This week’s Respiratory update highlights regulatory milestones, late-stage clinical progress, orphan designations, strategic acquisitions, and continued innovation across infectious disease, rare lung disorders, and gene editing.
In Today’s Newsletter
Dive deeper
🫁 BioVersys publishes Phase 2a TB data for alpibectir combo [1] [Switzerland • 19 Feb 2026]
Context: Phase 2a early bactericidal activity study in pulmonary TB (7-day EBA), conducted in South Africa (completed Apr 2024) [1].
Key point: BioVersys reported first clinical proof of concept for alpibectir (BVL-GSK098) plus ethionamide (AlpE), and publication in New England Journal of Medicine [1].
Implication: May influence prescriber choice and payer reviews pending full data.
👶 Merck posts Phase 3 SMART season-2 update for ENFLONSIA (clesrovimab) [2] [US • 19 Feb 2026]
Context: SMART (NCT04938830) evaluated safety, efficacy, PK over two RSV seasons, season-2 dose was open-label in eligible children under 2 at higher risk [2].
Key point: Merck said season-2 findings support extrapolation of efficacy to high-risk children under 2 through a second RSV season, and plans to share data with FDA and other regulators for label expansion [2].
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 YolTech reports interim IIT data for YOLT-202 in AATD [3] [China • 19 Feb 2026]
https://www.yoltx.com/news/press-release/107
Context: Investigator-initiated, open-label, single-dose escalation (NCT07193615), adults with PiZZ genotype (n small in interim update) [3].
Key point: YolTech reported dose-dependent increases in alpha-1 antitrypsin levels after a single dose, with tolerability described as favorable in evaluated participants [3].
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 PureTech/Celea: US FDA and European Commission grant orphan designations for deupirfenidone (LYT-100) in IPF [4] [US–EU • 19 Feb 2026]
Context: PureTech cited Phase 2b ELEVATE IPF results and plans for a Phase 3 SURPASS-IPF head-to-head trial (timing noted by company) [4].
Key point: Orphan Drug Designation granted in the US and EU for LYT-100 in idiopathic pulmonary fibrosis [4].
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
💰 Altesa closes $75m Series B to advance vapendavir in COPD rhinovirus infection [5] [US • 19 Feb 2026]
Context: Company described a planned Phase 2b multinational CARDINAL study in COPD patients, enrolling and randomizing at time of rhinovirus infection (design described by company) [5].
Key point: Altesa announced an oversubscribed $75m Series B (led by Forbion, joined by Sanofi and existing investors) to fund vapendavir development and initiate CARDINAL in Q2 2026 [5].
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
🧾 Savara: FDA filed MOLBREEVI (molgramostim) BLA for autoimmune PAP, Priority Review with PDUFA set [6] [US • 20 Feb 2026]
Context: MOLBREEVI is the conditionally accepted trade name for molgramostim inhalation solution (not yet approved) [6].
Key point: FDA accepted the BLA and granted Priority Review, with a PDUFA target action date of 22 Aug 2026 [6].
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
🧬 Tessera: FDA Fast Track and Orphan Drug designations for TSRA-196 in AATD [7] [US • 23 Feb 2026]
Context: TSRA-196 is co-developed with Regeneron, and Tessera stated a global first-in-human Phase 1/2 trial is underway (open-label, single IV administration) [7].
Key point: FDA granted Fast Track and Orphan Drug designations for TSRA-196 for adults with PiZZ AATD [7].
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
🌬️ Aclaris initiates Phase 1b POC trial of ATI-052 in asthma [8] [US • 24 Feb 2026]
Context: Randomized, double-blind, placebo-controlled Phase 1b POC in ~16 asthma patients (GINA steps 2–4), endpoints include biomarkers (FeNO, eosinophils) and FEV1 [8].
Key point: Aclaris said it initiated the asthma Phase 1b POC for ATI-052 (bispecific anti-TSLP/IL-4Rα) and expects topline from asthma and AD POC trials in 2H 2026 [8].
Implication: Clinical topline/efficacy: May influence prescriber choice and payer reviews pending full data.
🤖 AstraZeneca launches A.Catalyst Network Thailand Hub (AI-integrated healthcare innovation) [9] [Thailand • 23 Feb 2026]
https://www.thaipr.net/en/health_en/3696130
Context: Article describes cross-sector network aims, including an “AI-assisted lung screening” pilot in industrial estates (program details as reported) [9].
Key point: AstraZeneca (Thailand) announced the A.Catalyst Network Thailand Hub to accelerate AI and digital health adoption across partners [9].
Implication: Access programs: May expand screening, initiation, and follow-up at scale.
👃 Sanofi–Regeneron: Dupixent approved in US for allergic fungal rhinosinusitis (AFRS) [10] [US • 24 Feb 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732
Context: Approval in adults and children aged 6+ with a history of sino-nasal surgery, supported by LIBERTY-AFRS-AIMS Phase 3 (NCT04684524) [10].
