you really have to educate yourself as a patient and as a provider.

Do you hear from any providers that you know of who are really misguided with regard to supplements? Do you feel that patients are more misguided regarding supplement use and impacts of skin health?

 That's a really good question. I'm not sure, but I will say…there’s an ingredient called saw palmetto, it’s found in some hair loss supplements, and when I've given talks, I've realized that not everybody realizes that that causes birth defects. So if you are recommending this particular supplement, you need to be telling every single woman of childbearing potential that this causes birth defects. I don't know how often that's happening.

What do you feel are some of the other most notable takeaways from your session?

I have a mnemonic: it's ‘PPIES’; for every single supplement that you are going to recommend or consider recommending P for purity, P for potency, I for interactions, E for efficacy, and S for safety. If nobody has double-checked the supplement for you, you need to do your own analysis of PPIES for every single ingredient in that supplement. That's really one of the main takeaways.

The second takeaway is that, at least for purity and potency, there is a shortcut, which is that you can look for a marker from an independent third-party investigative laboratory that says that they have at least evaluated this particular supplement for purity and potency. That way at least you can feel good about that. So that's an example of something that can help as a shortcut. There are no shortcuts, though, for trying to evaluate efficacy and safety. Unfortunately, that requires some research on your part.

 Do you feel that right now, given the increasing awareness of supplements and their potential dangers or upsides or downsides, that we're on a good track? Or do we have a long way to go?

I think we have a long way to go. I just hear a lot of patients using supplements without questioning if there a potential for risk here. I think they might have questions about if this is going to be effective. But I don't think enough patients say, ‘Could this harm me?’ Unfortunately, there's not a lot of long-term safety data. For example, there was just a study that came out about glucosamine, that's not really used for skin, hair, and nails, it's used for joint symptoms.

But the recent study came out showing that it increased the risk of dementia in patients who had been taking it long term. I worry about this, because we've seen this also with high dose vitamins and minerals, even things like vitamin B6 or beta-carotene, that [there is data suggesting] over the long term they can increase your risk of cancer. I think there aren't enough patients, or providers for that matter, asking these questions about what the long-term safety risk is here.

Disclosures: Katta has reported serving on an advisory board for Vichy Laboratories and is the author of a book on diet and dermatology for the general public.

Katta R. Integrative Medicine Track: Supplements in dermatology: an evidence-based approach. Session presented at SDPA Summer 2026; June 10–14.

Katta R. What Clinicians Should Know About Diet and Skin Disease, With Rajani Katta, MD. HCPLive. July 7, 2026. Accessed July 9, 2026. 

https://www.hcplive.com/view/what-clinicians-should-know-about-diet-skin-disease-rajani-katta-md

Skin, hair, and nail supplement use is surging, yet products reach consumers without premarket proof of efficacy, safety, or quality. Clinicians and patients often overlook clinically meaningful harms, including teratogenicity (eg, saw palmetto) and potential long‑term risks such as cancer signals with high‑dose vitamins/minerals. A practical evaluation framework—PPIES (purity, potency, interactions, efficacy, safety)—supports systematic counseling. Third‑party certification may help with purity/potency, but assessing efficacy and safety still requires independent literature review and heightened attention to long‑term outcomes. Counseling should explicitly address reproductive risk in women of childbearing potential.

This Q&A interview highlights Katta's views on dietary and nutritional supplements' impact on skin health as well as their long-term effects.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

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What Are the Side Effects of Hair and Skin Supplements in Dermatology? With Rajani Katta, MD

Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

Kimberly Brown, MD, is division chief of gastroenterology and hepatology and the Associate Medical Director of the Henry Ford Hospital Transplant Institute at Henry Ford Hospital. She is also a Professor of Medicine at Wayne State University

Tatyana Kushner, MD, is an associate professor of medicine in the division of gastroenterology and hepatology at Weill Cornell Medicine.

Liver Lineup: Updates & Unfiltered Insights

Liver Lineup: Bepirovirsen and the Push Toward Functional Cure in Hepatitis B

 has gone decades without a finite treatment option, but that may be about to change. On this episode of 

, hosts Nancy Reau, MD, and Kimberly Brown, MD, are joined by Tatyana Kushner, MD, a hepatologist at Weill Cornell Medicine, to discuss bepirovirsen, an investigational antisense oligonucleotide from GSK and Ionis Pharmaceuticals that recently became the first agent to demonstrate functional cure as a phase 3 primary endpoint in chronic hepatitis B (CHB).

