Respiratory Today—June 12, 2026

This week’s Respiratory Research update highlights regulatory milestones, clinical data readouts, trial initiations, biosimilar progress, and manufacturing developments across respiratory care.

In Today’s Newsletter

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💉 ADL-018 omalizumab biosimilar accepted by Health Canada [1] [Canada • 04 Jun 2026]

https://www.businesswire.com/news/home/20260602751703/en/Kashiv-BioSciences-Announces-Validation-and-Acceptance-of-Market-Authorization-Application-by-Health-Canada-for-ADL-018-a-Proposed-Biosimilar-to-XOLAIR-omalizumab
Context: ADL-018 targets free IgE and matches the reference product’s presentations, strength, route, and dosing regimen.
Key point: Kashiv BioSciences said Health Canada validated and accepted the MAA for ADL-018, its proposed biosimilar to XOLAIR (omalizumab).
Implication: Introduces competition that may affect pricing and formulary access.

🧬 Vertex ALYFTREK pediatric CF data at ECFS [2] [Europe • 05 Jun 2026]

https://news.vrtx.com/news-releases/news-release-details/vertex-presents-new-data-alyftrekr-european-cystic-fibrosis
Context: The open-label 24-week study enrolled 67 children; primary endpoint was safety and tolerability.
Key point: Vertex reported Phase 3 ALYFTREK data in children aged 2–5 with CF, with 65% achieving sweat chloride <30 mmol/L.
Implication: May influence prescriber choice and payer reviews pending full data.

🌬️ Upstream Bio VIBRANT CRSwNP responder analysis [3] [EU • 08 Jun 2026]

https://investors.upstreambio.com/news-releases/news-release-details/upstream-bio-showcase-additional-efficacy-data-phase-2-vibrant
Context: Verekitug is a TSLP receptor antagonist in Phase 2 trials across CRSwNP, severe asthma, and COPD.
Key point: Upstream Bio will present additional Phase 2 VIBRANT data for verekitug in CRSwNP at EAACI 2026 on 14 Jun 2026.
Implication: May influence prescriber choice and payer reviews pending full data.

🇪🇸 Lupin and ERN launch Luforbec in Spain [4] [Spain • 08 Jun 2026]

https://www.lupin.com/media/press-releases/lupin-collaborates-with-ern-for-luforbec-beclometasone-formoterol-p-mdi-launch-in-spain
Context: Luforbec is beclometasone/formoterol for adult asthma and symptomatic treatment of severe COPD.
Key point: Lupin and Laboratorios ERN announced a collaboration to launch Luforbec 100/6 pMDI in Spain.
Implication: May expand screening, initiation, and follow-up at scale.

🫁 GSK Nucala approved in Canada for COPD [5] [Canada • 09 Jun 2026]

https://ca.gsk.com/en-ca/media/press-releases/nucala-mepolizumab-approved-in-canada-for-use-in-adults-with-chronic-obstructive-pulmonary-disease-copd/
Context: Approval was based on MATINEE, METREX, and METREO Phase 3 trials; MATINEE and METREX met exacerbation endpoints.
Key point: Health Canada approved Nucala (mepolizumab) as add-on maintenance treatment for adults with COPD and raised eosinophils.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 Windward Bio starts SIRIUS COPD dosing [6] [Global • 09 Jun 2026]

https://www.globenewswire.com/news-release/2026/06/09/3308746/0/en/windward-bio-doses-first-patients-in-phase-2-sirius-copd-study-of-ultra-long-acting-anti-tslp-antibody-win378.html
Context: SIRIUS is randomized, double-blind, placebo-controlled, and dose-finding; WIN378 is an anti-TSLP antibody.
Key point: Windward Bio dosed the first patients in SIRIUS, a Phase 2 study of WIN378 in moderate-to-severe COPD.
Implication: May influence prescriber choice and payer reviews pending full data.

🛡️ Invivyd starts LIBERTY Phase 3 for VYD2311 [7] [US • 09 Jun 2026]

https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-first-participants-dosed-liberty-phase-3
Context: The study evaluates safety, tolerability, immunology, and co-administration in about 210 adults aged 18–49.
Key point: Invivyd dosed the first participants in LIBERTY, a Phase 3 trial of VYD2311 versus mRNA COVID-19 vaccine.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🏭 Matica Bio to manufacture UHN IL-10 adenoviral therapy [8] [US/Canada • 09 Jun 2026]

https://www.maticabio.com/news-events/newsroom/matica-biotechnology-announces-engagement-by-university-health-network-uhn-to-supply-cgmp-manufacturing-of-il-10-adenoviral-therapy-for-lung-transplantation/
Context: The therapy is designed for potential delivery to donor lungs during ex vivo lung perfusion before transplantation.
Key point: Matica Biotechnology will provide cGMP manufacturing for UHN’s IL-10 adenoviral gene therapy for lung transplantation.
Implication: Signals pipeline investment and modality expansion.

