Respiratory Today—February 13, 2026

This weekly update in Respiratory covers regulatory actions in major markets, late-stage clinical progress with new efficacy readouts, pipeline expansions across multiple indications, and health system partnerships strengthening care and research capacity.

In Today’s Newsletter

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🍼 Health Canada OKs ENFLONSIA for infant RSV prevention [1] [CA • 05 Feb 2026]

https://www.merck.ca/en/newsroom/merck-announces-health-canada-approval-of-enflonsia-for-the-prevention-of-rsv-in-newborns-and-infants/
Context: Approval supported by pivotal CLEVER (Phase 2b/3) and SMART (Phase 3) trials comparing to placebo and palivizumab.
Key point: Clesrovimab approved for prevention of RSV LRT disease in neonates and infants entering first RSV season; protection up to five months stated in label materials.
Implication: May influence prescriber choice and payer reviews pending full data.

🌐 EC approves Nucala for COPD with eosinophilic phenotype [2] [EU • 06 Feb 2026]

https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-by-the-european-commission/
Context: MATINEE Phase 3 on triple-therapy background, BEC ≥300 cells/µL; n=804.
Key point: Reduced annualized exacerbations vs placebo, rate ratio 0.79, and lowered ED/hospitalization exacerbations, rate ratio 0.65; safety similar to placebo.
Implication: May influence prescriber choice and payer reviews pending full data.

🫁 Pulmovant completes Phase 2 PHocus enrollment in PH-ILD [3] [US • 06 Feb 2026]

https://www.pulmovant.com/press-release-february-6-2026
Context: Randomized, double-blind, placebo-controlled global study, ≈120 adults; inhaled sGC activator mosliciguat.
Key point: Enrollment finished in under 12 months; topline targeted H2 2026; separate open-label PHactor combines with inhaled treprostinil.
Implication: Signals pipeline investment and modality expansion.

🧪 Devonian reports antifibrotic signals for Thykamine in IPF model [4] [CA • 10 Feb 2026]

https://groupedevonian.com/devonian-reports-positive-results-in-pulmonary-fibrosis-study/
Context: Bleomycin-induced pulmonary fibrosis mouse model; oral dosing 0.05–1 mg/kg; pirfenidone comparator.
Key point: Thykamine reduced lung weight, improved histology and fibrosis scores, and modulated fibrosis genes; pirfenidone did not reach significance on some physiological endpoints.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

📈 Kymera CEO outlines KT-621 opportunity at Guggenheim Summit [5] [11 Feb 2026]

https://m.it.investing.com/news/transcripts/kymera-al-guggenheim-biotech-summit-esplorando-il-potenziale-dei-farmaci-orali-93CH-3219248
Context: Conference transcript coverage; program updates across Type 2 diseases, including atopic dermatitis and asthma.
Key point: KT-621 aims for biologics-like efficacy in oral form; Phase II BROADEN2 in AD ongoing; management flags market expansion potential for oral options.
Implication: Signals pipeline investment and modality expansion.

🏥 Cipla Foundation to fund IISc Center for Pulmonary Medicine [6] [IN • 11 Feb 2026]

https://www.cipla.com/press-releases-statements/cipla-foundation-partners-tata-iisc-medical-school-set-centre-pulmonary
Context: Center at Tata IISc Medical School, Bengaluru, with diagnostics, inpatient care, ICU, training, and research.
Key point: Focus on India-specific COPD, ILD, asthma guidelines, biomarker research, AI diagnostics, and community programs.
Implication: May expand screening, initiation, and follow-up at scale.

🧫 Akeso’s IL-4Rα/ST2 bispecific cleared for seven Phase II studies [7] [CN • 11 Feb 2026]

https://www.prnewswire.com/news-releases/akesos-il-4rst2-bispecific-antibody-cleared-for-seven-phase-ii-studies-in-china-spanning-respiratory-and-autoimmune-indications-302684870.html
Context: NMPA approvals for AK139 across COPD, severe asthma, CSU, AR, CRSwNP, moderate to severe AD, and prurigo nodularis.
Key point: First clinical IL-4Rα/ST2 bispecific, aiming to block IL-4/IL-13 and IL-33/ST2 pathways; early studies suggest synergistic activity.
Implication: Signals pipeline investment and modality expansion.

🌬️ Upstream Bio’s verekitug hits AAER endpoint in severe asthma [8] [US • 11 Feb 2026]

https://investors.upstreambio.com/news-releases/news-release-details/upstream-bio-reports-positive-top-line-results-phase-2-valiant
Context: VALIANT Phase 2, n=478, severe asthma; q12w and q24w dosing arms.
Key point: AAER reduced 56% at 100 mg q12w and 39% at 400 mg q24w vs placebo; FEV1 and FeNO improved; safety consistent; moving to Phase 3.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Infant RSV prevention expands in Canada with a long-acting mAb option alongside existing strategies [1].
EU COPD care adds a monthly biologic for eosinophilic phenotype patients on triple therapy, with hospitalization-linked benefits reported [2].
Pipeline momentum spans inhaled sGC activation in PH-ILD and upstream cytokine targeting in asthma and CRSwNP, offering differentiated mechanisms and dosing schedules [3][8].
China’s multi-indication clearance for a dual-pathway bispecific underscores rapid modality expansion in respiratory and immunology [7].
Capacity-building in India links care delivery with research and training, targeting high-burden airway diseases [6].

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FAQ

What did Health Canada approve for RSV prevention in infants?

ENFLONSIA (clesrovimab) for prevention of RSV lower respiratory tract disease in neonates and infants entering their first RSV season, supported by CLEVER and SMART trials [1].

How did mepolizumab perform in COPD in the EU approval package?

In MATINEE, mepolizumab reduced annualized moderate to severe exacerbations vs placebo plus triple therapy, and lowered ED/hospitalization exacerbations; safety was similar to placebo [2].

What is mosliciguat and where is the program now?

A once-daily inhaled sGC activator for PH-ILD; Phase 2 PHocus completed enrollment with topline targeted for H2 2026; an open-label combo study with inhaled treprostinil is also running [3].

What is AK139 targeting and which studies were cleared?

AK139 is a bispecific antibody targeting IL-4Rα and ST2, aiming to inhibit IL-4/IL-13 and IL-33 pathways; NMPA cleared seven Phase II studies across respiratory and dermatologic indications [7].

What were verekitug’s key Phase 2 readouts in severe asthma?

VALIANT met the primary endpoint with 56% and 39% AAER reductions vs placebo in two dosing regimens, plus improvements in FEV1 and FeNO; advancing to Phase 3 after regulatory interactions [8].

What is Kymera’s KT-621 positioning per management remarks?

An oral STAT6 degrader aiming for biologics-like efficacy in Type 2 diseases; Phase II in atopic dermatitis ongoing; remarks reflect directional market opportunity rather than registrational data [5].

Entities / Keywords

Merck Canada, ENFLONSIA, clesrovimab, RSV, infants; GSK, Nucala, mepolizumab, IL-5, COPD, eosinophilic phenotype; Pulmovant, mosliciguat, sGC activator, PH-ILD; Devonian, Thykamine, idiopathic pulmonary fibrosis, bleomycin model; Kymera Therapeutics, KT-621, STAT6 degrader, atopic dermatitis, asthma; Cipla Foundation, Indian Institute of Science, Tata IISc Medical School, India respiratory health; Akeso, AK139, IL-4Rα, ST2, bispecific antibody, NMPA; Upstream Bio, verekitug, TSLP receptor, VALIANT, severe asthma.