8 Pulmonology Headlines You Missed in Q3 2026

Pulmonology has seen significant growth over the past few months, with the acceptance of major New Drug Applications by the US Food and Drug Administration (FDA) 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 HCPLive 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 News

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 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.

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.

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.

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.

Clinician Insights

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 HCPLive, 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 HCPLive 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.