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.

Endocrinology made some substantial progress over the last 3 months, between new treatments approved by the 

 and key trial readouts across the spectrum of care. From diabetes and obesity to cardiovascular complications, several major facets of endocrinology saw major upgrades through new medications or topline evidence from new programs.

As we enter the fourth and final quarter of 2026, catch up on any headlines you may have missed with our quarter in review now:


FDA Approves Finerenone (Kerendia) for CKD and Type 1 Diabetes


Finerenone saw a label expansion approved by the FDA on September 17, 2026, marking the first new treatment option for 

 associated with T1D in >30 years. According to the announcement from Bayer, the approval was granted through the priority review system and was based on data from the FINE-ONE trial. This program saw finerenone outperform placebo in reducing the urine albumin-to-creatinine ratio over 6 months.


Tirzepatide Gets FDA Approval to Cut Cardiovascular Risk in Type 2 Diabetes


On August 28, the FDA approved tirzepatide for cardiovascular disease risk in patients with 

, based on the SURPASS-CVOT trial. Parent company Eli Lilly positioned this trial as a higher evidentiary bar, comparing tirzepatide to dulaglutide, which holds an established cardiovascular indication. Tirzepatide ultimately displayed noninferiority for a composite of cardiovascular death, heart attack, or stroke, allowing the FDA to provide clinicians with a new option for managing these events in this population with increased risk.


FDA Clears Beta Bionics' Mint Insulin Patch Pump for Diabetes


On September 14, 2026, the FDA cleared the Mint insulin patch pump from Beta Bionics, a 2-piece reusable and disposable system designed to be smaller than the leading Omnipod 5. Each patch is designed for 3 days of wear with a 12-hour grace period and contains a 200-unit insulin reservoir. Additionally, the pump will receive firmware updates over the air, avoiding the issue of phone re-pairing. Mint is expected to be commercially available in the first quarter of 2027.


Retatrutide Improves Weight Loss, Knee Osteoarthritis Pain, Sleep Apnea Versus Placebo


The TRIUMPH-1 study has demonstrated retatrutide’s substantial efficacy in reducing weight in obesity, improving pain in knee osteoarthritis, and reducing apnea-hypopnea events in obstructive sleep apnea. The GLP-1/GIP/glucagon triple agonist demonstrated its overwhelming efficacy, with body weight loss of roughly 25% at the highest dose compared with placebo. Additionally, retatrutide’s safety data was consistent with prior phase 2 trials, with the most common adverse events mild to moderate in severity.


Investigational Rapid-Acting U500 Insulin Maintains Efficacy Regardless of BMI


AT278, an investigational U500 rapid-acting insulin aspart formulation being developed by Arecor Therapeutics, demonstrated substantially greater glucose reduction among patients with T2D, regardless of body mass index. This phase 1 glucose clamp trial compared AT278 to InsAsp-U100 and HumIns-U500, ultimately displaying significantly faster insulin absorption. Thomas Pieber, MD, discusses the implications of this finding with 

EASD 2026: EloraTZP Bests Tirzepatide on Weight Loss, A1C in Type 2 Diabetes


An investigational combination of eloralintide and tirzepatide, dubbed EloraTZP, significantly outperformed tirzepatide alone in patients with 

 or overweight and T2D. In a phase 2b trial presented at the European Association for the Study of Diabetes (EASD) 2026 Annual Meeting, EloraTZP led to substantially greater body weight and A1c reductions at 48 weeks, with all EloraTZP dose combinations meeting all primary and secondary endpoints.


Diabetes Dialogue: Weekly Insulin Efsitora Alfa Gets FDA Approval for Type 2 Diabetes

, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discuss the FDA’s approval of weekly insulin efsitora alfa. The duo expressed excitement for the new option, while also noting the potential barriers of education regarding loading doses, concentrated pen conversions, and coverage, as insulin icodec saw similar gaps following its launch earlier in 2026.


Diabetes Dialogue: Retatrutide Phase 3 Data Show Major Weight Loss


In this episode of Diabetes Dialogue, Isaacs and Bellini discuss the TRIUMPH-2 and TRIUMPH-3 trials, which examined retatrutide’s capacity to reduce weight and improve glycemic control in patients with T2D. The trials, comparing retatrutide to placebo, resulted in major weight loss efficacy data and substantial reductions in triglycerides, non-HDL-C, and systolic blood pressure. Although gastrointestinal effects were common across both trials, Isaacs and Bellini conclude that retatrutide is a significantly promising new option for weight loss, and express their anticipation for its progress through the pipeline.