Bepirovirsen Phase 3 Data in Chronic Hepatitis B

The conversation centers on data from the B-Well 1 and B-Well 2 trials, presented at the European Association for the Study of the Liver (EASL) Congress and simultaneously published in the New England Journal of Medicine in May 2026. The 2 replicate, double-blind, placebo-controlled trials enrolled 1834 participants across 29 countries with non-cirrhotic CHB who were on stable nucleos(t)ide analogue (NA) therapy and had baseline HBV DNA below 90 IU/mL and HBsAg between 100 and 3000 IU/mL, randomized 2:1 to weekly subcutaneous bepirovirsen 300 mg or placebo alongside standard NA therapy for 24 weeks.

Liver Lineup: HDV Diagnosis, Bulevirtide, and the Delta Pipeline

Liver Lineup: Closing the Gap in Women’s Liver Health

Liver Lineup: Navigating Genetic Testing in Cholestatic Liver Disease

Functional cure at week 72 was achieved in 20% of bepirovirsen-treated patients versus none of the placebo recipients in B-Well 1, and 19% versus 0% in B-Well 2, with response rates climbing further in patients with lower baseline HBsAg — up to 28% among those with baseline HBsAg of 1000 IU/mL or less. Sustained HBV DNA suppression after NA discontinuation, a key secondary endpoint, was reported in 23% of bepirovirsen-treated patients in both studies.

HBsAg Quantification and Patient Selection for Bepirovirsen

Kushner frames HBsAg quantification as the practical starting point for clinicians. She notes that she has begun routinely checking quantitative surface antigen in her own CHB patients, a test she previously considered non-actionable, because it will likely determine eligibility if bepirovirsen is approved. She cites discussion at a Coalition for Hepatitis Elimination conference suggesting roughly 50% to 60% of patients may fall under the HBsAg 3000 IU/mL threshold, though she, Reau, and Brown all note their own clinical experience suggests a lower proportion, complicated by limited access to quantitative, rather than qualitative, assays at some institutions.

Much of the discussion also addresses what functional cure means relative to spontaneous HBsAg loss and continued NA therapy; the group converges on sustained off-treatment HBsAg loss as the accepted endpoint, given its association with reduced HCC and cirrhosis progression risk, while acknowledging open questions about durability beyond the trial window.

Bepirovirsen Dosing, Monitoring, and Safety Considerations

The panel works through practical rollout questions: the drug's weekly injection schedule and potential for at-home administration, and the intensive monitoring likely required in the first 12 weeks given signals for ALT elevation and renal effects. The group agrees cirrhotic and decompensated patients, who were not studied, are unlikely candidates.

Brown highlights a discontinuation rate around 3% in the trials as reassuring relative to older interferon-based regimens, while Kushner cautions that real-world tolerance of ALT flares may differ from the closely monitored trial setting.

What's Next for Bepirovirsen in Hepatitis B Care

The conversation closes on access and uptake — whether primary care practices managing large hepatitis B populations, particularly in Asian American communities, will be positioned to administer and monitor this therapy, or whether care will concentrate in specialized centers. All 3 agree that regardless of uptake, an approval would likely drive renewed attention to hepatitis B screening and treatment linkage, areas where diagnosis and treatment rates in the US remain low.

Bepirovirsen is not yet approved; the FDA has accepted the New Drug Application for priority review and set a PDUFA goal date of October 26, 2026.

Hou J, et al. Phase 3 results of bepirovirsen treatment for chronic hepatitis B virus infection. 

Lok A. A major step toward a cure for hepatitis B infection. 

. 2026;394:2471-2472. doi:10.1056/NEJMe2605575

Brooks A. FDA Grants Bepirovirsen Breakthrough Therapy Designation, Priority Review for Chronic Hepatitis B. HCPLive. April 28, 2026. Accessed July 8, 2026. 

https://www.hcplive.com/view/fda-grants-bepirovirsen-breakthrough-therapy-designation-priority-review-for-chronic-hepatitis-b

Podcasts

Tatyana Kushner, MD, joins Kim Brown, MD, and Nancy Reau, MD, to unpack bepirovirsen's phase 3 data and its implications for HBV care.

Hepatology

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Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Introducing Liver Lineup: Updates & Unfiltered Insights — an exciting new podcast delivering timely, candid perspectives on the most pressing topics in the fast-moving world of hepatology. Created by Nancy Reau, MD, and Kimberly Brown, MD, and hosted by HCPLive, this series dives into the cutting edge of liver disease research, clinical care, and real-world practice.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Abigail Brooks is a strategic content lead overseeing 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

Freenome reported top-line results for an updated version of its SimpleScreen CRC blood-based colorectal cancer screening test, with the pivotal clinical validation study meeting primary and secondary endpoints, according to a July 9, 2026, announcement.

