This week’s respiratory update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.
In Today’s Newsletter
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💊 Ritedose expands US nebulized drug line with generic Tobramycin [1] [US • 30 Oct 2025]
https://www.globenewswire.com/news-release/2025/10/30/3177385/0/en/Ritedose-Now-Offers-the-Largest-Nebulized-Drug-Portfolio-in-the-U-S-FDA-Approves-the-Company-to-Manufacture-Generic-Tobramycin-Inhalation-Solution.html
Context: FDA approval enables Ritedose to manufacture Tobramycin inhalation solution (300 mg/5 mL ampules) for cystic fibrosis.
Key point: Marks its first CF antibiotic and completes its range of nebulized generics, licensed from Hikma.
Implication: Introduces competition that may affect pricing and formulary access.
🧬 Calluna Pharma receives FDA Orphan Drug Designation for CAL101 in IPF [2] [US • 31 Oct 2025]
https://www.callunapharma.com/calluna-pharma-announces-u-s-fda-orphan-drug-designation-granted-to-cal101-for-the-treatment-of-idiopathic-pulmonary-fibrosis-ipf/
Context: CAL101 is a monoclonal antibody targeting S100A4; ongoing Phase 2 AURORA study enrolling 150 patients globally.
Key point: Orphan status provides potential tax credits, fee waivers, and market exclusivity.
Implication: May influence prescriber choice and payer reviews pending full data.
🌬 Rein Therapeutics cleared to resume US Phase 2 IPF trial of LTI-03 [3] [US • 03 Nov 2025]
https://ir.reintx.com/news-releases/news-release-details/rein-therapeutics-receives-fda-clearance-resume-us-phase-2-trial
Context: FDA lifted full clinical hold after complete response review; enrollment to restart across 20 US sites.
Key point: LTI-03 is an inhaled peptide derived from Caveolin-1 biology aimed at slowing fibrosis and supporting lung repair.
Implication: May influence prescriber choice and payer reviews pending full data.
🌐 Endeavor BioMedicines gains EMA PRIME status for taladegib (ENV-101) in IPF [4] [EU • 03 Nov 2025]
https://endeavorbiomedicines.com/endeavor-biomedicines-receives-priority-medicines-prime-designation-from-the-european-medicines-agency-for-taladegib-env-101-for-the-treatment-of-idiopathic-pulmonary-fibrosis/
Context: PRIME designation follows positive Phase 2a results showing improved lung function and reversal of fibrosis.
Key point: First and only IPF therapy with PRIME status; ongoing Phase 2b WHISTLE-PF trial.
Implication: May influence prescriber choice and payer reviews pending full data.
🔬 EpiEndo highlights epithelial defence role in COPD in Frontiers in Allergy [5] [EU • 30 Oct 2025]
https://www.epiendo.com/en/news-events/importance-of-airway-epithelium-in-lung-function-highlighted-in-article-in-peer-reviewed-journal-frontiers-in-allergy
Context: Review co-authored by EpiEndo scientists links epithelial alarmins and surfactant proteins to host immune defence.
Key point: Supports mechanism of glasmacinal, EpiEndo’s lead oral macrolide for COPD with reduced AMR potential.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🇰🇷 Hanmi to distribute Boehringer’s COPD inhalers in Korea [6] [KR • 04 Nov 2025]
https://www.koreabiomed.com/news/articleViewAmp.html?idxno=29499
Context: Deal covers Spiriva Handihaler, Spiriva Respimat, and Vahelva Respimat; sales expected to begin shortly.
Key point: 2024 Korean outpatient sales estimated at ₩21.4B combined.
Implication: Introduces competition that may affect pricing and formulary access.
🧫 Chiesi ends tanimilast COPD/asthma program after Phase 3 miss [7] [EU • 03 Nov 2025]
http://chiesi.com/en/tanimilast-program-discontinuation/
Context: Phase 3 PILASTER study failed to meet primary and key secondary endpoints; safety acceptable.
Key point: All tanimilast trials to conclude following comprehensive review.
