This week’s Respiratory Research update highlights regulatory approvals, clinical development milestones, enrollment progress, strategic partnerships, and advances across asthma, fibrosis, infectious disease, and respiratory biologics.
In Today’s Newsletter
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🫁 Simcere and Stanford launch IPF research collaboration [1] [US • 12 Jun 2026]
https://en.simcere.com/news/detail.aspx?mtt=1602
Context: Simcere Pharmaceutical Group and Stanford Medicine agreed to advance exploratory respiratory research for IPF.
Key point: Simcere will fund research on a first-in-class novel molecule and may in-license 100% global rights if successful.
Implication: Signals pipeline investment and modality expansion.
🛡️ Polyrizon advances NASARIX nasal residence-time study [2] [EU • 15 Jun 2026]
https://investor.polyrizon-biotech.com/pressreleases/detail/eec74b14-4276-4acb-9c37-a4203e93e35c
Context: NASARIX (PL-14) is an investigational intranasal hydrogel allergy blocker designed as a nasal barrier.
Key point: Polyrizon signed agreements for a human performance and characterization study assessing nasal residence time.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🧬 Bambusa reports BBT002 Phase 1 MAD data [3] [Turkey • 15 Jun 2026]
https://bambusatx.com/bambusa-therapeutics-presents-positive-preliminary-multiple-ascending-dose-phase-1-data-for-bbt002-at-the-european-academy-of-allergy-clinical-immunology-eaaci-annual-congress-2026/
Context: BBT002 is a long-acting bispecific antibody targeting IL-4Rα and IL-5, presented at EAACI 2026.
Key point: Bambusa reported rapid, sustained biomarker effects, a half-life of about 29.4 days, and good tolerability in Phase 1 SAD/MAD cohorts.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 ENA Respiratory receives USPTO allowances for TLR2 assets [4] [US • 15 Jun 2026]
https://enarespiratory.com/ena-respiratory-receives-uspto-notice-of-allowance-for-two-patents-covering-tlr2-agonists-and-rhinovirus-mediated-copd-exacerbations/
Context: ENA Respiratory is developing INNA-051, a once-weekly nasal dry powder TLR2/6 agonist for respiratory viral infections.
Key point: USPTO allowed composition-of-matter and COPD rhinovirus-mediated exacerbation method-of-use patents.
Implication: Signals pipeline investment and modality expansion.
💉 GSK Canada wins Exdensur approval in severe asthma and CRSwNP [5] [Canada • 16 Jun 2026]
https://ca.gsk.com/en-ca/media/press-releases/exdensur-depemokimab-injection-approved-in-canada-for-the-treatment-of-severe-asthma-and-chronic-rhinosinusitis-with-nasal-polyps/
Context: Exdensur (depemokimab) is a long-acting IL-5 monoclonal antibody dosed every 26 weeks.
Key point: Health Canada approved Exdensur for severe eosinophilic asthma and CRSwNP, based on SWIFT and ANCHOR Phase 3 trials.
Implication: May influence prescriber choice and payer reviews pending full data.
🌎 Innoviva and Dr. Reddy’s sign XACDURO international licensing deal [6] [16 Jun 2026]
https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-announces-distribution-and-licensing-agreement-with-dr-reddys-for-xacduro-in-select-international-markets/
Context: XACDURO is a sulbactam and durlobactam antibacterial approved in the US for Acinetobacter HABP/VABP.
Key point: Dr. Reddy’s will develop, register, and commercialize XACDURO in South and Central America, the Caribbean, Russia and CIS countries.
Implication: May expand screening, initiation, and follow-up at scale.
🦠 Invivyd completes Phase 3 LIBERTY enrollment for VYD2311 [7] [US • 16 Jun 2026]
https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-completion-enrollment-phase-3-liberty-trial
Context: VYD2311 is an investigational monoclonal antibody being studied for COVID-19 prevention.
Key point: Invivyd completed enrollment in Phase 3 LIBERTY, comparing VYD2311 with an mRNA COVID-19 vaccine; topline data are expected in Q3 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 SpliSense secures CF Foundation funding for SPL84 [8] [Israel • 16 Jun 2026]
https://www.prnewswire.com/il/news-releases/splisense-secures-up-to-13-million-from-the-cystic-fibrosis-foundation-to-advance-phase-2b-study-of-spl84-for-cystic-fibrosis-302801332.html
Context: SPL84 is an inhaled antisense oligonucleotide for CF patients carrying the 3849+10kb C→T CFTR mutation.
Key point: SpliSense secured up to $13 million to support an ongoing Phase 2b study; topline results are expected in H2 2027.
Implication: Signals pipeline investment and modality expansion.
🌬️ Connect completes Seabreeze STAT Asthma enrollment [9] [US • 17 Jun 2026]
https://investors.connectbiopharma.com/news-releases/news-release-details/connect-biopharma-announces-completion-enrollment-phase-2
Context: Rademikibart is an IL-4Rα antibody being studied as adjunct therapy for acute asthma exacerbations with type 2 inflammation.
