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 various hobbies. You can reach her at vjohnson@mjhlifesciences.com.

Pulmonology news in October 2026 was defined largely by the 

American College of Chest Physicians (CHEST) 2026 Annual Meeting

, held October 18-21 in Phoenix, Arizona, which supplied much of the month's clinical data. The month's most consequential regulatory story arrived October 30, when the US Food and Drug Administration (FDA) granted accelerated approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd; Inovio) to reduce the frequency of surgical papilloma excisions in adults with recurrent respiratory papillomatosis (RRP). It is the first plasmid DNA-based immunotherapy approved in the US. 

 In pulmonary vascular and interstitial lung disease, a risk-stratified analysis of the phase 3 ADVANCE OUTCOMES trial found that ralinepag reduced clinical worsening in pulmonary arterial hypertension, including among patients meeting low-risk criteria. A post hoc analysis of the phase 3 TETON-2 trial found fewer total progression events with inhaled treprostinil than placebo in idiopathic pulmonary fibrosis (126 vs 161; 

 =.003). In obstructive airway disease, tozorakimab improved patient-reported daily respiratory symptoms in the OBERON and TITANIA trials in COPD. An integrated SWIFT/AGILE analysis found that clinical remission with depemokimab at year 1 was associated with fewer asthma exacerbations in year 2. An ASPEN post hoc analysis linked patient-reported sputum color to neutrophil serine protease activity in bronchiectasis. HCPLive's on-site interviews also covered nalbuphine extended-release for IPF cough, AD109 in obstructive sleep apnea, and robotic bronchoscopy. 

Check out this October 2026 pulmonology month in review for full coverage of these stories and more.

Voceryq Gains FDA Accelerated Approval for Recurrent Respiratory Papillomatosis

Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd; Inovio) is a plasmid DNA-based immunotherapy that delivers 1 plasmid encoding HPV-6 and HPV-11 antigens and a second encoding interleukin-12. It is given intramuscularly with the CELLECTRA 5PSP electroporation device over a 9-week regimen. The FDA granted accelerated approval October 30, 2026, to reduce the frequency of surgical papilloma excisions in adults with RRP, based on the RRP-001 trial, in which 27% (7/26; 95% CI, 12%–48%) of patients with 3 or more surgeries in the prior 12 months had a complete response through 12 months of follow-up. RRP-001 had no control arm, and Inovio plans to submit a draft confirmatory trial protocol to the FDA by the end of 2026.

The CHEST 2026 Annual Meeting brought new data across interstitial lung disease, COPD, severe asthma, sleep medicine, and interventional pulmonology, including 3 late-breaking abstracts. In this edition of the HCPLive Five, investigators discuss nalbuphine extended-release for IPF cough, tozorakimab in COPD, depemokimab remission, AD109 in obstructive sleep apnea, and robotic bronchoscopy.

Ralinepag Cuts PAH Worsening in Low-Risk Patients, With Jean Elwing, MD

Ralinepag, an investigational once-daily oral prostacyclin receptor agonist, reduced the risk of clinical worsening by 55% vs placebo in the phase 3 ADVANCE OUTCOMES trial (HR, 0.45; 95% CI, 0.33–0.62; 

 <.0001). A CHEST 2026 subgroup analysis stratified participants by 3 noninvasive low-risk criteria: NT-proBNP below 300 pg/mL, 6-minute walk distance above 440 m, and WHO functional class I or II. Jean Elwing, MD, of the University of Cincinnati College of Medicine, said patients who met all 3 criteria still had fewer clinical worsening events with ralinepag. Those who met none had an HR of 0.60 with a confidence interval crossing 1.0. The FDA has accepted the new drug application with a PDUFA date of June 24, 2027.

Depemokimab Year 1 Remission Linked to Better Year 2 Asthma Outcomes

In SWIFT-1/-2, 29% of patients with type 2 asthma receiving twice-yearly depemokimab (Exdensur; GSK) achieved 4-component clinical remission at week 52, vs 23% with placebo. An integrated SWIFT/AGILE analysis presented at CHEST 2026 by Michael Wechsler, MD, found that 59% of patients in remission at year 1 remained in remission at year 2. Year 2 annualized exacerbation rates were 0.19 (95% CI, 0.12–0.29) among patients in remission at year 1 vs 0.69 (95% CI, 0.57–0.82) among those not in remission. Patients in remission at year 1 also showed greater improvement across all 3 secondary outcomes at year 2. The analysis is observational and shows association, not causation.