Articles

Regulatory momentum in endocrinology accelerated with approvals spanning cardiorenal risk reduction, diabetes device innovation, and next-generation metabolic pharmacotherapy. Finerenone gained an expanded indication for CKD associated with type 1 diabetes, while tirzepatide secured a cardiovascular risk–reduction indication in type 2 diabetes following outcomes data versus an established comparator. The FDA also cleared a smaller, reusable insulin patch-pump platform. Late-breaking trials highlighted robust multi-comorbidity benefits with retatrutide, BMI-agnostic performance of rapid U500 insulin, and superior metabolic efficacy from eloralintide plus tirzepatide.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.

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This page also hosts content previously published by EndocrinologyNetwork. 


Type 2 Diabetes

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FDA News

8 Endocrinology Headlines You Missed in Q3 2026

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.


Telikibart (GR1802) is an investigational fully human monoclonal antibody targeting IL-4Rα, blocking IL-4 and IL-13 signaling, with an Fc region engineered to eliminate antibody-dependent cell-mediated cytotoxicity.

What did the phase 3 telikibart trial show?


In 450 adults with moderate to severe atopic dermatitis, telikibart achieved EASI-75 in 69.6% of patients versus 22.5% with placebo at week 16, and in more than 94% of patients by Week 52.

Nearly 70% of adults with moderate to severe atopic dermatitis treated with telikibart reached EASI-75 at Week 16, roughly triple the placebo rate, according to phase 3 results presented as a late-breaking abstract at the 2026 European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria. By Week 52, more than 9 in 10 patients on continuous or crossover therapy achieved this threshold.¹

Telikibart, also known as GR1802, is a fully human monoclonal antibody against the interleukin 4 receptor alpha (IL-4Rα) subunit, blocking both IL-4 and IL-13 signaling. Its Fc region carries 3 engineered mutations designed to eliminate antibody-dependent cell-mediated cytotoxicity, a modification the investigators linked to a favorable safety profile.¹

The trial was conducted across dozens of dermatology centers in China, with authors led by Shangshang Wang of Huashan Hospital, Fudan University, in Shanghai. A prior phase 2 study had shown early efficacy signals in this population.¹

How Was the Telikibart Phase 3 Trial Designed?

The randomized, placebo-controlled trial (NCT06216392) enrolled 450 adults between January 2024 and August 2025, assigning them 2:1 to telikibart (n = 299) or placebo (n = 151). Patients received a 600 mg loading dose followed by 300 mg every 2 weeks during a 16-week induction period.¹˒²

All participants then received telikibart 300 mg every 2 weeks through Week 52, with placebo recipients given a 600 mg loading dose at crossover.¹

Coprimary end points at the 16 week mark were EASI-75 and Investigator's Global Assessment (IGA) 0/1 with at least a 2-point improvement from baseline.¹

What Efficacy Did Telikibart Show at Weeks 16 and 52?

At Week 16, 69.6% of patients receiving telikibart achieved EASI-75 compared with 22.5% receiving placebo (difference, 47.1%; 95% CI, 38.62-55.50; 

 < .0001). IGA 0/1 response reached 33.1% versus 6.6% (difference, 26.5%; 95% CI, 19.86-33.15; 

Telikibart also outperformed placebo on EASI-90, a reduction of at least 4 points in weekly average Peak Pruritus Numerical Rating Scale (PP-NRS) score, and least squares mean improvement in Dermatology Life Quality Index (all 

Responses deepened during maintenance. At the 52-week mark, EASI-75 rates were 94.3% among patients treated with telikibart throughout and 95.9% among those switched from placebo. IGA 0/1 rates reached 65.4% and 58.5%, and itch improvement of at least 4 points was achieved by 76.0% and 76.7%, respectively.¹

Did Telikibart Work Across Patient Subgroups?

