This week’s Respiratory Research update highlights regulatory progress, late-stage clinical development, strategic partnerships, financing activity, and evolving access pathways across pulmonary diseases.
In Today’s Newsletter
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🫁 Celea Therapeutics finances deupirfenidone Phase 3 IPF trial [1] [US • 02 Jul 2026]
https://www.businesswire.com/news/home/20260701663109/en/PureTech-Founded-Entity-Celea-Therapeutics-Completes-%24180-Million-Financing-to-Advance-Deupirfenidone-as-a-Potential-New-Standard-of-Care-to-Treat-Idiopathic-Pulmonary-Fibrosis-IPF
Context: Celea Therapeutics (PureTech-founded entity) plans SURPASS-IPF, a global head-to-head Phase 3 trial in IPF.
Key point: The $180 million financing will support deupirfenidone (LYT-100) versus pirfenidone, with FVC change at week 52 as the primary endpoint.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Arcturus and Thermo Fisher align on ARCT-032 manufacturing [2] [US • 02 Jul 2026]
https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-strategic-collaboration-thermo
Context: ARCT-032 is Arcturus Therapeutics’ investigational mRNA therapy for cystic fibrosis.
Key point: Thermo Fisher Scientific will provide Phase 3 manufacturing, clinical research and commercial-readiness support.
Implication: Signals pipeline investment and modality expansion.
🇨🇦 Vertex advances ALYFTREK access pathway in Canada [3] [Canada • 06 Jul 2026]
https://www.newswire.ca/news-releases/vertex-signs-letter-of-intent-loi-with-the-pan-canadian-pharmaceutical-alliance-for-alyftrek-for-the-treatment-of-cystic-fibrosis-807026282.html
Context: ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor) is approved in Canada for eligible people with cystic fibrosis aged 6 years and older.
Key point: Vertex signed a Letter of Intent with the pan-Canadian Pharmaceutical Alliance after positive reimbursement recommendations.
Implication: May expand screening, initiation, and follow-up at scale.
🛡️ Invivyd receives PEMGARDA EUA termination notice [4] [US • 06 Jul 2026]
https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-receipt-twelve-months-advanced-notice
Context: PEMGARDA (pemivibart) is authorized for COVID-19 pre-exposure prophylaxis in certain immunocompromised adults and adolescents.
Key point: FDA sent Invivyd a Notice of Termination for the EUA, effective 29 Jun 2027 after a 12-month transition period.
Implication: Could affect access planning while Invivyd discusses next regulatory steps with FDA.
🤖 Insilico starts Phase III rentosertib IPF trial [5] [China • 07 Jul 2026]
https://insilico.com/news/xmjsn4l091-insilico-initiates-phase-iii-clinical-tr
Context: Rentosertib is Insilico Medicine’s oral TNIK inhibitor, discovered through its Pharma.AI platform.
Key point: The Phase III IPF trial is expected to enroll 320 patients across 47 centers in China over 52 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.
✂️ Prime Medicine resolves Beam arbitration over PM647 [6] [US • 08 Jul 2026]
https://investors.primemedicine.com/news-releases/news-release-details/prime-medicine-announces-positive-resolution-arbitration-beam
Context: PM647 is Prime Medicine’s investigational Prime Editing therapy for Alpha-1 Antitrypsin Deficiency.
Key point: The tribunal found PM647 is within Prime Medicine’s field under the Beam agreement, with no monetary damages owed.
Implication: Signals pipeline investment and modality expansion.
💨 AstraZeneca licenses Sino COPD candidate TQC3721 [7] [Global • 08 Jul 2026]
https://www.fiercebiotech.com/biotech/astrazeneca-pays-sino-200m-challenger-mercks-copd-drug-ohtuvayre
Context: TQC3721 is Sino Biopharmaceutical’s PDE3/4 inhibitor, with a nebulized formulation in Phase 3 in China.
Key point: AstraZeneca is paying $200 million upfront for ex-China rights, with up to $1.9 billion in milestones.
Implication: Signals pipeline investment and modality expansion.
✅ MHRA approves nerandomilast for IPF and PPF [8] [UK • 08 Jul 2026]
https://www.gov.uk/government/news/nerandomilast-jascayd-approved-to-treat-adult-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis
Context: Nerandomilast (Jascayd) is approved for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis.
Key point: MHRA approved the twice-daily oral medicine, with diarrhoea and weight loss listed as common side effects.
Implication: May influence prescriber choice and payer reviews pending full data.
🌏 Sino Biopharmaceutical gains China rights to GSK inhalers [9] [China • 08 Jul 2026]
https://www.reuters.com/legal/litigation/sino-biopharmaceutical-gsk-expand-alliance-with-china-rights-respiratory-drugs-2026-07-08/
Context: Trelegy Ellipta is used for COPD and asthma maintenance treatment; Anoro Ellipta is used for COPD maintenance treatment.