Tozorakimab Improves Daily Respiratory Symptoms in COPD: OBERON, TITANIA

Tozorakimab (AstraZeneca), an anti–IL-33 monoclonal antibody, 300 mg every 4 weeks improved Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total scores vs placebo at week 52 in both phase 3 OBERON and TITANIA trials. Improvements spanned the breathlessness, cough/sputum, and chest symptom domains, according to an analysis presented at CHEST 2026. Frank Sciurba, MD, of the University of Pittsburgh, said symptom benefit matters to patients independent of exacerbation risk reduction. In the primary population of former smokers, the trials previously showed 29% and 34% reductions in moderate and severe exacerbations, respectively. The FDA has accepted the biologics license application for COPD under Priority Review, with a PDUFA date anticipated in the first quarter of 2027.

Sputum Color Flags Severity in Bronchiectasis: James Chalmers, MBChB, PhD

A post hoc analysis of the phase 3 ASPEN trial, presented at CHEST 2026, found that patient-reported sputum color reflected neutrophil serine protease activity and overall disease activity in bronchiectasis. Participants rated sputum color daily on a 6-point scale in the Bronchiectasis Exacerbation and Symptom Tool diary. Greater baseline purulence was associated with higher sputum neutrophil counts, 

 positivity, exacerbation rates, and Bronchiectasis-Computed Tomography scores, as well as lower postbronchodilator percent predicted forced expiratory volume in 1 second. Brensocatib (Brinsupri) reduced neutrophil elastase activity across all sputum color categories. James Chalmers, MBChB, PhD, of the University of Oxford, said patients with mucoid sputum can still be inflamed and benefit, which is relevant to growing interest in treating earlier disease.

Inhaled Treprostinil After IPF Progression, With Steven Nathan, MD

A post hoc analysis of the phase 3 TETON-2 trial, presented at CHEST 2026, counted every disease progression event across 52 weeks instead of only the first. In total, 126 events occurred in 82 patients receiving inhaled treprostinil (Tyvaso; United Therapeutics) vs 161 events in 115 patients receiving placebo (

 =.003). The difference was driven mainly by relative declines of 10% or more in percent predicted forced vital capacity (54 vs 86 events) and concurrent IPF exacerbation with respiratory hospitalization (6 vs 18 events). Adjudicated respiratory hospitalizations were numerically more frequent with inhaled treprostinil (45 vs 34 events), and the number of patients with more than 1 event did not differ significantly (26 vs 36; 

 =.166). Steven D. Nathan, MD, of Inova and the University of Virginia, said the findings support continuing therapy after a first progression event. Inhaled treprostinil remains investigational for IPF, with FDA review of the supplemental new drug application expected to be complete in late April 2027.

Brooks A. Voceryq Gains FDA Accelerated Approval for Recurrent Respiratory Papillomatosis. HCPLive. October 30, 2026. 

https://www.hcplive.com/view/voceryq-gains-fda-accelerated-approval-for-recurrent-respiratory-papillomatosis

Derman C. HCPLive Five at CHEST 2026. HCPLive. October 30, 2026. 

https://www.hcplive.com/view/hcplive-five-chest-2026

Ralinepag Cuts PAH Worsening in Low-Risk Patients, With Jean Elwing, MD. HCPLive. October 23, 2026. 

https://www.hcplive.com/view/ralinepag-cuts-pah-worsening-low-risk-patients-elwing

Depemokimab Year 1 Remission Linked to Better Year 2 Asthma Outcomes. HCPLive. October 21, 2026. 

https://www.hcplive.com/view/depemokimab-year-1-remission-linked-better-year-2-asthma-outcomes

Tozorakimab Improves Daily Respiratory Symptoms in COPD: OBERON, TITANIA. HCPLive. October 21, 2026. 

https://www.hcplive.com/view/tozorakimab-improves-daily-respiratory-symptoms-copd-oberon-titania

Sputum Color Flags Severity in Bronchiectasis: James Chalmers, MBChB, PhD. HCPLive. October 30, 2026. 

https://www.hcplive.com/view/sputum-color-flags-severity-bronchiectasis-chalmers

Nathan SD. Inhaled Treprostinil After IPF Progression, With Steven Nathan, MD. HCPLive. November 2, 2026. 

https://www.hcplive.com/view/inhaled-treprostinil-ipf-progression

Articles

October 2026 pulmonology highlights include FDA accelerated approval of Voceryq for recurrent respiratory papillomatosis and CHEST 2026 data.

