This week’s Respiratory Research update highlights regulatory approvals, late-stage clinical progress, published data, and ongoing trial momentum across COPD, RSV prevention, and pulmonary fibrosis
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🫁 Merck wins EU approval for ENFLONSIA in infant RSV prevention [1] [EU • 17 Apr 2026]
Key point: ENFLONSIA (clesrovimab, Merck) received European Commission approval to prevent RSV lower respiratory tract disease in neonates and infants during their first RSV season.
Context: The label supports a single, non-weight-based dose with protection through 5 months; approval was backed by CLEVER and interim SMART data.
Implication: May influence prescriber choice and payer reviews pending full data.
💨 AstraZeneca reports third positive Phase 3 readout for tozorakimab in COPD [2] [20 Apr 2026]
Key point: Tozorakimab (AstraZeneca, anti-IL-33 mAb) met the primary endpoint in the Phase 3 MIRANDA trial, reducing annualized moderate-to-severe COPD exacerbations.
Context: MIRANDA enrolled 1,454 patients on inhaled standard of care, testing 300 mg every 2 weeks for 52 weeks versus placebo.
Implication: May influence prescriber choice and payer reviews pending full data.
📘 Nuance publishes ENHANCE-CHINA data for Ohtuvayre in CHEST [3] [China • 20 Apr 2026]
Key point: Ohtuvayre (ensifentrine, Nuance Pharma / Verona Pharma in Greater China) showed improvements in lung function and dyspnea in Chinese adults with COPD, according to the Phase 3 ENHANCE-CHINA publication.
Context: The randomized, placebo-controlled trial enrolled 526 patients at 46 China sites and treated for 24 weeks; the NDA was submitted to China’s NMPA in December 2025.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Vicore completes Phase 2b ASPIRE enrollment for buloxibutid in IPF [4] [22 Apr 2026]
https://vicorepharma.com/mfn_news/vicore-pharma-completes-enrollment-in-the-phase-2b-aspire-trial-of-buloxibutid-in-idiopathic-pulmonary-fibrosis/
Key point: Buloxibutid (Vicore Pharma, oral AT2 receptor agonist) completed enrollment in the Phase 2b ASPIRE study in idiopathic pulmonary fibrosis.
Context: ASPIRE enrolled more than 360 patients across more than 100 sites in 14 countries; the primary endpoint is change from baseline in FVC at 52 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Calluna finishes Phase 2 AURORA enrollment for CAL101 in IPF [5] [22 Apr 2026]
Key point: CAL101 (Calluna Pharma, anti-S100A4 monoclonal antibody) completed enrollment in the global Phase 2 AURORA study for idiopathic pulmonary fibrosis.
Context: AURORA enrolled 161 patients across more than 50 sites in the US, UK, EU, Turkey, and South Korea; the primary endpoint is change from baseline in FVC after 6 months.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- COPD innovation remains active across biologics and inhaled therapies, with AstraZeneca’s tozorakimab and Nuance’s ensifentrine both advancing in distinct mechanisms [2][3].
- IPF pipelines are moving from early signal generation to larger controlled studies, with Vicore and Calluna both hitting enrollment milestones in April 2026 [4][5].
- Merck’s EU approval adds another RSV prevention option for infants, with convenience positioned around fixed dosing rather than weight-based administration [1].
- Several of these updates are operational or topline in nature, so interpretation still depends on full datasets, subgroup detail, and regulatory review [2][4][5].
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FAQ
What was approved for infant RSV prevention in Europe?
Merck’s ENFLONSIA (clesrovimab) was approved by the European Commission for prevention of RSV lower respiratory tract disease in neonates and infants during their first RSV season [1].
What did AstraZeneca report for tozorakimab in COPD?
AstraZeneca said the Phase 3 MIRANDA trial met its primary endpoint, with a statistically significant and clinically meaningful reduction in annualized moderate-to-severe COPD exacerbations. Full numerical data were not provided in the press release [2].
What is notable about Ohtuvayre in China?
Nuance Pharma reported peer-reviewed CHEST publication of Phase 3 ENHANCE-CHINA data for Ohtuvayre (ensifentrine), showing improved lung function and dyspnea in Chinese adults with COPD. The China NDA has already been submitted and accepted for review [3].
What are ASPIRE and AURORA measuring in IPF?
ASPIRE (Vicore, buloxibutid) and AURORA (Calluna, CAL101) both use forced vital capacity, FVC, as the primary efficacy measure in IPF, although treatment duration and designs differ [4][5].
When should readers expect the next IPF readouts?
Vicore expects topline ASPIRE data in mid-2027, while Calluna expects topline AURORA data in Q1 2027 [4][5].
Entities / Keywords
ENFLONSIA, clesrovimab, Merck, MSD, RSV, infant RSV prevention, CLEVER, SMART
Tozorakimab, AstraZeneca, IL-33, MIRANDA, OBERON, TITANIA, COPD biologic
Ohtuvayre, ensifentrine, Nuance Pharma, Verona Pharma, ENHANCE-CHINA, COPD, NMPA
Buloxibutid, Vicore Pharma, ASPIRE, idiopathic pulmonary fibrosis, IPF, FVC, ATRAG
CAL101, Calluna Pharma, AURORA, S100A4, idiopathic pulmonary fibrosis, IPF, FVC