Prespecified subgroup analyses showed higher Week 16 EASI-75 rates with telikibart versus placebo in every subgroup assessed (all 

 < .01). This included patients previously treated with other IL-4Rα inhibitors and those with prior immunosuppressant exposure. The investigators cited these findings as further support for the consistency of telikibart's treatment effect.¹

During the 16-week double-blind period, treatment-emergent adverse events occurred in 64.5% of the telikibart group and 57.6% of the placebo group. Across the full study, 82.2% of patients receiving at least 1 dose of telikibart experienced an adverse event, most rated grade 1 or 2 by Common Terminology Criteria for Adverse Events version 5.0.¹

The abstract did not identify which adverse events were most common or report rates of serious events or discontinuations.

Week 52 results reflect open-label treatment in both groups, so they were not compared statistically, and the abstract did not describe how missing data were handled or how many patients completed the study. Because the trial enrolled only adults at centers in China, findings may not extend to adolescents or other populations.

Editor’s note: This summary has been edited for grammar and clarity using artificial intelligence tools.

Wang S, Wu L, Li Y, et al. Efficacy and safety of telikibart, a novel anti-IL-4Rα monoclonal antibody, for moderate-to-severe atopic dermatitis: 52-week outcomes and prespecified subgroup analyses from a randomized, placebo-controlled phase III trial. Abstract LB-120. Presented at: 2026 European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026; Vienna, Austria.

Telikibart (GR1802) in moderate-to-severe atopic dermatitis. ClinicalTrials.gov identifier: NCT06216392. Accessed October 3, 2026. 

https://clinicaltrials.gov/study/NCT06216392

Telikibart (GR1802), a fully human anti–IL-4Rα monoclonal antibody engineered to abrogate ADCC, demonstrated robust efficacy in moderate-to-severe adult atopic dermatitis in a China-based phase 3 trial. At Week 16, EASI-75 and IGA 0/1 responses were significantly higher versus placebo, with parallel improvements in EASI-90, pruritus, and DLQI. After crossover to open-label telikibart through Week 52, response rates deepened to >94% for EASI-75 with sustained itch control. Safety was mostly grade 1–2.

In a phase 3 study, telikibart achieved EASI-75 in 69.6% of adult patients with atopic dermatitis at Week 16, with rates above 94% by Week 52.

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.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

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

EADV 2026: Telikibart Attains EASI-75 in 70% at Week 16 in Atopic Dermatitis

Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

and immunology regulatory activity accelerated from July through September 2026. The 

 extended Ryaltris (olopatadine/mometasone) to children aged 6 to 11 years with seasonal allergic rhinitis, accepted marketing applications for lonvo-z and oral deucrictibant in hereditary angioedema (HAE), and granted Fast Track designation to Aravax's PVX108 for peanut allergy.

Aquestive resubmitted its Anaphylm New Drug Application (NDA), and a WAO Delphi panel endorsed ED05-based precautionary allergen labeling. HCPLive features examined Palforzia's discontinuation, the delayed allergic toll of wildfire smoke, and why anaphylaxis guidelines lag behind epinephrine nasal spray.

Explore this quarter's top allergy news, FDA updates, clinical trial data, and expert insights below.

FDA Ryaltris Pediatric Approval in Allergic Rhinitis

FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis

The FDA expanded the approval of Ryaltris (olopatadine hydrochloride and mometasone furoate; Glenmark Pharmaceuticals) nasal spray to include seasonal allergic rhinitis in children aged 6 to 11 years, the company announced July 21, 2026. The fixed-dose antihistamine and corticosteroid combination was first approved in 2022 for patients aged ≥ 12 years.

Approval was supported by a phase 3, randomized, double-blind, placebo-controlled trial of 446 children, in which 1 spray per nostril twice daily improved nasal symptoms vs placebo over 14 days and was well tolerated. The most common adverse reactions were dysgeusia, epistaxis, and nasal discomfort.

Lonvo-z and Deucrictibant HAE New Drug Applications Accepted by FDA

Lonvo-z BLA Accepted by FDA With Priority Review for HAE

The FDA accepted the Biologics License Application for lonvoguran ziclumeran (lonvo-z; Intellia Therapeutics) with priority review for HAE in patients aged ≥16 years, setting a PDUFA date of March 10, 2027. If approved, the one-time CRISPR/Cas9 therapy targeting KLKB1 would be the first in vivo gene-editing treatment for HAE, and the FDA does not currently plan an advisory committee.