The updated assay and algorithm showed 80.4% sensitivity for colorectal cancer (CRC), 18.2% sensitivity for advanced precancerous lesions (APLs), 41.9% sensitivity for APLs with high-grade dysplasia (HGD), and 90% specificity among participants with no findings on colonoscopy, the company reported.

"The sensitivity for APL and APL with HGD for the updated SimpleScreen CRC test is a marked improvement and gets us closer to matching the performance of certain stool-based CRC screening tests, with potentially higher adherence," Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study, said in a statement.

What the SimpleScreen CRC Validation Study Reported

The clinical validation analysis used samples from PREEMPT CRC, a prospective registrational study conducted at more than 200 sites. The parent study enrolled 48,995 asymptomatic, average-risk adults aged 45 to 85 years who were scheduled to undergo screening colonoscopy.

 Freenome stated the updated test validation included blinded, previously unevaluated samples from PREEMPT CRC, along with previously tested samples.

The analysis included 89 individuals with CRC, 1570 with APLs, and 157 with APLs with HGD in the US Census–weighted endpoint analysis. Sensitivity for CRC was 80.4% (95% CI, 70.2%-87.7%). By stage, sensitivity was 52% for stage I CRC, including 39.9% for T1 and 81.2% for T2 disease, 100% for stage II, 97.3% for stage III, and 100% for stage IV CRC.

For precancerous lesions, sensitivity was 18.2% (95% CI, 16.3%-20.4%) for APLs and 41.9% (95% CI, 34.0%-50.3%) for APLs with HGD. Freenome compared these findings with its first-generation SimpleScreen CRC test, which showed 81.1% CRC sensitivity, 13.7% APL sensitivity, and 30.5% HGD sensitivity in PREEMPT CRC.

 The company described the improvement in lesion detection as driven by assay and algorithm updates.

"This study marks a major milestone in our mission to advance blood-based colorectal cancer screening," said Aaron Elliott, PhD, CEO of Freenome. "The significant improvement in detecting precancerous lesions demonstrates the critical role our SimpleScreen CRC platform can play in early detection and prevention of colon cancer. With millions of eligible Americans still not getting screened, expanding access to accurate, non-invasive screening options that patients are more likely to complete has never been more important."

FDA Review and Colorectal Cancer Screening Context

Freenome submitted a premarket approval application to the US Food and Drug Administration (FDA) in August 2025 for the first-generation SimpleScreen CRC test and stated agency review was expected to be completed in mid 2026. The company plans to submit a supplemental premarket approval application for the updated test.

Current US Preventive Services Task Force recommendations support CRC screening for adults aged 45 to 75 years, with individualized decisions for adults aged 76 to 85 years.

 Recommended strategies include stool-based tests, direct visualization, and other approved approaches. Blood-based CRC screening tests are being studied as a less invasive option, particularly for individuals who do not complete currently recommended screening, but performance characteristics vary by test and endpoint.

Freenome stated more than 50 million eligible US adults are not up to date with recommended CRC screening.

 The company also reported modeling projected the updated version, compared with its first-generation test, would produce 1582 additional life-years gained, 426 fewer CRC cases, and 143 fewer CRC deaths per 100,000 screened individuals.

Safety, Limitations, and Next Steps for SimpleScreen CRC

The July 9 announcement did not report adverse event data or blood draw–related safety findings. The main reported performance measures were sensitivity for CRC, sensitivity for APLs, sensitivity for APLs with HGD, and specificity among individuals with no colonoscopy findings.

The company’s first-generation SimpleScreen CRC results were previously published in JAMA in 2025.

 In the new announcement, Freenome characterized the updated test as a next-generation version based on assay and algorithm improvements. Freenome also noted its commercial collaboration with Abbott, under which Abbott would commercialize SimpleScreen CRC after FDA approval.

The regulatory status of the updated assay will depend on FDA review of the planned supplemental submission.

Freenome Holdings, Inc. Freenome reports top-line readout of updated SimpleScreen CRC colorectal cancer screening blood test met all primary and secondary endpoints. PR Newswire. Published July 9, 2026. 

https://www.prnewswire.com/news-releases/freenome-reports-top-line-readout-of-updated-simplescreen-crc-colorectal-cancer-screening-blood-test-met-all-primary-and-secondary-endpoints-302821493.html

Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer. JAMA. Published online June 2, 2025. doi:10.1001/jama.2025.7515

US Preventive Services Task Force. Screening for colorectal cancer: US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977. doi:10.1001/jama.2021.6238

Freenome’s updated SimpleScreen CRC blood test achieved 80.4% colorectal cancer sensitivity and 90% specificity in a large prospective registrational cohort, with improved detection of advanced precancerous lesions (18.2%) and high-grade dysplasia (41.9%). Stage-stratified performance showed limited stage I sensitivity (52%) but near-complete sensitivity for stages II–IV. Assay and algorithm refinements drove gains versus the first-generation test. Regulatory plans include a supplemental PMA following an initial PMA submission, alongside commercialization expectations via Abbott to address persistent screening gaps.