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.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

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.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

7 Pulmonology Headlines You Missed in October

Elevated cardiovascular inflammation (CVI) affects roughly 50% of US patients with 

 across the spectrum, potentially corresponding to HF severity through higher IL-6 and NT-proBNP.

Higher Cardiovascular Inflammation Prevalent Across All Heart Failure Subtypes

These data, a subanalysis of the POSEIDON study, were presented at the 

Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026

 in Phoenix, Arizona, by Marat Fudim, MD, an associate professor at Duke University Health and a member of the American Heart Association’s Heart Technology Advisory Group.

“The real reason this registry was put into place is because there is a cadre of clinical trials going on – a couple of these trials were halted and are going to be terminated because there was no apparent benefit to blocking IL-6 versus placebo,” Fudim told 

 in an exclusive interview. “Now this is very disappointing, but it does not mean that this registry has no value anymore. Quite the opposite: it shows that we may have lost the battle, but we have not lost the war.”

POSEIDON was a cross-sectional, global, real-world prevalence study spanning 317 sites in 18 countries. Patients were eligible if they had atherosclerotic cardiovascular disease (ASCVD) and/or HF, as well as serum creatinine in the medical chart within 24 months prior to signing of informed consent. Patients with a hospitalization of any kind within the last 60 days or clinical evidence or suspicion of active infection within the same period, among other criteria, were excluded.

The POSEIDON study ultimately enrolled 18,904 individuals, including 11,809 with HF and available hsCRP. Of these, 3714 had preserved ejection fraction (HFpEF), 2176 had mildly reduced EF (HFmrEF), and 5919 had reduced EF (HFrEF). Elevated hsCRP was found in 1442 patients with HFpEF, 830 with HFmrEF, and 2263 with HFrEF. In each subtype, patients with elevated hsCRP were more likely to be female and have chronic kidney disease (CKD), obesity, worse functional class, and higher NT-proBNP. These predictors were also consistent across HF subtypes, with the exception of body mass index (BMI).

In the present analysis, Fudim and colleagues brought a cohort of US-based patients from the POSEIDON study into the clinic for a singular study visit with a blood sample collection. A total of 810 patients were included in this substudy, and CVI risk was categorized as either low (hsCRP <2 mg/L) or high (hsCRP ≥2 mg/L). Of these patients, 315 had HFpEF, 94 had HFmrEF, and 392 had HFrEF.

Fudim and colleagues found that nearly 50% of patients across the HF spectrum had CVI risk: in the HFpEF group, 49% of patients had hsCRP ≥2 mg/L, while 55% in the HFmrEF group and 50% in the HFrEF group had hsCRP ≥2 mg/L. The team noted that these measures represented residual inflammatory risk persisting despite current management; additionally, CVI risk was numerically higher in the US cohort than in the global POSEIDON study. The team also recorded a potential association between hsCRP ≥2 mg/L and higher IL-6 and NT-proBNP across all HF phenotypes and risk subgroups.

Ultimately, Fudim and colleagues noted that CVI risk may potentially provide a link between inflammatory pathway activation and HF severity. They also noted that its frequent presence across all HF phenotypes could present an opportunity for further research into anti-inflammatory approaches to reducing cardiovascular risk.

“First of all, I would want to know if treatment of inflammation really results in better outcomes; we haven’t had many successful stories there,” Fudim said. “That’s A. B is whether the risk of CVI change over time in the same individuals. It would have been nice to longitudinally track and see if people change their risk over time, and then to also understand what it is that led to that risk reclassification. So, yes, longitudinal data would be amazing.”

Editors’ Note: Fudim reports disclosures with Alleviant, the American Heart Association, Bayer, Impulse Dynamics, Novo Nordisk, Summacor, and others.

Fudim M, Contreras J, Ibrahim H, et al. Prevalence of Cardiovascular Inflammation and Associated Patient Characteristics and Biomarker Profiles Across the Heart Failure Spectrum in the United States: Results From the POSEIDON Study. Presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2026, Phoenix, AZ. October 9-12, 2026.