In the phase 3 HAELO trial, a single 50 mg dose reduced mean monthly attacks by 87% vs placebo. Overall, 62% of treated patients remained attack-free and therapy-free through 6 months vs 11% with placebo, and all adverse events were mild or moderate.

What CRISPR Gene Therapy Means for HAE: FAQ on This 1-Time Treatment

FDA Accepts NDA for Oral Deucrictibant for HAE Attacks

The FDA accepted Pharvaris' NDA for deucrictibant immediate-release capsules, an oral bradykinin B2 receptor antagonist for on-demand treatment of HAE attacks, with a PDUFA date of April 23, 2027. If approved, it would become the first oral agent in its class for acute HAE attacks.

The phase 3 RAPIDe-3 trial, which enrolled patients aged ≥ 12 years, including those with normal C1 inhibitor levels, met its primary endpoint and all 11 secondary efficacy endpoints. Median time to onset of symptom relief was 1.28 hours, and median time to complete attack resolution was 11.95 hours.

Aravax's PVX108 Receives FDA Fast Track Designation for Peanut Allergy

The FDA granted Fast Track designation to PVX108 (Aravax), an investigational peptide immunotherapy for peanut allergy, on August 3, 2026. Built from 7 short synthetic fragments of the major peanut allergen, PVX108 contains no whole allergen or extract and is administered intradermally once monthly without dose escalation.

In the phase 1 AVX-001 trial of 67 peanut-allergic adults, no serious adverse events occurred, and mild injection site reactions were the only event more frequent than with placebo. Exploratory analyses showed peanut-reactive T cells shifting toward tolerance, and topline phase 2 data are expected later in 2026.

Aquestive Resubmits Anaphylm NDA for Anaphylaxis Treatment

Aquestive Therapeutics resubmitted its NDA for Anaphylm (dibutepinephrine) sublingual film, a needle-free epinephrine prodrug for type I allergic reactions including anaphylaxis, on September 17, 2026. The resubmission responds to a January 30, 2026 Complete Response Letter (CRL) requesting a packaging-focused human factors study and a confirmatory pharmacokinetic study.

Revised packaging cut median pouch-opening time from 17 seconds to 3 seconds, and no protocol-defined use errors occurred in the self-administration arm. The FDA has not yet classified the resubmission or set a review timeline.

Anaphylm Is Back at the FDA: A Clinician FAQ on Needle-Free Epinephrine

WAO Delphi Consensus on Precautionary Allergen Labeling

WAO Delphi Consensus Endorses ED05-Based Allergen Labelling

A World Allergy Organization (WAO) ACT-UP! e-Delphi panel of 35 experts across 21 countries reached consensus on 33 of 35 statements on precautionary allergen labeling. The panel recommended "may contain" warnings apply only when a mandatory risk assessment shows unintended allergen presence exceeding an action level based on ED05 reference doses, the amount estimated to trigger objective reactions in ≤5% of allergic individuals.

Panelists rejected a fixed 5 ppm cutoff, while 10 ppm failed to reach consensus. "May contain X" emerged as the preferred wording, and 97% agreed free-from labels should mean no detectable allergen.

Palforzia Discontinuation, Wildfire Smoke, and Neffy Guideline Gap

Palforzia Discontinued, Ending the Only FDA-Approved Peanut OIT Option

Palforzia (peanut [Arachis hypogaea] allergen powder-dnfp), the first and only FDA-approved oral immunotherapy (OIT) for peanut allergy, was discontinued as of July 31, 2026. Stallergenes Greer said the withdrawal was unrelated to safety, quality, or efficacy. 

 spoke to experts on what this discontinuation means for the allergy field.

How Wildfire Smoke Triggers Allergic Disease Long After It Clears

Smoke from Canadian wildfires blanketed the East Coast and Midwest in summer 2026, and emerging research suggests its allergic toll can outlast the haze. HCPLive spoke with environmental health experts on wildfire smoke’s impact on allergies.

Wildfire Smoke's Hidden Toll on Patients with Allergies

Epinephrine Nasal Spray Available, but Anaphylaxis Guidelines Lag

Epinephrine nasal spray (neffy) received FDA approval on August 9, 2024, but formal anaphylaxis practice parameters have not yet incorporated it. HCPLive spoke with allergists on how to counsel patients about epinephrine nasal spray before anaphylaxis guidelines catch up.