Freenome reported updated SimpleScreen CRC results showing 80.4% colorectal cancer sensitivity and 90% specificity.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

SimpleScreen CRC Blood Test Meets Endpoints in Clinical Validation Study

Videos

Learn how validating families and treating pediatric IBS/constipation as gut–brain disorders boosts adherence and focuses care on daily life.

Video Series

Shared Decision-Making, Adherence, and Future Directions in Pediatric IBS-C and Functional Constipation

Saakshi Khattri, MD, is a board certified Dermatologist, Rheumatologist and Internist and one of only a handful of triple board-certified physicians across the US.

Saakshi Khattri, MD, describes how risk factors for psoriatic arthritis influence her decision to use IL-23 inhibitors such as risankizumab as first-line systemic therapy in psoriasis.

First-Line Biologic Selection in High-Risk Psoriasis: The Role of IL-23 Inhibition

Richard Shi, MD, is a vascular surgery resident at the Medical University of South Carolina.

Richard Shi, MD, and Adam Tanious, MD, MBA, discuss the importance of exercise, medical interventions, and smoking cessation for PAD care.

Structural Heart Disease

Guideline-Directed Care Improves Limb Outcomes in Peripheral Artery Disease

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

This review highlights some of the most notable stories covered by the HCPLive team within the first half of 2026.

Plaque Psoriasis

The HCPLive plaque psoriasis page is a resource for medical news and expert insights on psoriasis. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for psoriatic disease, and more.

First Half 2026 Recap: Dermatology

Hilary Baldwin, MD, medical director of the Acne Treatment & Research Center at Atlantic Health and associate professor of dermatology at SUNY Downstate Medical Center. 

At Maui Derm Summer 2026, Hilary Baldwin, MD, used a single theoretical patient to illustrate how rosacea subtypes evolve and how treatment should follow suit.

From Red-Cheeked Baby to Bulbous Nose: Rosacea, Start to Finish 

Susanne McDevitt, DNP, ACNP-BC, Acute Care Nurse Practitioner in the Pulmonary Hypertension Program at Michigan Medicine, University of Michigan, Ann Arbor

From tighter hemodynamic definitions to a first-in-class activin signaling inhibitor, a nearly 30-year PH veteran says the field has never had more to offer patients — or more complexity to manage.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Navigating a New Era of PH Management as an APP, With Susanne McDevitt, DNP

Vlado Perkovic is Dean and Scientia Professor of Medicine at UNSW Sydney. He is also a Professorial Fellow at The George Institute and a Staff Specialist in Nephrology at the Royal North Shore Hospital in Sydney.

Sibeprenlimab preserved kidney function over 12 months in adults with IgA nephropathy in interim phase 3 VISIONARY trial findings.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Interim Phase 3 VISIONARY Data Show Sibeprenlimab Preserved Kidney Function in IgA Nephropathy

Rhea Votipka, AGACNP-BC, Adult Gerontology Acute Care Nurse Practitioner at Lahey Hospital and Medical Center and Assistant Professor of Medicine at UMass Chan Medical School,

From personalized sepsis resuscitation to the long-awaited ketamine versus etomidate verdict, a critical care NP highlights the evidence that defined the field last year.


Trials and Guidelines Shaping Critical Care, With Rhea Votipka, NP

An expert outlines a practical framework for diagnosis, treatment initiation, and dose optimization in children with growth hormone deficiency.

Best Practices for Initiating and Optimizing Growth Hormone Therapy in Pediatric GHD

A critical care NP and POCUS educator says point-of-care ultrasound competency is no longer optional for pulmonary and critical care APPs.

Latest News

Biologic Therapy for Asthma and COPD: Real-World Perspectives From APPs

Eplontersen Misses Primary Endpoint in Phase 3 ATTR-CM Trial

What Are the Side Effects of Hair and Skin Supplements in Dermatology? With Rajani Katta, MD

Liver Lineup: Bepirovirsen and the Push Toward Functional Cure in Hepatitis B

SimpleScreen CRC Blood Test Meets Endpoints in Clinical Validation Study