Novo Nordisk A/S. Levels of Inflammation in People With Cardiovascular Disease (POSEIDON) (POSEIDON). ClinicalTrials.gov Identifier: NCT06122961. Updated May 9, 2026. Accessed November 4, 2026. 

https://clinicaltrials.gov/study/NCT06122961?term=NCT06122961&rank=1

Lam CS, Contreras J, Darwesh R, et al. Prevalence and predictors of high inflammatory risk in heart failure subtypes: Findings from the Global Poseidon Study. European Journal of Heart Failure. Published online May 10, 2026. 

Videos

Marat Fudim, MD, discusses his analysis of a US cohort from the POSEIDON study, which found a potential association between CVI and HF severity.

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...

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Strategic Alliance Partnership

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for 

. He is also the executive producer of two podcasts: 

. 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.

’s team is providing on-site coverage of the 

2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) International COPD Conference

, held November 5 to 6 at the Pennsylvania Convention Center in Philadelphia, featuring a presentation of the 2027 GOLD Report and interviews with leaders in 

chronic obstructive pulmonary disease (COPD)

Now in its 11th year, the meeting is co-hosted by the Temple Lung Center and co-sponsored by GOLD, with Gerard Criner, MD, director of the Temple Lung Center, opening and closing each day.²,³ It offers up to 8.5 

™ through Integrity CE, LLC, with sessions available in person and virtually.¹

Over the course of this 2-day meeting, pulmonologists, primary care clinicians, advanced practice providers, pharmacists, and respiratory therapists will convene to review the latest GOLD strategy, emerging therapeutic targets, and approaches to earlier diagnosis and exacerbation prevention.

What to Expect at GOLD 2026 in Philadelphia:

This year’s program opens with COPD Essentials, a pre-conference course on translating the GOLD strategy into practice, followed by 7 main sessions, CME symposia, and industry product theaters.² Topics span mucus plugging, exacerbation definitions, multimorbidity, proactive diagnosis, neutrophilic inflammation, type 2 inflammation, and alarmin-targeted therapy.²

 will be on-site throughout the conference, providing exclusive interviews with COPD leaders, coverage of notable sessions, and reporting on the latest clinical insights shared during the meeting.

 Shawn Aaron, MD, reviews initial therapy and early management strategies under the GOLD ABE framework (Thursday, November 5)

 David MG Halpin, MA, DPhil, MBBS, FRCP, FERS, discusses how to choose the best inhaler for each patient, following a device review from Ed Portillo, PharmD (Thursday, November 5)

 Criner covers advanced supportive therapies and respiratory support in COPD (Thursday, November 5)

 Dave Singh, MD, addresses disease stability and how clinicians can recognize when additional therapy is needed (Thursday, November 5)

Among the many sessions on this year’s agenda, the following offer practical updates for clinicians attending the conference.

Role of Mucus in Disease Progression in COPD

Thursday, November 5 • 2:05–3:20 PM ET • Terrace Ballroom I

 Moderated by Criner and María Montes de Oca, MD, PhD, this session examines the burden of mucus plugging in moderate to severe COPD, the role of type 2 cytokines in mucus plug formation, and precision approaches to targeting mucus. Speakers include Emily Wan, MD, MPH; Monica Kraft, MD; and Mario Castro, MD, MPH.

Thursday, November 5 • 3:45–5:05 PM ET • Terrace Ballroom I

 Jadwiga A. Wedzicha, MD, moderates a session on why updated exacerbation definitions are needed, whether the Rome proposal works in practice, and which tests to order in the emergency department or hospital. Faculty include Leonardo M. Fabbri, MD, FERS; Bartolome R. Celli, MD; and Carlos A. Camargo, MD, DrPH.

Multimorbidity in Patients With COPD: What Can We Do About It?

Thursday, November 5 • 6:25–7:40 PM ET • Terrace Ballroom I

 Fabbri and Celli lead a look at multimorbidity in COPD, including the 5 M’s framework and the cardiovascular and respiratory clusters. Faculty include Nathaniel Hawkins, MBChB, MD, MPH, and Frits Franssen, MD, PhD.