Regulatory momentum intensified in allergy/immunology, led by pediatric label expansion for intranasal combination therapy in allergic rhinitis and advancing HAE programs spanning one-time gene editing and first-in-class oral acute therapy. Peanut allergy development saw both disruption and acceleration, with cessation of the only FDA-approved OIT and Fast Track support for peptide-based immunotherapy. Needle-free epinephrine progressed via NDA resubmission addressing human factors and PK requirements. Global experts moved toward ED05-driven, risk-assessed precautionary allergen labeling, alongside heightened attention to wildfire smoke’s prolonged allergic sequelae.

Ryaltris pediatric approval, lonvo-z and deucrictibant HAE filings, PVX108 Fast Track, and Palforzia's exit headline Q3 2026 allergy news.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Q3 2026 Recap: Allergy News and Updates

Upadacitinib (Rinvoq) treatment at 15 mg and 30 mg produces higher placebo-adjusted response rates than nemolizumab (Nemluvio) across skin and itch treatment targets through Week 16 in adults and adolescents with moderate to severe 

 receiving background topical corticosteroids, according to a matching-adjusted indirect comparison.¹

2026 European Academy of Dermatology and Venereology (EADV) Congress

.¹ The AbbVie-funded analysis, first presented at the Revolutionizing Atopic Dermatitis (RAD) Conference in June 2026, was led by Jonathan I. Silverberg, MD, PhD, MPH, of George Washington University School of Medicine and Health Sciences. The findings were presented as Poster P1668. No head-to-head trial has compared the oral Janus kinase 1 inhibitor with the interleukin 31 receptor alpha antagonist.¹

How Did Investigators Compare Upadacitinib and Nemolizumab?

The team used individual patient data from the phase 3 AD Up trial (NCT03568318), in which patients received upadacitinib 15 mg, upadacitinib 30 mg, or placebo with topical corticosteroids for 16 weeks.¹˒² Because patient-level nemolizumab data were unavailable, investigators relied on published aggregate results from the phase 3 ARCADIA 1 and 2 trials of nemolizumab 30 mg.¹˒³

Upadacitinib patients were weighted to mirror nemolizumab trial populations on disease severity scores, age, weight, sex, race, and quality of life. All trials required an EASI score of 16 or higher, at least 10% body surface area, and a Worst Pruritus Numerical Rating Scale (WP-NRS) score of 4 or higher.¹

Outcomes followed the Aiming High in Eczema/Atopic Dermatitis (AHEAD) framework. Moderate targets included EASI-75, a WP-NRS improvement of 4 points or more, and both combined, while optimal targets were EASI-90 and a WP-NRS score below 2. Comparisons relied on placebo-adjusted risk differences with nonresponder imputation.¹

Before placebo adjustment, matching-adjusted EASI-75 rates at Week 16 were 68.3% with upadacitinib 15 mg and 79.2% with upadacitinib 30 mg, compared with 42.9% reported for nemolizumab in ARCADIA.¹

At the 16-week mark, placebo-adjusted EASI-75 response reached 40.8 percentage points with upadacitinib 15 mg and 51.8 points with upadacitinib 30 mg, compared with 13.4 points with nemolizumab. For EASI-90, the corresponding values were 33.7, 54.9, and 8.0 points.¹

Itch outcomes followed a similar pattern. Placebo-adjusted rates for a WP-NRS improvement of at least 4 points were 40.4 and 48.6 points with the 2 upadacitinib doses versus 24.0 points with nemolizumab, and rates for a WP-NRS score below 2 were 31.4 and 42.2 points versus 18.3 points.¹

For the combined skin and itch target, placebo-adjusted response was 36.2 and 48.5 points with upadacitinib versus 12.8 points with nemolizumab. Risk differences favored both upadacitinib doses across all 5 outcomes (P < .001).¹

Significant differences favoring upadacitinib appeared by Week 2 for both itch endpoints and by the fourth week for EASI-75, EASI-90, and the combined skin and itch target. These differences held at every subsequent assessment through Week 16.¹

What Limitations Should Clinicians Consider?

