5 Pulmonology Headlines You Missed in April 2026

April 2026 was a consequential month for pulmonology, defined above all by the continued consolidation of tozorakimab's phase 3 program and a regulatory milestone that reshapes the inhaled therapy landscape in asthma. AstraZeneca's IL-33 inhibitor added a third positive pivotal trial to its LUNA program with the MIRANDA readout, which tested the drug on a more frequent 2-week dosing interval and extended the exacerbation reduction signal to former and current smokers alike, regardless of eosinophil level or lung function severity — a population breadth that separates it mechanistically from the type 2–restricted biologics that currently dominate chronic obstructive pulmonary disease (COPD) prescribing. LUNA program chief investigator Frank Sciurba, MD, joined HCPLive to contextualize the results and explain why the IL-33 pathway's dual-form inhibition may address COPD drivers that prior biologics cannot reach.

On the asthma side, the month closed with the FDA approval of budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older — a decision grounded in the 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 approval arrives alongside growing pipeline momentum: Sanofi's bispecific lunsekimig, targeting both TSLP and IL-13, posted positive phase 2 results across asthma and chronic rhinosinusitis with nasal polyps earlier in the month, though a concurrent atopic dermatitis study missed its primary endpoint — a mixed but directionally encouraging readout for a mechanism that could eventually offer a single-agent alternative to sequential biologic escalation.

Check out this April 2026 pulmonology month in review for a recap of HCPLive's coverage of the top news and research from the past few weeks:

New Approval in Asthma

FDA Approves BGF Triple Therapy for Asthma in Patients 12 and Older

The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) on April 28 as the first single-inhaler fixed-dose triple-combination maintenance therapy for asthma in patients aged 12 years and older, marking the drug's second approved indication following its 2020 clearance for COPD. The approval was supported by the phase 3 KALOS and LOGOS trials, in which BGF demonstrated statistically significant improvements in trough FEV₁ and FEV₁ AUC₀₋₃ over dual ICS/LABA therapy at 24 weeks, along with reductions in severe exacerbation rates.

Pivotal Data Readouts

Lunsekimig Meets End Points in Asthma and CRSwNP, Misses in Atopic Dermatitis

Sanofi's lunsekimig, a bispecific Nanobody construct targeting both TSLP and IL-13, met its primary and key secondary endpoints in the phase 2b AIRCULES trial in moderate-to-severe asthma and in the phase 2a DUET trial in chronic rhinosinusitis with nasal polyps, though it did not meet its primary endpoint in the exploratory phase 2b VELVET study in atopic dermatitis. Full efficacy data from all 3 studies have not yet been disclosed, and Sanofi has characterized respiratory indications as the primary development focus, with 2 phase 3 COPD trials and a high-risk asthma study currently underway.

BGF Triple Therapy Improves Lung Function in Phase 3 Uncontrolled Asthma Controls

Full results from the phase 3 KALOS and LOGOS trials, published in The Lancet Respiratory Medicine, showed that BGF 320/28.8/9.6 µg improved trough FEV₁ by a pooled least squares mean of 76 mL (95% CI, 57–94 mL; P <.001) and FEV₁ AUC₀₋₃ by 90 mL over dual ICS/LABA at 24 weeks in patients with asthma inadequately controlled on medium- or high-dose ICS/LABA therapy. Benefits in lung function and severe exacerbation reduction were observed regardless of prior exacerbation history across the approximately 4,300 randomized patients, supporting BGF as a viable escalation option before or independent of a preceding acute episode.

Phase 3 MIRANDA: Tozorakimab Reduces COPD Exacerbations

AstraZeneca announced April 20 that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, reducing the annualized rate of moderate-to-severe COPD exacerbations compared with placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — with patients receiving 300 mg subcutaneously every 2 weeks on top of inhaled standard of care. The result marks the third consecutive positive phase 3 readout in the LUNA program, extending the exacerbation reduction signal from OBERON and TITANIA to a more frequent dosing regimen and further consolidating the evidence base ahead of anticipated regulatory submissions.

Reducing COPD Exacerbations With Tozorakimab, With Frank Sciurba, MD

Frank Sciurba, MD, professor of Pulmonary and Critical Care Medicine at the University of Pittsburgh and chief investigator of the LUNA program, discussed the clinical significance of tozorakimab's positive phase 3 program, explaining that the IL-33 inhibitor's unique ability to block both the reduced and oxidized forms of IL-33 positions it to address type 1, 2, and non-type 2 inflammatory pathways simultaneously — a mechanistic distinction from existing COPD biologics that require eosinophilic phenotyping. Sciurba noted that up to half of patients with COPD continue to experience exacerbations on standard inhaled therapy, underscoring the magnitude of the unmet need that a biomarker-agnostic agent could begin to address pending regulatory review.