Moving to a Proactive Approach to the Diagnosis, Assessment and Management of COPD

Friday, November 6 • 8:10–9:45 AM ET • Terrace Ballroom I

 Moderated by Claus Vogelmeier, MD, and Alvar Agusti, MD, this session addresses the underdiagnosis gap in COPD, case-finding in the community, the case for preventing every exacerbation, and how to define disease stability. Speakers include Agusti, Aaron, Halpin, and Singh.

Targeting Neutrophilic Inflammation in COPD

Friday, November 6 • 11:05 AM–12:20 PM ET • Terrace Ballroom I

 Stephen Rennard, MD; Charlie Strange, MD; and James D. Chalmers, MBChB, PhD, will review the role of neutrophilic inflammation in COPD, elastase inhibition, and dipeptidyl peptidase 1 (DPP1) inhibition in bronchiectasis, including in patients with COPD. Robert A. Sandhaus, MD, PhD, and Montes de Oca moderate.

2027 GOLD Report and Review/COPD Call to Action

Friday, November 6 • 1:35–2:25 PM ET • Terrace Ballroom I

 Vogelmeier and Agusti will present the 2027 GOLD Report, followed by audience questions. Obianuju Ozoh, MBBS, MSc, and Jinping Zheng, MD, moderate.

Targeting Pathways in COPD: A Glimpse Into the Future?

Friday, November 6 • 3:45–5:00 PM ET • Terrace Ballroom I

 Moderated by Singh, this session explores airway immunology in the biologic era, lessons from type 2 inflammation in asthma, and alarmin-targeted approaches to epithelial health. Faculty include Lena Uller, PhD, MSc; Guy Brusselle, MD, PhD, FERS; and Wedzicha.

The HCPLive team will provide ongoing coverage from Philadelphia, including session highlights, expert interviews, and key clinical takeaways from the 2026 GOLD International COPD Conference.

Editor’s note: This summary was created with the help of AI tools.

Integrity Continuing Education. 2026 Global Initiative for Chronic Obstructive Lung Disease (GOLD) International Chronic Obstructive Pulmonary Disease (COPD) Conference. eMedEvents. Accessed November 4, 2026. 

https://www.emedevents.com/medical-hybrid-events-2026/2026-global-initiative-for-chronic-obstructive-lung-disease-gold-international-chronic-obstructive-pulmonary-disease-copd-conference

2026 GOLD International COPD Conference agenda. Accessed November 4, 2026.

Temple Health. Temple co-hosts 2024 GOLD International COPD Conference. Accessed November 4, 2026. 

https://www.templehealth.org/about/news/temple-co-hosts-2024-gold-international-copd-conference

HCPLive previews GOLD 2026 in Philadelphia, November 5-6, with sessions on the 2027 GOLD Report, mucus plugging, and exacerbations, plus expert interviews.

Conference Preview: 2026 GOLD International COPD Conference

Whether initiating complement-targeted treatment earlier can improve long-term kidney outcomes in patients with 

 or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) remains an open question. Bradley P. Dixon, MD, FASN, argues that waiting for conventional immunosuppression to fail could allow kidney damage to accumulate before targeted therapy begins.

Dixon, associate professor of pediatrics and medicine and head of the Section of Nephrology at the University of Colorado School of Medicine, discussed the rationale for earlier intervention in an interview with 

 following his presentation of 76-week adolescent data from the phase 3 VALIANT trial and its VALE extension at the 

American Society of Nephrology (ASN) Kidney Week 2026

Could Earlier Complement Inhibition Preserve Kidney Function in C3G?

The available VALIANT+VALE data do not directly establish whether initiating complement inhibition earlier produces better long-term outcomes than delayed treatment.

Heavy Proteinuria Despite Preserved Kidney Function

In the post hoc VALIANT+VALE adolescent analysis, investigators reported outcomes from 53 patients aged 12 to 17 years who received pegcetacoplan (Empaveli), a C3 and C3b inhibitor, over 76 weeks. The geometric mean change in urine protein-to-creatinine ratio (UPCR) from baseline was –67.5% (95% CI, –77.0 to –54.1), while estimated glomerular filtration rate (eGFR) remained stable (least squares mean change, +8.4 mL/min/1.73 m²; SE, 4.43).¹

Pegcetacoplan Sustains Proteinuria Reduction at 76 Weeks in Adolescents

Dixon emphasized that the adolescents entered treatment with substantial proteinuria but relatively preserved kidney function. He views that combination as an opportunity to intervene before further loss of kidney function occurs.