Patients in the ARCADIA trials could use topical calcineurin inhibitors alongside corticosteroids and completed a topical run-in period before baseline, both of which the authors acknowledged could bias results. Indirect comparisons also cannot account for unmeasured differences between trial populations.¹

The WP-NRS score below 2 endpoint was derived specifically for this analysis to match ARCADIA reporting, since AD Up originally reported WP-NRS 0/1. AbbVie funded the study, and several authors are company employees.¹

Silverberg JI, Bunick CG, Chovatiya R, et al. Comparative efficacy of upadacitinib and nemolizumab in combination with background topical therapy in adults and adolescents with moderate-to-severe atopic dermatitis: a placebo-anchored matching-adjusted indirect comparison. Poster P1668. Presented at: 2026 European Academy of Dermatology and Venereology Congress; September 30-October 3, 2026; Vienna, Austria.

Silverberg JI, et al. J Allergy Clin Immunol. 2022;143(3):977-987.

Silverberg JI, et al. Lancet. 2024;404(10451):445-460.

Upadacitinib 15 mg and 30 mg demonstrated larger placebo-adjusted improvements than nemolizumab 30 mg across AHEAD-aligned skin and pruritus targets through Week 16 in moderate-to-severe atopic dermatitis on background topical corticosteroids. Using a placebo-anchored matching-adjusted indirect comparison, upadacitinib favored nemolizumab for EASI-75/90, WP-NRS improvements, and combined skin-plus-itch response, with early separation by Week 2 for itch. Interpretation is constrained by cross-trial differences, endpoint harmonization, and sponsor involvement.

An indirect comparison finds higher placebo-adjusted skin and itch responses with upadacitinib vs nemolizumab in atopic dermatitis.

Upadacitinib Tops Nemolizumab on Skin, Itch Targets in Indirect Analysis

Pulmonology has seen significant growth over the past few months, with the acceptance of major New Drug Applications by the 

 and a series of major conferences around the world. With so much new data and so many major headlines published over the last 3 months, the 

 editorial team has compiled 8 of the most impactful stories from the third quarter of 2026. As we move into the fourth and final quarter of the year, catch up on anything you may have missed below:


FDA Accepts sBLA for Clesrovimab-cfor in Second RSV Season


On August 6, 2026, the FDA accepted a supplemental Biologics License Application for clesrovimab-cfor, an extended half-life monoclonal antibody, to expand its indication and add prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in patients ≤2 years of age at increased risk of severe RSV through their second RSV season. Announced by parent company Merck, the FDA has set a PDUFA target action date of March 22, 2027.


FDA Fast Tracks LTI-03 for Idiopathic Pulmonary Fibrosis


On August 20, the FDA granted Fast Track designation to LTI-03, an inhaled peptide therapy, for idiopathic pulmonary fibrosis (IPF). This decision followed an Orphan Drug designation already granted to LTI-03. It also came during the enrollment process for RENEW, a phase 3 trial investigating LTI-03 for changes in forced vital capacity from baseline.


FDA Updates Sotatercept Label with HYPERION Data in Early PAH


On September 22, the FDA approved a label update for sotatercept-csrk for 

. The new label includes efficacy and safety data from the phase 3 HYPERION trial, which demonstrated sotatercept’s efficacy in reducing the risk of clinical worsening events compared to placebo. While the activin signaling inhibitor already carries approval for adults with PAH to improve exercise capacity and reduce clinical worsening events, the HYPERION trial specifically targeted patients earlier in their disease course, leading to the label update.


Semaglutide Cuts Asthma Attacks by up to 40% in Real-World Study


A real-world analysis of UK electronic health records has indicated semaglutide’s association with a ≤40% reduction in 

chronic obstructive pulmonary disease (COPD)

 flare-ups compared to sulfonylureas. While prior research has indicated that GLP-1s have possible anti-inflammatory effects that may improve lung-related outcomes, the present analysis more directly addresses semaglutide’s efficacy in reducing airway exacerbations.


Verekitug's TSLP Mechanism and VALIANT Trial Results, With Michael Wechsler, MD


Upstream Bio’s investigational monoclonal antibody verekitug, developed to target the thymic stromal lymphopoietin (TSLP) receptor, met its primary endpoint of reducing annualized asthma exacerbation rates in the phase 2 VALIANT trial. In a Q&A with the 

 editorial team, Michael Wechsler, MD, MMSc, professor of medicine and director of the Cohen Family Asthma Institute at National Jewish Health, discusses the drug’s mechanism and the trial’s key safety and efficacy findings.