⚕️ Organon TOFIDENCE gains CRS and COVID-19 indications [9] [US • 10 Jun 2026]

https://www.organon.com/news/organon-secures-us-food-and-drug-administration-approval-expanding-indications-for-tofidence-tocilizumab-bavi-in-cytokine-release-syndrome-crs-and-pediatric-covid-19/
Context: TOFIDENCE is a biosimilar to ACTEMRA and is the first approved tocilizumab biosimilar entrant in the US market.
Key point: FDA approved Organon’s sBLA expanding TOFIDENCE (tocilizumab-bavi) indications to CRS and hospitalized COVID-19.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Respiratory biologics remain active across COPD, asthma, CRSwNP, and CF, with approvals, trial starts, and new datasets in the same week.
Canada was a major regulatory focus, with Health Canada activity for both ADL-018 and Nucala.
TSLP biology featured across Upstream Bio and Windward Bio programs, spanning receptor blockade and ligand inhibition.
Biosimilars continued to expand, with Kashiv’s omalizumab submission in Canada and Organon’s US TOFIDENCE label expansion.
Manufacturing and delivery infrastructure is moving alongside clinical development, including Matica Bio’s UHN gene-therapy manufacturing work.

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FAQ

What changed for Nucala (mepolizumab) in Canada?

Health Canada approved Nucala as add-on maintenance treatment for adults with COPD characterized by raised eosinophils and inadequate control on ICS/LABA/LAMA therapy. The approval cites MATINEE, METREX, and METREO. [5]

What did Vertex report for ALYFTREK in young children with cystic fibrosis?

Vertex said 65% of children aged 2–5 in a 24-week Phase 3 open-label ALYFTREK study reached sweat chloride <30 mmol/L. The primary endpoint was safety and tolerability. [2]

What is Upstream Bio presenting for verekitug?

Upstream Bio plans an EAACI 2026 oral presentation of a Phase 2 VIBRANT responder analysis in CRSwNP, focused on clinically meaningful efficacy thresholds. [3]

What is WIN378 being tested for in SIRIUS?

Windward Bio’s SIRIUS is testing WIN378, an ultra long-acting anti-TSLP antibody, in moderate-to-severe COPD. The study is Phase 2, randomized, double-blind, placebo-controlled, and dose-finding. [6]

What did FDA add to the TOFIDENCE label?

FDA approved expanded indications for CAR T cell-induced severe or life-threatening CRS and hospitalized COVID-19 in adults and pediatric patients aged 2 years and older. [9]

What is Matica Bio manufacturing for UHN?

Matica Bio will provide cGMP manufacturing services for an IL-10 adenoviral gene therapy designed for potential delivery to donor lungs during EVLP before transplantation. [8]

Entities / Keywords

Kashiv BioSciences, ADL-018, XOLAIR, omalizumab, IgE, Health Canada, Alvotech
Vertex, ALYFTREK, vanzacaftor/tezacaftor/deutivacaftor, TRIKAFTA, cystic fibrosis, sweat chloride, CFTR
Upstream Bio, verekitug, VIBRANT, TSLP receptor, CRSwNP, EAACI 2026
Lupin, Laboratorios ERN, Luforbec, beclometasone/formoterol, pMDI, asthma, COPD, Spain
GSK, Nucala, mepolizumab, IL-5, eosinophilic COPD, MATINEE, METREX, METREO
Windward Bio, WIN378, SIRIUS, POLARIS, anti-TSLP, COPD, asthma
Invivyd, VYD2311, LIBERTY, DECLARATION, COVID-19 prevention, monoclonal antibody, mRNA vaccine
Matica Biotechnology, University Health Network, UHN, IL-10, adenoviral gene therapy, EVLP, lung transplantation
Organon, TOFIDENCE, tocilizumab-bavi, ACTEMRA biosimilar, CRS, CAR T, COVID-19, FDA