“I think this highlights that these adolescent patients in particular had significant disease burden with heavy proteinuria, but also had relatively preserved kidney function,” Dixon said. “And I think a take-home message from this data, especially with the preservation in kidney function over a longer-term exposure, is that intervening early in patients with C3 glomerulopathy and immune complex MPGN does allow for greater preservation of kidney function. So time is kidney.”

The longer-term analysis demonstrated sustained proteinuria reduction and stable eGFR during treatment. Because it was a post hoc analysis of treatment exposure across VALIANT and its open-label extension, however, it cannot determine whether earlier treatment initiation prevents kidney function decline compared with later initiation.

Does Baseline Kidney Damage Influence Treatment Outcomes?

A separate 76-week analysis of the overall VALIANT+VALE population examined outcomes according to the extent of interstitial fibrosis and tubular atrophy (IFTA) at baseline, a measure of chronic kidney damage.²

Proteinuria decreased in both baseline IFTA subgroups. At week 76, the geometric mean reduction was 66.8% among patients with IFTA of 25% or less (n = 94), compared with 52.6% among those with IFTA of 26% to 50% (n = 23).²

Differences also emerged in kidney function. The least squares mean change in eGFR was +1.7 mL/min/1.73 m² (95% CI, –3.9 to 7.3) in the lower-IFTA subgroup, compared with –11.0 mL/min/1.73 m² (95% CI, –20.3 to –1.6) in the higher-IFTA subgroup.²

These exploratory findings suggest that baseline chronic kidney damage may influence kidney function trajectories during treatment. However, the subgroup sizes were unequal, and the analysis did not randomize patients according to treatment timing. The findings therefore cannot establish that earlier complement inhibition would have prevented the greater decline observed among patients with more extensive baseline fibrosis.

Weighing Infection Risk Against Conventional Immunosuppression

Safety remains an important consideration in decisions about complement inhibition. Pegcetacoplan carries an FDA boxed warning for serious and potentially life-threatening infections caused by encapsulated bacteria, including 

The prescribing information requires appropriate vaccination against encapsulated bacteria, generally at least 2 weeks before treatment initiation. When urgent treatment cannot be delayed and vaccination is not up to date, antibacterial prophylaxis is recommended. Vaccination does not eliminate the risk of serious infection, and pegcetacoplan is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program.³

Dixon acknowledged these risks but questioned the assumption that conventional immunosuppressive therapies necessarily carry a more favorable safety profile.

“It’s true that infection risk is associated with these medicines, and that risk has to be mitigated with vaccination and careful surveillance, but I think the misconception is that untargeted immunosuppression is safer,” he said. “I would argue that these medications also greatly increase the risk of infection, particularly opportunistic infections, and so at the end of the day, complement-targeted therapeutics with an appropriate risk mitigation strategy are actually safer than untargeted immunosuppression.”

The relative safety of these approaches remains an important distinction. VALIANT compared pegcetacoplan with placebo during its randomized period, not with a conventional immunosuppressive regimen. The trial therefore does not establish whether complement inhibition carries a lower overall infection risk than corticosteroids or mycophenolate-based treatment.

What the Findings Mean for Treatment Timing

The longer-term VALIANT+VALE results provide evidence of sustained proteinuria reduction and eGFR stabilization during pegcetacoplan treatment. The exploratory IFTA findings also raise questions about how existing kidney damage may influence outcomes.

Together, these findings provide context for Dixon's perspective on treatment timing, although additional comparative evidence is needed to determine which patients benefit most from earlier complement inhibition.

Dixon called for clinicians to reassess the safety and tolerability of complement-targeted therapies and to “really begin to use these earlier to achieve maximum benefit.”

Whether earlier initiation improves long-term kidney survival, and how its risks compare with conventional immunosuppression, remain questions requiring additional comparative evidence.

Editor's Note: Dixon reports relevant disclosures with Apellis Pharmaceuticals, Novartis, and others.

