5 Pulmonology Headlines You Missed in June 2026

The June 2026 pulmonology month largely tracked new conversations and data from the 2026 American Thoracic Society (ATS) International Conference and the Association of Pulmonary Advanced Practice Providers (APAPP) National Conference, covering severe asthma, interstitial lung disease, and airway-disease management, alongside a long-anticipated regulatory decision in smoking cessation. In severe asthma, expanded phase 4 PASSAGE data presented at ATS showed that tezepelumab reduced annualized exacerbation rates by 70% (95% CI, 63 to 75) in a real-world cohort intentionally enriched for patients underrepresented in pivotal trials, including those with comorbid COPD, current or former smokers, and Black or African American patients, with consistent benefit across phenotypes and meaningful gains in lung function and quality-of-life measures. A separate ATS analysis drawn from the Multicenter AIDS Cohort Study linked long-term insulin resistance to quantitative increases in interstitial lung disease on CT, with each doubling in time-weighted insulin resistance associated with a 1.58% greater percentage of lung involvement, an effect driven primarily by ground glass opacity rather than established fibrosis and independent of HIV or diabetes status.

Ahead of a June 20, 2026, FDA decision date, David Hill, MD, of Waterbury Pulmonary Associates and chair of the American Lung Association National Board, had described cytisinicline as a potentially meaningful addition to a smoking cessation landscape unchanged since varenicline's 2006 approval, citing quit rates 3- to 4-fold higher than unassisted cessation and decades of real-world cytisine experience abroad. The agency did issue an expected Complete Response Letter citing manufacturing-related observations at a third-party facility and incomplete labeling, with no clinical efficacy or safety concerns identified; Achieve Life Sciences had already secured a new manufacturing partner and plans to resubmit in the fourth quarter of 2026. Elsewhere, a session at APAPP on the unified airway concept argued that allergic rhinitis, chronic sinusitis, and NSAID-exacerbated respiratory disease are underrecognized drivers of asthma burden, with rhinitis identified as the leading risk factor for 30-day readmission after asthma hospitalization and allergy immunotherapy highlighted as an intervention capable of reducing exacerbations by up to 75% in some studies.

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

FDA Issues CRL for Cytisinicline NDA in Smoking Cessation

Achieve Life Sciences announced June 22, 2026, that the FDA issued a Complete Response Letter for cytisinicline, an investigational nicotinic receptor-binding alkaloid submitted as a smoking cessation pharmacotherapy, citing manufacturing-related observations from an inspection of a third-party facility and incomplete final product labeling rather than clinical deficiencies. The application was supported by phase 3 ORCA-2 and ORCA-3 trial data showing significantly greater smoking abstinence with cytisinicline vs placebo through 24 weeks, alongside safety data from more than 1500 clinical trial participants. Achieve has partnered with Adare Pharma Solutions as a new manufacturing partner and plans to resubmit the NDA in the fourth quarter of 2026, with potential approval in the first half of 2027.

Insulin Resistance Linked to Interstitial Lung Disease on CT Measures

In a Multicenter AIDS Cohort Study analysis of 517 men presented at ATS 2026, each doubling in long-term, time-weighted insulin resistance was associated with a 1.58% greater percentage of lungs with interstitial lung disease features on CT (95% CI, 0.38 to 2.78), an association driven primarily by ground glass opacity rather than fibrosis and unaffected by HIV or diabetes status. Investigator Sarath Raju, MD, of Johns Hopkins University, said the predominance of ground glass over established scarring may point to metabolic inflammation as an early, modifiable precursor to fibrotic lung disease. The findings suggest a potential role for targeting insulin resistance before the onset of overt diabetes as a lung disease prevention strategy, pending validation in larger cohorts.

Tezepelumab Reduces Severe Asthma Exacerbations in Phase 4 PASSAGE

Phase 4 PASSAGE data presented at ATS 2026 showed that tezepelumab reduced annualized asthma exacerbation rates by 70% (95% CI, 63 to 75) in a 286-patient real-world cohort intentionally designed to reflect populations underrepresented in randomized trials, including patients with comorbid COPD, current or former smokers, and Black or African American patients. Njira Lucia Lugogo, MD, of the University of Michigan, told HCPLive that the consistency of benefit across phenotypes — alongside improvements in lung function and patient-reported outcomes — should give clinicians confidence to expand biologic use in broader, more representative patient populations. Serious adverse events occurred in 9.8% of patients, consistent with tezepelumab's established safety profile.

Unified Airway Practice: Rhinitis, Nasal Polyps, and NERD as Drivers of Asthma Burden

At the APAPP National Conference, Heather O'Connell, PA-C, MS, of Arizona Asthma and Allergy Institute, outlined the unified airway concept, under which allergic rhinitis, chronic sinusitis, and asthma represent a single inflammatory process rather than separate diseases requiring siloed management. She cited data identifying allergic rhinitis as the most prevalent risk factor for 30-day readmission following asthma hospitalization and noted that allergy immunotherapy has shown up to a 75% reduction in exacerbations in some studies. O'Connell also highlighted NSAID-exacerbated respiratory disease as a frequently missed diagnosis given declining NSAID use, recommending clinicians proactively screen patients with severe asthma and nasal polyps for a temporal link between exacerbations and NSAID exposure.

Anticipating Cytisinicline: First New Smoking Cessation Aid in Over 20 Years

Ahead of the FDA's June 20, 2026, decision date, David Hill, MD, of Waterbury Pulmonary Associates and chair of the American Lung Association National Board, discussed cytisinicline's potential as the first new smoking cessation pharmacotherapy approved since varenicline in 2006. Hill noted quit rates in the 15% to 20% range — a 3- to 4-fold improvement over the roughly 5% sustained abstinence seen with unassisted cessation — and pointed to decades of real-world experience with the structurally related compound cytisine across Eastern Europe and approximately 30 other countries as added reassurance. He also highlighted cytisinicline's Breakthrough Therapy designation for vaping cessation, an indication with no currently approved pharmacotherapy, and emphasized that any pharmacologic quit attempt should be paired with counseling and structured behavioral support.