Key point: FDA approved Dupixent (dupilumab) as the first medicine specifically for AFRS in eligible patients, with Phase 3 results showing improvements versus placebo across CT opacification, symptoms, and reduced systemic steroid use or surgery (per company) [10].
Implication: May influence prescriber choice and payer reviews pending full data.
🤝 GSK to acquire 35Pharma, adding pulmonary hypertension asset HS235 [11] [25 Feb 2026]
https://www.gsk.com/en-gb/media/press-releases/gsk-enters-agreement-to-acquire-35pharma-inc/
Context: GSK described HS235 as having completed Phase 1 healthy volunteer trials, with studies to start in PAH and PH-HFpEF [11].
Key point: GSK announced an agreement to acquire 35Pharma for $950m cash, bringing HS235 (activin receptor signalling inhibitor) into its Respiratory, Immunology and Inflammation portfolio [11].
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
Why it matters
-
Respiratory pipelines continue to diversify beyond inflammation, spanning antivirals (vapendavir), biologics (dupilumab, molgramostim), and gene editing (AATD programs) [5–8,10].
-
Regulators are actively shaping near-term access, with a US approval (Dupixent AFRS) and a filed BLA with a defined PDUFA date (MOLBREEVI) [6,10].
-
Pulmonary hypertension remains a major BD focus, with GSK paying for a differentiated activin-pathway approach positioned on bleeding risk and metabolic effects (claims per acquirer) [11].
-
TB innovation is still moving via combination concepts intended to overcome resistance, supported by publication-led validation [1].
🚀 Accelerate your success. Contact us now
📂 Explore our case studies. See examples of our work.
💡 Read our insights. Learn from our latest reports and analysis
🎬 Watch on YouTube. Subscribe and never miss a video.
🧰 See our full range of services. Discover how we can help you.
📚 See the full Respiratory archive on our research hub page
FAQ
What did the US FDA approve for allergic fungal rhinosinusitis (AFRS)?
Dupixent (dupilumab, Sanofi–Regeneron) was approved in the US for adults and children aged 6+ with AFRS and prior sino-nasal surgery (as described in the press release) [10].
When is the FDA decision expected for Savara’s MOLBREEVI in autoimmune PAP?
Savara said the FDA filed the BLA with Priority Review and set a PDUFA target action date of 22 Aug 2026 [6].
What is BioVersys’s AlpE concept in TB?
BioVersys described alpibectir (BVL-GSK098) as a small molecule that potentiates ethionamide, and reported Phase 2a proof-of-concept published in NEJM [1].
How is Merck positioning ENFLONSIA for high-risk children in a second RSV season?
Merck reported SMART season-2 findings and said the data will be shared with regulators to evaluate an expanded indication for children under 2 at increased risk through RSV season 2 [2].
Which AATD gene-editing programs were highlighted this week?
YolTech reported interim IIT findings for YOLT-202 (base editing) [3], and Tessera reported FDA Fast Track and Orphan Drug designations for TSRA-196 (Gene Writing) [7].
What is GSK buying in the 35Pharma deal?
GSK is acquiring 35Pharma for HS235, an activin signalling inhibitor positioned for pulmonary arterial hypertension and PH-HFpEF development (Phase 1 completed, per GSK) [11].
Entities / Keywords
-
BioVersys, alpibectir, BVL-GSK098, ethionamide, AlpE, tuberculosis, early bactericidal activity (EBA)
-
Merck (MSD), ENFLONSIA, clesrovimab, RSV, SMART trial, palivizumab
-
YolTech Therapeutics, YOLT-202, in vivo base editing, SERPINA1, alpha-1 antitrypsin deficiency (AATD), PiZZ
-
PureTech Health, Celea Therapeutics, deupirfenidone, LYT-100, idiopathic pulmonary fibrosis (IPF), Orphan Drug Designation
-
Altesa BioSciences, vapendavir, rhinovirus, COPD, CARDINAL trial
-
Savara, MOLBREEVI, molgramostim, autoimmune pulmonary alveolar proteinosis (autoimmune PAP), BLA, Priority Review, PDUFA
-
Tessera Therapeutics, TSRA-196, Gene Writing, Regeneron, Fast Track
-
Aclaris Therapeutics, ATI-052, TSLP, IL-4Rα, asthma, atopic dermatitis
-
AstraZeneca Thailand, A.Catalyst Network Thailand Hub, AI screening, chest X-ray
-
Sanofi, Regeneron, Dupixent, dupilumab, allergic fungal rhinosinusitis (AFRS), LIBERTY-AFRS-AIMS
-
GSK, 35Pharma, HS235, activin signalling inhibitor, pulmonary hypertension, PAH, PH-HFpEF