Dixon BP, Greenbaum LA, et al. Pegcetacoplan for 76 weeks maintains proteinuria reduction and eGFR stabilization for pediatric patients: VALIANT+VALE subgroup analysis. Abstract TH-OR070. Presented at: American Society of Nephrology Kidney Week 2026; October 22-25, 2026; Denver, CO. 

Nester CM, Bomback AS, et al. Pegcetacoplan for 76 weeks maintains proteinuria reduction and stabilizes kidney function in C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Abstract SA-OR054. Presented at: American Society of Nephrology Kidney Week 2026; October 22-25, 2026; Denver, CO. 

Empaveli (pegcetacoplan) injection, for subcutaneous use. Prescribing information. Apellis Pharmaceuticals, Inc. Revised August 2026. Accessed November 4, 2026. 

Bradley Dixon, MD, discusses VALIANT+VALE data showing sustained proteinuria reduction and stable eGFR through 76 weeks in adolescents with C3G or IC-MPGN.



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.

C3 Glomerulopathy

The HCPLive C3 glomerulopathy page is a resource for medical news and expert insights on C3G. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in C3G, and more.

Chronic Kidney Disease

 or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) maintained a nearly 68% reduction in proteinuria after 76 weeks of pegcetacoplan (Empaveli) treatment, with stable kidney function and no new safety signals, according to a post hoc analysis of the phase 3 VALIANT trial and its open-label extension, VALE.¹

Bradley P. Dixon, MD, FASN, associate professor of pediatrics and medicine and head of the Section of Nephrology at the University of Colorado School of Medicine, presented the findings at the 

 in Denver, Colorado. The results build on 

, providing longer-term evidence of sustained proteinuria reduction in adolescents receiving complement-targeted therapy.¹

Adolescents with C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) maintained a nearly 68% reduction in proteinuria after 76 weeks of pegcetacoplan (Empaveli) treatment, with stable kidney function and no new safety signals, according to a post hoc analysis of the phase 3 VALIANT trial and its open-label extension, VALE.¹  Bradley P. Dixon, MD, FASN, associate professor of pediatrics and medicine and head of the Section of Nephrology at the University of Colorado School of Medicine, presented the findings at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado. The results build on previously reported 52-week findings, providing longer-term evidence of sustained proteinuria reduction in adolescents receiving complement-targeted therapy.¹

Diagnostic Delays in Rare Complement-Mediated Kidney Disease

C3G and primary IC-MPGN are rare, chronic glomerular diseases associated with dysregulation of the complement system. Excessive complement activation can contribute to inflammation and progressive kidney damage, with both diseases frequently presenting during childhood or early adulthood.²

, a targeted C3 and C3b inhibitor, for patients aged 12 years and older with C3G or primary IC-MPGN. It was the first approved treatment for primary IC-MPGN and the first for adolescents with either disease.³ The indication was subsequently expanded in August 2026 to include reducing the loss of kidney function.⁴

Despite advances in treatment, disease rarity can complicate timely diagnosis.

“C3 glomerulopathy and immune complex MPGN are rare diseases, and so there can be a lack of familiarity with these diseases. I would say that’s more true for the adult nephrology population,” Dixon said in an interview with 

. “We in the pediatric nephrology world are more tuned into rare diseases, so we will diagnose these patients a little bit more quickly. But nevertheless, rare diseases can go undiagnosed for a longer period of time.”

Shifting the Treatment Paradigm for C3G and IC-MPGN

Historically, treatment for C3G and primary IC-MPGN has relied on supportive care and nonspecific immunosuppression, including corticosteroids and mycophenolate. Complement-targeted therapies offer an approach directed at a central mechanism of disease activity.

Kidney Disease: Improving Global Outcomes (KDIGO)

 guidance generally positioned complement therapeutics after conventional immunosuppressive treatment in patients with severe or refractory disease.

“That ultimately delays the initiation of targeted and highly effective therapies until some amount of damage has been done by uncontrolled disease activity,” Dixon said.

The concern is particularly relevant for adolescents, who may face decades of disease burden following diagnosis. Although the VALIANT+VALE analysis did not directly evaluate treatment timing, sustained proteinuria reduction and stable eGFR provide additional evidence of disease control during extended complement inhibition.