Key point: Sino Biopharmaceutical’s Chia Tai Tianqing unit secured mainland China commercialization rights from GSK.
Implication: Could streamline initiation and adherence via local commercialization and logistics.
Why it matters
- IPF competition is intensifying, with deupirfenidone, rentosertib and nerandomilast all moving across late-stage, approval or access milestones.
- Respiratory BD remains active, led by AstraZeneca’s TQC3721 deal and Sino Biopharmaceutical’s expanded GSK alliance.
- Cystic fibrosis updates span both access, via ALYFTREK in Canada, and novel modality manufacturing, via ARCT-032.
- Regulatory transition remains a key theme, especially for PEMGARDA as its EUA moves toward termination in 2027.
- Gene-editing pipeline clarity improved for Prime Medicine after the PM647 arbitration decision.
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FAQ
What is Celea Therapeutics testing in SURPASS-IPF?
Celea plans to test deupirfenidone (LYT-100) against pirfenidone in adults with IPF, with FVC change at week 52 as the primary endpoint. [1]
What does Thermo Fisher provide for Arcturus ARCT-032?
Thermo Fisher will support Phase 3 manufacturing, clinical research and commercial readiness for ARCT-032, an investigational mRNA therapy for cystic fibrosis. [2]
What changed for Vertex ALYFTREK in Canada?
Vertex signed an LOI with pCPA for ALYFTREK, enabling discussions with provinces and territories on public listings. [3]
When is the PEMGARDA EUA set to terminate?
Invivyd said the FDA Notice of Termination makes the PEMGARDA EUA termination effective on 29 Jun 2027, after a transition period. [4]
What makes Insilico’s rentosertib notable?
Rentosertib is an AI-originated TNIK inhibitor for IPF, now in a Phase III trial expected to enroll 320 patients in China. [5]
What did MHRA approve for IPF and PPF?
MHRA approved nerandomilast (Jascayd), an oral twice-daily medicine for adults with idiopathic pulmonary fibrosis and progressive pulmonary fibrosis. [8]
Entities / Keywords
Celea Therapeutics, PureTech Health, deupirfenidone, LYT-100, SURPASS-IPF, pirfenidone, idiopathic pulmonary fibrosis, IPF
Arcturus Therapeutics, Thermo Fisher Scientific, ARCT-032, mRNA therapy, cystic fibrosis, CF
Vertex Pharmaceuticals, ALYFTREK, vanzacaftor, tezacaftor, deutivacaftor, pCPA, Canada
Invivyd, PEMGARDA, pemivibart, COVID-19 pre-exposure prophylaxis, EUA, FDA, HHS
Insilico Medicine, rentosertib, ISM001-055, INS018_055, TNIK inhibitor, Pharma.AI, GENESIS-IPF
Prime Medicine, Beam Therapeutics, PM647, Prime Editing, Alpha-1 Antitrypsin Deficiency, AATD, SERPINA1
AstraZeneca, Sino Biopharmaceutical, Chia Tai Tianqing, TQC3721, PDE3/4 inhibitor, COPD, Ohtuvayre
MHRA, nerandomilast, Jascayd, progressive pulmonary fibrosis, PPF
GSK, Trelegy Ellipta, Anoro Ellipta, mainland China, asthma, COPD
References
- https://www.businesswire.com/news/home/20260701663109/en/PureTech-Founded-Entity-Celea-Therapeutics-Completes-%24180-Million-Financing-to-Advance-Deupirfenidone-as-a-Potential-New-Standard-of-Care-to-Treat-Idiopathic-Pulmonary-Fibrosis-IPF
- https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-strategic-collaboration-thermo
- https://www.newswire.ca/news-releases/vertex-signs-letter-of-intent-loi-with-the-pan-canadian-pharmaceutical-alliance-for-alyftrek-for-the-treatment-of-cystic-fibrosis-807026282.html
- https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-receipt-twelve-months-advanced-notice
- https://insilico.com/news/xmjsn4l091-insilico-initiates-phase-iii-clinical-tr
- https://investors.primemedicine.com/news-releases/news-release-details/prime-medicine-announces-positive-resolution-arbitration-beam
- https://www.fiercebiotech.com/biotech/astrazeneca-pays-sino-200m-challenger-mercks-copd-drug-ohtuvayre
- https://www.gov.uk/government/news/nerandomilast-jascayd-approved-to-treat-adult-patients-with-idiopathic-pulmonary-fibrosis-and-progressive-pulmonary-fibrosis
- https://www.reuters.com/legal/litigation/sino-biopharmaceutical-gsk-expand-alliance-with-china-rights-respiratory-drugs-2026-07-08/
