This week’s Respiratory update summarizes key developments in regulatory actions, clinical progress, data releases, and partnerships. The following highlights reflect significant milestones and advancements in the field.
In Today’s Newsletter
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🍼 Eradivir nominates EV148 for RSV treatment [1] [12 Feb 2026]
https://eradivir.com/wp-content/uploads/2026-02-12-Eradivir-RSV-Candidate.pdf
Context: EV148 has been nominated as a treatment candidate for Respiratory Syncytial Virus (RSV). The drug is expected to enter clinical trials in 2026.
Key point: EV148 significantly reduced viral loads in preclinical studies by >99%.
Implication: EV148 could become a breakthrough treatment for RSV, filling a major gap in available therapies.
💊 ArkBio’s AK3280 receives FDA IND clearance [2] [12 Feb 2026]
https://arkbiosciences.com/80/115
Context: FDA has cleared ArkBio’s IND for AK3280, a novel anti-fibrotic agent for treating idiopathic pulmonary fibrosis (IPF).
Key point: AK3280 showed promising results in a Phase 2 PoC study with a favorable safety profile.
Implication: AK3280 could offer a new treatment option for IPF patients, an underserved group with limited treatment options.
💊 Serac Healthcare’s 99mTc-maraciclatide granted FDA Fast Track Designation [3] [12 Feb 2026]
https://www.prnewswire.com/news-releases/99mtc-maraciclatide-granted-fda-fast-track-designation-for-the-visualization-of-inflammation-in-interstitial-lung-disease-302686272.html
Context: 99mTc-maraciclatide, a diagnostic tool for visualizing inflammation in ILD patients, has received FDA Fast Track Designation.
Key point: Fast Track status accelerates the development and review process, which could lead to quicker access for patients.
Implication: This designation may improve diagnostic capabilities for ILD, aiding in early intervention and better treatment outcomes.
💊 Akeso’s AK139 cleared for Phase II studies [4] [13 Feb 2025]
https://www.akesobio.com/en/media/akeso-news/250214/
Context: Akeso’s AK139, a bispecific antibody targeting IL-4Rα and ST2, has been cleared by China’s NMPA to begin Phase II trials.
Key point: AK139 targets key inflammatory pathways in diseases like asthma and dermatitis.
Implication: AK139 could provide a novel approach to treating type 2 inflammatory diseases, expanding therapeutic options.
💊 AstraZeneca’s Breztri shows Phase III success in asthma [5] [13 Feb 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/positive-and-clinically-meaningful-results-from-the-phase-iii-kalos-and-logos-trials-for-breztri.html
Context: AstraZeneca announced positive Phase III results for Breztri Aerosphere in uncontrolled asthma patients.
Key point: Breztri showed statistically significant improvements in lung function and reduced asthma exacerbations compared to dual therapies.
Implication: Breztri may become a leading treatment for patients with uncontrolled asthma, offering improved clinical outcomes.
💊 Sanofi’s Beyfortus shows long-term protection against RSV [6] [16 Feb 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-16-06-00-00-3238527
Context: A study published in The Lancet Infectious Diseases found Beyfortus provides long-term protection against RSV-related hospitalizations in infants beyond the first season.
Key point: Beyfortus reduced RSV-related hospitalizations by 85.9% in the first season and 55.3% in the second.
Implication: Beyfortus may offer long-term protection against RSV, reducing hospitalizations and healthcare costs in infants.
💊 Essential Pharma acquires Ventavis for pulmonary hypertension [7] [17 Feb 2026]
https://essentialpharmagroup.com/essential-pharma-strengthens-rare-disease-portfolio-with-acquisition-of-ventavis-iloprost-trometamol-for-adult-primary-pulmonary-hypertension/
Context: Essential Pharma acquired Ventavis® (iloprost trometamol), a treatment for pulmonary arterial hypertension (PAH).
Key point: Ventavis® improves blood flow and reduces strain on the heart in PAH patients.
Implication: This acquisition expands Essential Pharma’s rare disease portfolio and provides a critical treatment option for PAH patients.
💊 GSK’s Arexvy reduces RSV-related risks [8] [17 Feb 2026]
https://www.gsk.com/en-gb/media/press-releases/gsk-s-arexvy-associated-with-reductions-in-certain-rsv-related-risks-including-heart-attack-stroke-and-severe-flare-ups-of-copd-and-asthma-real-world-study-shows/
Context: GSK’s Arexvy vaccine has shown effectiveness in reducing RSV-related hospitalizations and exacerbations in adults aged ≥60 years.
Key point: Arexvy demonstrated a 75.6% vaccine effectiveness against RSV-related hospitalizations and reductions in cardiovascular events and respiratory flare-ups.
Implication: Arexvy may be an essential tool in preventing RSV-related complications, especially in older adults with underlying conditions.