 The Case for Earlier Complement Inhibition in C3G, With Bradley Dixon, MD

VALIANT (NCT05067127) was a phase 3, randomized, placebo-controlled trial evaluating pegcetacoplan in patients with C3G or primary IC-MPGN. Participants were randomized 1:1 to receive subcutaneous pegcetacoplan or placebo twice weekly for 26 weeks, followed by a 26-week open-label period in which all participants received pegcetacoplan. Eligible participants could subsequently enter the VALE open-label extension (NCT05809531).¹,²

The initial randomized adolescent analysis included 55 patients aged 12 to 17 years, of whom 28 received pegcetacoplan and 27 received placebo. At week 26, pegcetacoplan was associated with a 75% relative reduction in proteinuria compared with placebo (95% CI, 59%–84%; nominal 

Additionally, 71% of adolescents receiving pegcetacoplan achieved at least a 50% reduction in proteinuria, compared with 4% receiving placebo. A composite kidney endpoint requiring both a reduction in proteinuria of at least 50% and no more than a 15% decline in eGFR was achieved by 57% and 4% of patients, respectively.²

For the 76-week post hoc analysis, investigators reported outcomes from 53 adolescents receiving pegcetacoplan across VALIANT and VALE. Results were aligned by duration of pegcetacoplan exposure, combining patients originally assigned to pegcetacoplan with those who crossed over from placebo. Efficacy endpoints included changes from baseline in urine protein-to-creatinine ratio (UPCR) and estimated glomerular filtration rate (eGFR), along with treatment-emergent adverse events.¹

Sustained Proteinuria Reduction and Stable eGFR Through 76 Weeks

At 76 weeks, the geometric mean reduction in UPCR from baseline was 67.5% (95% CI, 54.1%–77.0%). The reduction was consistent with findings at week 26 (68.4%) and week 52 (69.3%), suggesting the initial proteinuria response was maintained with continued treatment.¹

Kidney function also remained stable over the extended treatment period. At week 76, the least squares mean change in eGFR from baseline was +8.4 mL/min/1.73 m² (SE, 4.43).¹

The sustained response was consistent with findings from the overall VALIANT population, in which a separate 76-week analysis reported a 64.1% reduction in proteinuria and stable eGFR.⁵

No new safety signals were identified in the adolescent analysis through 76 weeks.¹

The findings support sustained proteinuria reduction and eGFR stabilization during pegcetacoplan treatment in adolescents with C3G or primary IC-MPGN. However, because the longer-term analysis was post hoc and lacked a concurrent placebo group after the randomized treatment period, it cannot establish the comparative benefit of extended treatment or whether earlier initiation prevents long-term kidney function decline.

For clinicians managing adolescents with these rare diseases, the results add to evidence supporting complement inhibition as a targeted treatment approach, while longer-term follow-up will be important for understanding its effects on kidney outcomes over time.

Dixon BP, Greenbaum LA, Ariceta Iraola G, et al. Pegcetacoplan for 76 weeks maintains proteinuria reduction and eGFR stabilization for pediatric patients: VALIANT+VALE subgroup analysis. Abstract TH-OR070. Presented at: American Society of Nephrology Kidney Week 2026; October 22-25, 2026; Denver, CO. 

https://www.asn-online.org/education/kidneyweek/2026/program-abstract.aspx?controlId=4555106

Vivarelli M, Ariceta G, Borovitz Y, et al. Pegcetacoplan for adolescents with C3 glomerulopathy or primary immune complex membranoproliferative GN: phase 3 VALIANT subgroup analysis. 

US Food and Drug Administration. Orphan drug designations and approvals: pegcetacoplan (Empaveli), C3 glomerulopathy. Accessed November 4, 2026. 

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=633418

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c23d89e9-b00b-4520-e053-2995a90a95af

Nester CM, Bomback AS, Ariceta Iraola G, et al. Pegcetacoplan for 76 weeks maintains proteinuria reduction and stabilizes kidney function in C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN). Abstract SA-OR054. Presented at: American Society of Nephrology Kidney Week 2026; October 22-25, 2026; Denver, CO. 

Latest News

7 Pulmonology Headlines You Missed in October

Higher Cardiovascular Inflammation Prevalent Across All Heart Failure Subtypes

Conference Preview: 2026 GOLD International COPD Conference

Could Earlier Complement Inhibition Preserve Kidney Function in C3G?

Pegcetacoplan Sustains Proteinuria Reduction at 76 Weeks in Adolescents