Zumilokibart Rapidly Suppresses FeNO in Phase 1b Asthma Data: Mario Castro, MD


Another presentation from the European Respiratory Society International Congress, this one by Mario Castro, MD, MPH, professor of medicine at the University of Kansas School of Medicine, highlighted new topline interim findings from a phase 1b trial of zumilokibart in mild to moderate asthma. The long-acting anti-interleukin-13 monoclonal antibody in development by Apogee Therapeutics demonstrated rapid and sustained suppression of fractional exhaled nitric oxide in this patient population, effectively outperforming placebo.


AI-Powered ECG and Echo Could Shrink 2.5-Year Diagnostic Delay in PH


PAH possesses an average diagnostic delay of roughly 2.5 years, due in large part to the subtlety of early symptoms and low index of suspicion across primary care and subspecialty settings. To combat this, AI-powered devices such as Mayo Clinic’s PH Early Detection Algorithm are in development to detect signals in brightness and contrast gradients of waveform data, thereby detecting signs of PAH before symptoms become apparent. In an interview with 

, Andaleeb Chowdhury, MD, assistant professor of medicine at the Lewis Katz School of Medicine at Temple University, discusses just how close these and similar models are to clinical deployment.


Closing the AATD Diagnostic Gap, With Sarah Tomashefski, MSN

Alpha-1 antitrypsin deficiency (AATD) is among the most persistently underdiagnosed genetic conditions in pulmonology, with >90% of patients with severe disease undiagnosed and delays taking roughly 8-10 years from symptoms to confirmed testing. In a Q&A with the 

 editorial team, Sarah Tomashefski, MSN, AGNP-C, lead outpatient pulmonary advanced practice provider at Prisma Health in Greenville, South Carolina, discussed where these diagnoses go missed and how clinicians can work to close this gap.

Pulmonology drug development and clinical practice are advancing rapidly, spanning pediatric RSV prevention, fibrotic lung disease, and earlier intervention in PAH. Regulatory momentum includes an expanded-season sBLA for clesrovimab and Fast Track for inhaled LTI-03 in IPF, alongside a sotatercept label update incorporating HYPERION outcomes. New evidence suggests semaglutide may reduce airway exacerbations in real-world settings, while biologics targeting TSLP receptor and IL-13 show promising asthma signals. Persistent diagnostic delays in PAH and AATD are being addressed via AI tools and improved testing pathways.

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.

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.

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.

8 Pulmonology Headlines You Missed in Q3 2026

Check out highlights from news published on Day 3 of the EADV Congress 2026, spanning psoriasis, cutaneous lupus, atopic dermatitis, and more.

EADV Congress 2026: Day 3 Recap—5 Headlines to Know

Iltefat H. Hamzavi, MD, discusses phase 3 Tranquillo data showing higher facial and total body repigmentation with ritlecitinib in vitiligo.

Vitiligo

Vitiligo condition center page is a comprehensive resource for clinical news and insights on the dermatologic condition. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for the affected skin of vitiligo patients.

Phase 3 Ritlecitinib Results in Vitiligo, With Iltefat Hamzavi, MD

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 30 days.

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.

8 Pulmonology Headlines You Missed in September 2026

Werth discusses what the 52-week AMETHYST Part A data add to the case for litifilimab in antimalarial-refractory cutaneous lupus erythematosus.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

AMETHYST: Litifilimab Sustains CLE Gains at 52 Weeks, With Victoria Werth, MD

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.

Cardiomyopathy

Dyslipidemia

9 Cardiology Headlines You Missed in Q3 2026

Mike Hess, MPH, RRT, RPFT, senior director of advocacy and regulatory affairs at the COPD Foundation.

On World Oxygen Day, the COPD Foundation's Mike Hess outlines the stigma, training gaps, and Medicare barriers affecting patients on supplemental oxygen.

Why Oxygen Stigma Persists, With Mike Hess, MPH

Mandana Khalili, MD, is Chief of Clinical Hepatology and Director of Clinical and Translational Research in Hepatology at San Francisco General Hospital, and directs the UCSF T32 Hepatology Training Program.

Drinking fell for the first time since COVID-19, but not for adults 50 to 64. Hepatologists explain what clinicians can do to close the gap.

Latest News

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Upadacitinib Tops Nemolizumab on Skin, Itch Targets in Indirect Analysis

8 Pulmonology Headlines You Missed in Q3 2026