💊 Exdensur approved for severe asthma and CRSwNP in Europe [9] [17 Feb 2026]
https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-the-european-commission/
Context: Exdensur (depemokimab) has been approved by the European Commission for treating severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).
Key point: Exdensur offers twice-yearly dosing, improving convenience and patient adherence.
Implication: This approval could change the treatment landscape for severe asthma and CRSwNP, providing long-term relief with fewer doses.
💊 Boehringer halts cystic fibrosis inhaled gene therapy [10] [17 Feb 2026]
https://www.fiercebiotech.com/biotech/boehringer-axes-inhaled-gene-therapy-after-viewing-cystic-fibrosis-data
Context: Boehringer Ingelheim has discontinued its Phase 1/2 trial for a cystic fibrosis inhaled gene therapy, after the data failed to support further development.
Key point: The therapy did not meet efficacy endpoints despite showing a safety profile consistent with expectations.
Implication: This discontinuation highlights the challenges of gene therapy development for complex diseases like cystic fibrosis.
💊 Zydus receives USFDA approval for Bosentan oral suspension [11] [18 Feb 2026]
https://zyduslife.com/investor/admin/uploads/21/83/Zydus-receives-final-approval-from-USFDA-for-Bosentan-tablets-for-oral-suspension–32-mg.pdf
Context: Zydus received USFDA approval for Bosentan 32 mg tablets, an oral suspension for treating pediatric pulmonary arterial hypertension (PAH).
Key point: Bosentan helps improve exercise ability and reduce clinical worsening in children with idiopathic or congenital PAH.
Implication: This approval provides a vital treatment option for children with PAH, a rare and life-threatening condition.
Why it matters
- EV148 may provide a new treatment option for RSV, filling a critical gap in existing therapies.
- AK3280 could offer a promising new approach to treating IPF, with a safer and more effective profile compared to current therapies.
- 99mTc-maraciclatide’s Fast Track Designation may improve early diagnosis for ILD, aiding in better patient outcomes.
- Arexvy and Beyfortus present key prevention strategies against RSV-related complications, particularly in at-risk populations like the elderly and infants.
- Exdensur provides a long-acting treatment option for severe asthma and CRSwNP, requiring fewer doses than existing therapies.
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FAQ
What does Eradivir’s EV148 offer for RSV?
EV148 recruits the immune system to clear RSV infections, offering a new approach to RSV treatment.
How does ArkBio’s AK3280 benefit IPF patients?
AK3280 targets fibrosis in IPF, providing a potential new treatment with a favorable safety profile.
What does 99mTc-maraciclatide’s Fast Track Designation mean?
It accelerates the development and review process, enabling quicker access to this diagnostic tool for ILD.
How does Arexvy protect older adults from RSV?
Arexvy reduces RSV-related hospitalizations, cardiovascular events, and respiratory flare-ups in older adults.
Entities / Keywords
Eradivir, EV148, Respiratory Syncytial Virus, AK3280, Interstitial Pulmonary Fibrosis, 99mTc-maraciclatide, Fast Track Designation, AK139, IL-4Rα, ST2, Breztri, RSV, Beyfortus, Ventavis, GSK, Exdensur, Pulmonary Arterial Hypertension, Zydus, Bosentan, Cystic Fibrosis, Boehringer Ingelheim.
References
- https://eradivir.com/wp-content/uploads/2026-02-12-Eradivir-RSV-Candidate.pdf
- https://arkbiosciences.com/80/115
- https://www.prnewswire.com/news-releases/99mtc-maraciclatide-granted-fda-fast-track-designation-for-the-visualization-of-inflammation-in-interstitial-lung-disease-302686272.html
- https://www.akesobio.com/en/media/akeso-news/250214/
- https://www.astrazeneca.com/media-centre/press-releases/2026/positive-and-clinically-meaningful-results-from-the-phase-iii-kalos-and-logos-trials-for-breztri.html
- https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-16-06-00-00-3238527
- https://essentialpharmagroup.com/essential-pharma-strengthens-rare-disease-portfolio-with-acquisition-of-ventavis-iloprost-trometamol-for-adult-primary-pulmonary-hypertension/
- https://www.gsk.com/en-gb/media/press-releases/gsk-s-arexvy-associated-with-reductions-in-certain-rsv-related-risks-including-heart-attack-stroke-and-severe-flare-ups-of-copd-and-asthma-real-world-study-shows/
- https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-by-the-european-commission/
- https://www.fiercebiotech.com/biotech/boehringer-axes-inhaled-gene-therapy-after-viewing-cystic-fibrosis-data
- https://zyduslife.com/investor/admin/uploads/21/83/Zydus-receives-final-approval-from-USFDA-for-Bosentan-tablets-for-oral-suspension–32-mg.pdf
