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🧭 Cipla USA renews COPD Foundation partnership and lung health campaigns [1] [US • 17 Nov 2025]
https://finance.yahoo.com/news/cipla-usa-strengthens-lung-leadership-133000713.html
Context: PR highlights US COPD burden and Cipla’s inhaler leadership, tying to World COPD Day activities.
Key point: Collaboration extended for a third year with awareness initiatives across employees and communities (endpoint not specified).
Implication: Access programs. May expand screening, initiation, and follow-up at scale.
🎉 Insmed’s BRINSUPRI (brensocatib) approved for NCFB, first in disease in EU [2] [EU • 18 Nov 2025]
Context: Approval follows accelerated assessment, supported by ASPEN Phase 3 and WILLOW Phase 2 data and safety summaries.
Key point: EC approved 25 mg tablets for patients 12+ with two or more exacerbations in the past year.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.
🤝 Windtree may receive license milestones as partner restarts RDS programs [3] [US • 17 Nov 2025]
Context: Global license for SURFAXIN, lyophilized lucinactant and AEROSURF, with licensee funding development and commercialization.
Key point: Agreement allows up to $78.9M in milestones plus low double-digit royalties tied to acute pulmonary development for premature infant RDS.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
🫁 ReCode opens US enrollment for Phase 2 RCT2100 plus ivacaftor in CF [4] [US • 17 Nov 2025]
Context: Multi-part, open-label study of inhaled CFTR mRNA therapy; UK and EU sites expected to enroll in Q1 2026.
Key point: Part 3 will assess safety and tolerability over six weeks in up to 12 participants receiving RCT2100 with ivacaftor.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧒 Pretomanid pediatric PK and safety interim reported at Union meeting [5] [EU • 19 Nov 2025]
Context: IMPAACT 2034 Phase 1, single dose in 28 female children with RR-TB in South Africa and Thailand; weight-based cohorts.
Key point: Adult-comparable exposures and favorable tolerability observed after a single dose, supporting progression to multidose pediatric studies.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🛌 Partners launches Free2BREATHE value-added service for youth with asthma [6] [US • 19 Nov 2025]
Context: Program across 15 North Carolina counties, delivered via Partners Health Management care managers.
Key point: Eligible members aged 0–18 can receive hypoallergenic mattress cover and pillowcases to reduce indoor allergen exposure.
Implication: Access programs. May expand screening, initiation, and follow-up at scale.
🧪 Vast Therapeutics completes Phase 1 SAD for inhaled ALX1 nitric-oxide donor [7] [US • 18 Nov 2025]
Context: 32 healthy adults, four pre-specified exposure levels, no severe or serious adverse events; MAD underway.
Key point: ALX1 was well tolerated in single-ascending-dose study, enabling progression toward bronchiectasis Phase 2 in 1H 2026.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
Why it matters
- First-in-disease approval in EU reshapes the NCFB landscape and sets up payer negotiations for 2026 access [2].
- Inhaled genetic medicine and nitric-oxide strategies extend options in CF and bronchiectasis beyond standard modulators and antibiotics [4][7].
- Pediatric RR-TB development is moving toward child-friendly regimens, addressing a long-standing treatment gap [5].
- Regional access services can improve pediatric asthma control with simple, scalable interventions [6].
- Licensing-driven development keeps neonatal RDS innovation moving without heavy balance-sheet load for the originator [3].
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FAQ
What exactly did the EU approve for bronchiectasis?
BRINSUPRI (brensocatib 25 mg) for non-cystic fibrosis bronchiectasis in patients 12+ with two or more exacerbations in the prior 12 months, following accelerated assessment by EMA [2].
Who is eligible for ReCode’s new RCT2100 cohort and what is measured?
Up to 12 people with cystic fibrosis will receive inhaled RCT2100 plus ivacaftor over six weeks. Primary endpoints are safety and tolerability, with lung function and quality of life as secondary measures [4].
What did the IMPAACT 2034 interim show for pretomanid in children?
A single dose in female children with RR-TB produced adult-comparable pharmacokinetics and was well tolerated. Male enrollment is planned in a later multidose study due to earlier pre-clinical concerns in rodents [5].
What could Windtree receive from its licensee and for which programs?
Potential milestones up to $78.9M plus low double-digit royalties for SURFAXIN, lyophilized lucinactant and AEROSURF as the licensee restarts acute pulmonary development for neonatal RDS [3].
How far along is Vast’s ALX1 program and what is its mechanism?
ALX1 is a nebulized small-molecule prodrug delivering localized nitric oxide. The Phase 1 SAD in healthy adults showed good tolerability, with MAD ongoing and a bronchiectasis Phase 2 targeted for 1H 2026 [7].
What does Partners’ Free2BREATHE provide to families?
Allergen-barrier mattress and pillow covers at no cost for eligible pediatric asthma members, aiming to reduce indoor triggers and nighttime exacerbations across Partners’ North Carolina footprint [6].
Entities / Keywords
Cipla USA; COPD Foundation; COPD awareness • Insmed; BRINSUPRI; brensocatib; non-cystic fibrosis bronchiectasis; EC approval; ASPEN; WILLOW • Windtree Therapeutics; SURFAXIN; lucinactant; AEROSURF; neonatal RDS; licensing milestones • ReCode Therapeutics; RCT2100; ivacaftor; CFTR mRNA; SORT LNP; cystic fibrosis • TB Alliance; pretomanid; IMPAACT 2034; rifampicin-resistant TB; pediatric PK • Partners Health Management; Free2BREATHE; pediatric asthma; allergen-barrier bedding • Vast Therapeutics; ALX1; inhaled nitric oxide prodrug; bronchiectasis.