Implication: May influence prescriber choice and payer reviews pending full data.
💉 INOVIO completes BLA for INO-3107 in recurrent respiratory papillomatosis [8] [US • 03 Nov 2025]
https://ir.inovio.com/news-releases/news-releases-details/2025/INOVIO-Completes-Rolling-BLA-Submission-Seeking-Accelerated-Approval-for-INO-3107-as-a-Treatment-for-RRP-in-Adults/default.aspx
Context: DNA immunotherapy targeting HPV-6/11; submitted under FDA accelerated approval with priority review requested.
Key point: Phase 1/2 data showed durable T cell responses and surgery reduction in adults with RRP.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Regulatory activity signals growing innovation in IPF and respiratory rare disease spaces.
- EMA PRIME and FDA Orphan/Accelerated pathways reflect agency alignment on unmet-need indications.
- Epithelial biology is emerging as a central axis in COPD and fibrosis research.
- Generic and commercial partnerships (Ritedose, Hanmi) indicate continuing market consolidation and local access strategies.
- Discontinuations like Chiesi’s tanimilast reinforce the high attrition in late-stage COPD pipelines.
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FAQ
What does FDA Orphan Drug Designation mean for Calluna’s CAL101?
It grants development incentives such as tax credits, fee waivers, and seven years of exclusivity if approved [2].
How does Rein’s LTI-03 differ mechanistically from current IPF therapies?
LTI-03 is an inhaled peptide targeting Caveolin-1 biology to both inhibit fibrosis and promote lung repair, unlike small-molecule antifibrotics [3].
Why is Endeavor’s PRIME designation significant?
It is the first IPF program to receive EMA PRIME status, providing early scientific support and faster evaluation [4].
What underpins EpiEndo’s glasmacinal approach?
It targets epithelial barrier repair and surfactant protein activation to reduce COPD exacerbations [5].
What happens after INOVIO’s BLA filing for INO-3107?
If accepted, the FDA may complete priority review by mid-2026; it could become the first DNA medicine approved in the US [8].
Why did Chiesi terminate the tanimilast program?
The Phase 3 PILASTER trial failed efficacy endpoints despite no safety issues [7].
Entities / Keywords
Ritedose • Tobramycin • Hikma • Calluna Pharma • CAL101 • S100A4 • Rein Therapeutics • LTI-03 • Endeavor BioMedicines • taladegib • IPF • EpiEndo • glasmacinal • Hanmi Pharmaceutical • Boehringer Ingelheim • Spiriva • Vahelva • Chiesi • tanimilast • INOVIO • INO-3107 • RRP
References
- https://www.globenewswire.com/news-release/2025/10/30/3177385/0/en/Ritedose-Now-Offers-the-Largest-Nebulized-Drug-Portfolio-in-the-U-S-FDA-Approves-the-Company-to-Manufacture-Generic-Tobramycin-Inhalation-Solution.html
- https://www.callunapharma.com/calluna-pharma-announces-u-s-fda-orphan-drug-designation-granted-to-cal101-for-the-treatment-of-idiopathic-pulmonary-fibrosis-ipf/
- https://ir.reintx.com/news-releases/news-release-details/rein-therapeutics-receives-fda-clearance-resume-us-phase-2-trial
- https://endeavorbiomedicines.com/endeavor-biomedicines-receives-priority-medicines-prime-designation-from-the-european-medicines-agency-for-taladegib-env-101-for-the-treatment-of-idiopathic-pulmonary-fibrosis/
- https://www.epiendo.com/en/news-events/importance-of-airway-epithelium-in-lung-function-highlighted-in-article-in-peer-reviewed-journal-frontiers-in-allergy
- https://www.koreabiomed.com/news/articleViewAmp.html?idxno=29499
- http://chiesi.com/en/tanimilast-program-discontinuation/
- https://ir.inovio.com/news-releases/news-releases-details/2025/INOVIO-Completes-Rolling-BLA-Submission-Seeking-Accelerated-Approval-for-INO-3107-as-a-Treatment-for-RRP-in-Adults/default.aspx