
8 Pulmonology Headlines you Missed in Q2 2026
Key Takeaways
- Nebulized treprostinil improved multiple phase 3 IPF endpoints, including FVC decline, composite clinical worsening, acute exacerbations, and a first-in-class DLCO improvement, enabling a planned summer 2026 sNDA.
- Tozorakimab reduced moderate-to-severe COPD exacerbations in MIRANDA, extending LUNA program consistency across smoker status, eosinophil strata, and severity, supporting anticipated regulatory submissions.
Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.
Q2 2026 was anchored by the
Conference coverage also yielded new real-world PASSAGE data on tezepelumab across underrepresented asthma populations, an ATS-presented cohort linking long-term insulin resistance to CT-quantified ILD, and a timely APAPP session on the unified airway as a framework for reducing asthma hospitalization risk.
Here's a concise overview of the key pulmonology stories from Q2 2026.
AstraZeneca announced in April that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, reducing annualized moderate-to-severe COPD exacerbation rates versus placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — when added to inhaled standard of care. The result marks the third consecutive positive phase 3 readout in the LUNA program, following OBERON and TITANIA, and extends the exacerbation reduction signal to a more frequent subcutaneous dosing regimen. The consolidating evidence base positions tozorakimab for anticipated regulatory submissions in COPD.
Related coverage:
The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older, extending a treatment paradigm previously limited to adults into adolescent patients with asthma or COPD. The approval was grounded in phase 3 KALOS and LOGOS data, published in The Lancet Respiratory Medicine, which showed a pooled 76 mL improvement in trough FEV₁ and a reduction in severe exacerbations over dual therapy. The pediatric and adolescent label expansion addresses a population that had previously been managed with separate controller agents.
Related coverage:
Nebulized treprostinil (Tyvaso; United Therapeutics) reduced FVC decline by 130.1 mL vs placebo (95% CI, 82.2 to 178.1; P <.001) and cut the risk of a composite clinical worsening endpoint — encompassing ≥10% relative FVC decline, respiratory hospitalization, and all-cause mortality — by 33% (HR, 0.67; P =.003) over 52 weeks in the phase 3 TETON-1 trial, presented at ATS 2026. In a combined analysis with TETON-2, the program met 5 of 6 secondary endpoints, including a 48% reduction in acute exacerbations (P =.0223) and the first significant DLCO improvement demonstrated by any IPF therapy in a phase 3 trial. United Therapeutics plans to submit a supplemental NDA by summer 2026 seeking priority review for the IPF indication, which would make nebulized treprostinil the first inhaled therapy approved for the condition.
Ralinepag, an investigational once-daily oral prostacyclin receptor agonist with higher potency than existing agents in this class, reduced the risk of clinical worsening in pulmonary arterial hypertension by 55% vs placebo (HR, 0.45; P <.0001) in the phase 3 ADVANCE OUTCOMES trial, presented at ATS 2026 by Vallerie McLaughlin, MD. Secondary endpoints showed significant NT-proBNP reductions, improved 6-minute walk distance, and 47% greater odds of clinical improvement. United Therapeutics has announced plans for an FDA new drug application submission in the second half of 2026.
Phase 4 PASSAGE data presented at ATS 2026 showed tezepelumab, an anti-TSLP monoclonal antibody, reduced annualized asthma exacerbation rates by 70% (95% CI, 63 to 75) in a 286-patient real-world cohort intentionally enriched for populations excluded from pivotal trials — including active smokers with ≥10 pack-years, patients with mild-to-moderate comorbid COPD, and Black or African American patients. Exacerbation reductions ranged from 54% to 77% across subgroups regardless of eosinophil count or allergic status, and clinically meaningful improvements were observed across validated asthma control and quality-of-life measures. The findings support biologic use in patients previously considered poor candidates due to smoking history or airflow obstruction.
A Multicenter AIDS Cohort Study analysis presented at ATS 2026 found that each doubling in long-term, time-weighted insulin resistance was associated with a 1.58% greater percentage of lungs with ILD features on cardiac CT (95% CI, 0.38 to 2.78), an effect driven primarily by ground glass opacity rather than established fibrosis and independent of HIV or diabetes status. Investigator Sarath Raju, MD, of Johns Hopkins University, said the predominance of ground glass over scarring may point to metabolic inflammation as an early, potentially modifiable precursor to fibrotic lung disease, with plans to validate the findings in larger population-based cohorts. The analysis raises the question of whether targeting insulin resistance before overt diabetes could have a role in lung disease prevention.
At the APAPP National Conference, Heather O'Connell, PA-C, MS, presented the unified airway concept — the principle that the nose, sinuses, and lungs function as a single inflammatory unit — and outlined how allergic rhinitis, chronic sinusitis with and without nasal polyps, and NSAID-exacerbated respiratory disease (NERD) are systematically underrecognized contributors to asthma severity and hospitalization risk. She cited data identifying rhinitis as the most prevalent risk factor for 30-day asthma readmission and noted that allergy immunotherapy has demonstrated up to 75% exacerbation reduction in seasonal allergic rhinitis, approaching biologic-level efficacy. O'Connell also recommended that clinicians proactively screen patients with severe asthma and nasal polyps for NERD, noting that reduced NSAID use means the classic aspirin-triggered reaction may never have occurred at presentation.
The American Lung Association's 27th annual State of the Air report found that 44% of Americans — approximately 152.3 million people — live in counties receiving failing grades for ozone or fine particulate matter levels, with failing ozone grades now spanning 219 counties across 36 states, the broadest distribution since 2016. The report attributed the trend in part to climate change-driven ozone formation and expanding wildfire smoke events, and identified children — particularly Hispanic and Latino children, who are approximately 3 times more likely than white children to live in a community failing all 3 pollutant grades — as the population bearing the greatest physiological burden. Pulmonologists Juanita Mora, MD, and Vin Gupta, MD, MPA, discussed clinical and advocacy implications, with Mora calling on clinicians to engage legislators on EPA funding and clean air protections.















































































