Q1 2025 Recap: Pulmonology News and Updates

Pulmonology continues to evolve rapidly, driven by innovation in rare disease treatment, inhaled therapies, and personalized approaches to respiratory care. In the past few months, progress has extended across high-burden conditions like COPD and asthma, with new candidates showing promise where options have long been limited.

Q1 2025 was no different—signaling new milestones in drug development, regulatory movement, and clinical insights. From priority reviews and IND clearances to data readouts and expert commentary, the field has gained momentum in treating complex pulmonary conditions. To celebrate the end of Q1 2025, HCPLive Pulmonology has created a recap of the news and updates capturing headlines during the first 3 months.

In our recap, we spotlight 5 regulatory updates from the US Food and Drug Administration (FDA) and other government entities, our 5 most popular trial announcement articles, and 3 key insights from top experts featured within our coverage.

Q1 2025 Regulatory Updates in Pulmonology

Brensocatib, Potential First Treatment for Non-CF Bronchiectasis, Gets Priority Review

On February 6, the FDA granted Priority Review to Insmed’s NDA for brensocatib, a dipeptidyl peptidase 1 (DPP1) inhibitor that could be the first treatment option for patients with non-cystic fibrosis bronchiectasis. Targeting a PDUFA date of August 12, 2025, the NDA submission was based on positive data from the landmark Phase 3 ASPEN study, in which brensocatib significantly reduced the annualized rate of pulmonary exacerbations compared with placebo.

FDA Accepts BLA for PRGN-2012 for Recurrent Respiratory Papillomatosis

On February 25, the FDA accepted Precigen, Inc.’s BLA for PRGN-2012 (zopapogene imadenovec), an investigational gene therapy targeted for adults with recurrent respiratory papillomatosis (RRP), a rare disease that requires repeated surgeries with no current therapeutic alternative. A Prescription Drug User Fee Act (PDUFA) action date of August 27, 2025, was set, with no plans to hold an advisory committee meeting.

FDA Clears IND for Frevecitinib Asthma Inhaler

On January 29, the FDA has cleared Kinaset Therapeutics’ investigational new drug (IND) clearance for frevecitinib (KN-002), a novel inhaled dry powder therapeutic in development for patients with asthma that remains inadequately controlled by standard of care inhaled maintenance therapies.

FDA Accepts Treprostinil Resubmission for PAH, PH-ILD Final Approval
On March 28, the FDA accepted Liquidia Corporation’s resubmission for treprostinil inhalation powder (YUTREPIA) for pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD), positioning it for final approval after the expiration of Tyvaso DPI’s market exclusivity in May 2025. The decision marks a significant regulatory step toward expanding treatment options for these progressive and life-threatening conditions.

HHS Targets 15 Drugs for Medicare Part D Negotiations, Including Semaglutide
On January 17, the US Department of Health and Human Services (HHS), through the Centers for Medicare and Medicaid Services (CMS), announced an additional 15 drugs covered under Medicare Part D for price negotiations in 2025, targeted for chronic conditions including type 2 diabetes, COPD, and schizophrenia. Drugs to be negotiated include fluticasone furoate, umeclidinium, and vilanterol inhalation powder (Trelegy Ellipta) for COPD and fluticasone furoate / Vilanterol (Breo Ellipta) for COPD and Asthma.

Q1 2025 Trial Announcements in Pulmonology

Merck Halts Phase 3 HYPERION Trial of Sotatercept for Final Analysis

On January 30, Merck halted the Phase 3 HYPERION trial evaluating sotatercept-csrk (WINREVAIR) versus placebo in adults with recently diagnosed PAH and plans to proceed with the final analysis.Merck indicated the decision to stop HYPERION before its scheduled end date was based on positive data from the interim analysis of ZENITH and an overall review of data from the sotatercept clinical trial program.

Tezepelumab Fails Study Endpoint of Reducing Moderate-to-Severe COPD Exacerbations

Tezepelumab was not seen to reduce the annualized rate of moderate or severe COPD exacerbations, thus failing the primary endpoint of COURSE, a phase 2a trial (NCT04039113). Singh and colleagues found that the annualized rate of moderate or severe COPD exacerbations represented a nonsignificant change and thus did not meet the trial’s primary endpoint.

Dupilumab Reduced COPD Exacerbations Compared to Placebo

Adding dupilumab to standard triple therapy reduced the annualized moderate or severe exacerbations of chronic obstructive pulmonary disease (COPD) in a pooled analysis of Phase 3 findings. Moderate or severe exacerbations were reported in 36.0% of the dupilumab cohort and 42.1% of the placebo group—the dupilumab cohort also had a lower annualized exacerbation rate and longer time to first severe exacerbation than the placebo group.

Nerandomilast Meets Primary Endpoint in Improving FVC in Progressive Pulmonary Fibrosis

Nerandomilast met the primary endpoint in the Phase 3 FIBRONEER-ILD trial, significantly improving forced vital capacity (FVC) among individuals with progressive pulmonary fibrosis (PPF), compared with placebo. Based on these findings, Boehringer Ingelheim announced plans to submit an NDA for nerandomilast to the FDA.

Dupilumab Improves Small Airway Dysfunction in People With Type 2 Asthma

Dupilumab improved small airway dysfunction (SAD) among a population with type 2 high moderate-to-severe asthma, which could explain improvements in disease control, according to a post hoc analysis of the Phase 4 VESTIGE study presented at the 2025 AAAAI/WAO Joint Congress. Those treated with dupilumab reported significant improvements in SAD as measured by peripheral airway resistance and compliance.

Q1 2025 Expert Perspectives in Pulmonology

Investigating Brensocatib for Bronchiectasis – James Chalmers, MBChB, PhD – Chalmers discusses the promising role of brensocatib, a DPP1 inhibitor, as a potential first approved pharmacologic treatment for bronchiectasis following its successful Phase 3 ASPEN trial. He highlights its ability to reduce neutrophilic inflammation and exacerbations, marking a pivotal advancement in care for this underserved population.

Pollution and Asthma Morbidity in Communities of Color – Sarah Chambliss, PhD – Chambliss emphasizes the disproportionate impact of industrial pollution on asthma morbidity in communities of color, particularly due to proximity to emission sources. He advocates for targeted environmental policy and community-specific interventions to address these longstanding health disparities.

Wildfire Cleanup and Air Quality Risks – Afif El-Hasan, MD – El-Hasan addresses the overlooked respiratory hazards associated with wildfire cleanup efforts, including re-aerosolized particles and persistent indoor air contamination. He underscores the need for public health guidance to mitigate long-term respiratory risks during recovery phases.