This respiratory update focuses on respiratory disease advances, including regulatory approvals, late-stage clinical and BLA milestones, early clinical dosing, and new biologic and inhaled therapies across fibrosis, asthma, and rare pulmonary conditions.
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Chapters
0:00 Introduction
0:08 FDA Approval, JASCAYD, nerandomilast, for Progressive Pulmonary Fibrosis based on FIBRONEER-ILD
0:32 GSK US Pricing and Access Agreement for Respiratory Portfolio with Direct Purchasing Platform
0:50 Savara Resubmits BLA for MOLBREEVI, inhaled molgramostim, in Autoimmune Pulmonary Alveolar Proteinosis 1:11 Japan Approval, Dupixent for Severe Pediatric Asthma ages 6–11 supported by VOYAGE and EXCURSION
1:20 FDA Accepts BLA for INO-3107 in Adult Recurrent Respiratory Papillomatosis, Standard Review, PDUFA 30 Oct 2026
1:42 Transpire Bio First in Human Dosing of Novel Inhalation Formulation for CNS Indications
2:06 Bambusa Therapeutics Doses First COPD Patient in Phase Ib Study of Bispecific BBT002 targeting IL-4Rα and IL-5 2:29 Apogee Therapeutics Interim Phase 1b Asthma Data, single 720 mg zumilokibart dose shows durable FeNO suppression
2:50 Japan Approval, Exdensur, depemokimab, for Severe Asthma and CRSwNP with twice yearly dosing
3:11 Krystal Biotech Schedules Interim CORAL-1 Update on Highest Dose Inhaled KB407 in Cystic Fibrosis
3:25 How to reach us
Transcript
Welcome to the latest edition of Respiratory Research Updates, covering recent breakthroughs in the field. Brought to you by LucidQuest.
First, the FDA approved JASCAYD, nerandomilast, for adults with progressive pulmonary fibrosis. The decision was supported by FIBRONEER-ILD, which showed a significantly smaller decline in forced vital capacity at Week 52 versus placebo, with safety broadly consistent and no Warnings and Precautions listed.
Next, GSK entered a voluntary US agreement to lower prices and expand access across its respiratory portfolio, including a direct purchasing platform that can offer up to 66 percent savings, and SAPIR support for an albuterol API reserve.
Then, Savara resubmitted the BLA for MOLBREEVI, inhaled molgramostim via the eFlow nebulizer, for autoimmune pulmonary alveolar proteinosis. Priority Review was requested, and the program holds FDA Fast Track and Breakthrough designations, plus FDA and EMA Orphan status.
In Japan, Dupixent gained approval for severe pediatric asthma ages 6 to 11, supported by VOYAGE and EXCURSION data.
The FDA accepted INOVIO’s BLA for INO-3107 for adults with recurrent respiratory papillomatosis, standard review, with a PDUFA of 30 Oct 2026 and preliminary FDA concerns about accelerated approval eligibility noted for further dialogue.
Transpire Bio completed first-in-human dosing of a novel inhalation formulation for central nervous system indications. The study evaluates pulmonary and systemic safety, tolerability, and pharmacokinetics, with an initial focus on Parkinson’s disease psychosis and other CNS conditions alongside a pulmonary pipeline.
Bambusa Therapeutics dosed the first COPD patient in a Phase Ib proof-of-concept study of the bispecific antibody BBT002, which targets IL-4Rα and IL-5. Initial data are anticipated in the second half of 2026.
Apogee Therapeutics reported an interim Phase 1b asthma signal for zumilokibart. A single 720 mg dose produced deep, durable suppression of fractional exhaled nitric oxide through 16 weeks for all patients, with acceptable safety, and some have 32 week follow up.
In Japan, Exdensur, depemokimab, was approved for severe asthma and chronic rhinosinusitis with nasal polyps, with twice yearly dosing. SWIFT reduced annualized exacerbations, and ANCHOR improved polyp score and obstruction versus placebo plus standard of care.
Krystal Biotech announced an upcoming interim update from CORAL-1 on the highest dose of inhaled KB407 in cystic fibrosis, including transduction and wild type CFTR expression.
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Why It Matters
- Infant RSV prevention access scales in Southeast Asia with a single-dose option backed by real-world data [1].
- Gene editing, epigenetic modulation, and inhaled nanoparticles diversify respiratory pipelines across AATD, PAH, and IPF [2][3][7].
- Interchangeable omalizumab biosimilar options may ease injection burden and intensify price competition in allergy and asthma [4].
- Futility governance continues to shape late-stage respiratory programs, as seen in inhaled AATD therapy [6].
- Early IPF signals, including biomarker shifts and functional trends, need confirmation in larger, longer studies [8].
🗓️ Explore weekly details and sources
📚 See the full Respiratory archive on our research hub page.
Why it matters
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Approvals in Japan and active US filings expand biologic and gene-modality options across asthma, CRSwNP, PPF, and RRP, reshaping treatment algorithms [1][4][5][9].
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Early clinical steps in inhaled and bispecific platforms diversify approaches to type 2 inflammation and CNS–pulmonary interfaces [6][7][8].
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US pricing moves from GSK may influence patient access and payer dynamics across widely used inhaled therapies [2].
FAQ
What clinical evidence supported nerandomilast’s PPF approval?
FIBRONEER-ILD showed a significantly smaller decline in FVC at Week 52 vs placebo, with overall tolerability similar to placebo in discontinuation rates (key secondary composite not statistically significant overall) [1].
How does depemokimab differ from current asthma and CRSwNP biologics in Japan?
It is positioned as an ultra-long-acting option dosed twice yearly. SWIFT reduced asthma exacerbations and ANCHOR improved CRSwNP measures vs placebo plus SOC [9].
What is INOVIO’s regulatory status for INO-3107?
FDA accepted the BLA for standard review with a PDUFA of 30 Oct 2026 and flagged preliminary concerns about accelerated-approval eligibility. The company plans to engage FDA on pathway options [5].
What pediatric population did Dupixent’s Japan approval add?
Children aged 6–11 years with severe or refractory asthma inadequately controlled on existing therapies, supported by VOYAGE and EXCURSION data sets [4].
What is Bambusa’s BBT002 targeting in COPD?
A bispecific approach to suppress IL-4/IL-13 and IL-5 pathways via IL-4Rα and IL-5, aiming for broader type 2 inflammation control across respiratory indications [7].
Entities / Keywords
Boehringer Ingelheim; JASCAYD; nerandomilast; PPF; FIBRONEER-ILD • GSK; pricing agreement; Medicaid; SAPIR; albuterol API • Savara; MOLBREEVI; molgramostim; autoimmune PAP; eFlow • Sanofi; Regeneron; Dupixent; dupilumab; pediatric asthma; VOYAGE; EXCURSION • INOVIO; INO-3107; RRP; DNA medicine; HPV-6/11 • Transpire Bio; inhalation platform; Parkinson’s disease psychosis • Bambusa Therapeutics; BBT002; IL-4Rα; IL-5; COPD; type 2 inflammation • Apogee Therapeutics; zumilokibart; APG777; IL-13; FeNO • Exdensur; depemokimab; IL-5; severe asthma; CRSwNP • Krystal Biotech; KB407; CFTR; cystic fibrosis; CORAL-1.