8 Pulmonology Headlines You Missed in September 2026

September was a busy month for pulmonology, with the US Food and Drug Administration (FDA) accepting a wide range of treatments and the European Respiratory Society 2026 Congress highlighting a series of major trial readouts. As we close in on the end of the year, catch up on any major headlines you may have missed with the HCPLive team’s month in review below:

FDA News

FDA Updates Sotatercept Label with HYPERION Data in Early PAH

On September 22, the FDA approved a label update for sotatercept-csrk for pulmonary arterial hypertension (PAH). 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.

FDA Grants Priority Review for Insmed's ARIKAYCE sNDA for MAC Lung Disease

On September 21, 2026, the FDA officially granted priority review to the supplemental New Drug Application for amikacin liposome inhalation suspension to treat mycobacterium avium complex lung disease. Announced by parent company Insmed, the decision comes in response to positive data from the ENCORE trial, which demonstrated earlier, greater, and more durable culture conversion with amikacin liposome inhalation suspension versus placebo. The FDA has issued an expected PDUFA date of January 28, 2027.

FDA Accepts Nebulized Treprostinil sNDA for Idiopathic Pulmonary Fibrosis

On September 3, 2026, the FDA accepted a supplemental New Drug Application for nebulized Treprostinil Inhalation Solution to treat idiopathic pulmonary fibrosis (IPF). The submission was based on positive data from the phase 3 TETON-1 and TETON-2 trials, which demonstrated the drug’s efficacy in improving absolute forced vital capacity. The FDA’s review is expected to be complete in late April 2027.

Trial Readouts

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 asthma attacks and a 20% 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.

Tozorakimab Cuts COPD Exacerbations Across Eosinophil Levels: Frank Sciurba, MD

Full phase 3 results from the replicate OBERON and TITANIA trials have demonstrated tozorakimab’s efficacy in reducing COPD exacerbations irrespective of blood eosinophil count or smoking status. The anti-interleukin-33 monoclonal antibody, dosed every 4 weeks, successfully reduced moderate and severe exacerbations by 29% in OBERON and 34% in TITANIA among former smokers, leading the FDA to accept tozorakimab’s Biologics License Application. A PDUFA date is anticipated in the first quarter of 2027.

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 HCPLive 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.

Conference News

Oral STAT6 Degraders Fill Niche in Asthma Care, With Michael Wechsler, MD

In a presentation at the European Respiratory Society Congress 2026, Michael Wechsler, MD, MMSc, discussed the potential of oral STAT6 degraders as unique, distinct additions to the asthma pipeline. In particular, Wechsler highlighted KT-621, Kymera Therapeutics’ investigational STAT6 degrader, and its effects in patients with comorbid asthma in the phase 1b BroADen trial.

What 2 Seasons of Arexvy Data Reveal About RSV-Related Risk Reduction

Real-world data from 2 respiratory syncytial virus (RSV) seasons have indicated that adjuvanted RSVPreF3 vaccination (Arexvy) effectively reduces the risk of RSV-related cardiovascular events, severe COPD exacerbations, and severe asthma exacerbations in adults ≥60 years. Presented at the European Respiratory Society Congress 2026 by Ann Falsey, MD, professor of medicine at the University of Rochester School of Medicine, these data may help inform recommendations for revaccination timing in the future.