Key point: Connect enrolled 160 participants in Phase 2 Seabreeze STAT Asthma and expects topline data in early September 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 Avalyn completes MIST target enrollment for AP01 [10] [US • 17 Jun 2026]
https://investors.avalynpharma.com/news-releases/news-release-details/avalyn-completes-target-enrollment-phase-2b-mist-trial-ap01
Context: AP01 is inhaled pirfenidone for progressive pulmonary fibrosis, delivered via the investigational eFlow Nebulizer System.
Key point: Avalyn completed target enrollment of 375 patients in Phase 2b MIST; topline 12-month data are expected in H2 2027.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Respiratory biologics are moving into broader asthma, CRSwNP, COPD and acute-exacerbation settings.
- Inhaled and intranasal delivery remained a clear theme, spanning hydrogels, ASOs, pirfenidone and innate immune modulators.
- Several updates were enrollment or study-readiness milestones, setting up readouts from Q3 2026 through H2 2027.
- Commercial access activity continued, with GSK’s Canadian approval and Innoviva’s regional XACDURO licensing deal.
- Fibrosis programs were prominent, including Simcere’s exploratory IPF work and Avalyn’s PPF Phase 2b milestone.
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FAQ
What is Exdensur (depemokimab), and where was it approved?
Exdensur is GSK’s long-acting IL-5 antibody. Health Canada approved it for severe eosinophilic asthma and CRSwNP. [5]
What did Bambusa report for BBT002?
Bambusa reported preliminary Phase 1 MAD data showing sustained biomarker effects, about 29.4-day half-life, and good tolerability in healthy volunteers. [3]
What is SPL84 targeting in cystic fibrosis?
SPL84 is an inhaled ASO designed to correct the CFTR splicing defect caused by the 3849+10kb C→T mutation. [8]
When could rademikibart Seabreeze STAT Asthma data arrive?
Connect expects topline Phase 2 Seabreeze STAT Asthma data in early September 2026. [9]
What is AP01 in Avalyn’s MIST trial?
AP01 is inhaled pirfenidone for progressive pulmonary fibrosis. MIST’s primary endpoint is change in FVC at 52 weeks. [10]
What is Invivyd testing in LIBERTY?
LIBERTY compares VYD2311, an investigational COVID-19 monoclonal antibody, with an mRNA COVID-19 vaccine and co-administration. [7]
Entities / Keywords
Simcere Pharmaceutical, Stanford Medicine, idiopathic pulmonary fibrosis, IPF, first-in-class molecule, LYTAC
Polyrizon, NASARIX, PL-14, intranasal hydrogel, allergy blocker, nasal residence time
Bambusa Therapeutics, BBT002, IL-4Rα, IL-5, Type 2 inflammation, COPD, CRSwNP
ENA Respiratory, INNA-051, TLR2, TLR2/6, rhinovirus, COPD exacerbations, POSITS
GSK, Exdensur, depemokimab, IL-5, severe eosinophilic asthma, CRSwNP, SWIFT, ANCHOR
Innoviva Specialty Therapeutics, Dr. Reddy’s, XACDURO, sulbactam, durlobactam, Acinetobacter, HABP/VABP
Invivyd, VYD2311, LIBERTY, DECLARATION, REVOLUTION, COVID-19, monoclonal antibody
SpliSense, SPL84, inhaled ASO, cystic fibrosis, CFTR, 3849+10kb C→T, Cystic Fibrosis Foundation
Connect Biopharma, rademikibart, Seabreeze STAT Asthma, Seabreeze STAT COPD, IL-4Rα
Avalyn Pharma, AP01, inhaled pirfenidone, MIST, progressive pulmonary fibrosis, PPF, FVC
References
- https://en.simcere.com/news/detail.aspx?mtt=1602
- https://investor.polyrizon-biotech.com/pressreleases/detail/eec74b14-4276-4acb-9c37-a4203e93e35c
- https://bambusatx.com/bambusa-therapeutics-presents-positive-preliminary-multiple-ascending-dose-phase-1-data-for-bbt002-at-the-european-academy-of-allergy-clinical-immunology-eaaci-annual-congress-2026/
- https://enarespiratory.com/ena-respiratory-receives-uspto-notice-of-allowance-for-two-patents-covering-tlr2-agonists-and-rhinovirus-mediated-copd-exacerbations/
- https://ca.gsk.com/en-ca/media/press-releases/exdensur-depemokimab-injection-approved-in-canada-for-the-treatment-of-severe-asthma-and-chronic-rhinosinusitis-with-nasal-polyps/
- https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-announces-distribution-and-licensing-agreement-with-dr-reddys-for-xacduro-in-select-international-markets/
- https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-completion-enrollment-phase-3-liberty-trial
- https://www.prnewswire.com/il/news-releases/splisense-secures-up-to-13-million-from-the-cystic-fibrosis-foundation-to-advance-phase-2b-study-of-spl84-for-cystic-fibrosis-302801332.html
- https://investors.connectbiopharma.com/news-releases/news-release-details/connect-biopharma-announces-completion-enrollment-phase-2
- https://investors.avalynpharma.com/news-releases/news-release-details/avalyn-completes-target-enrollment-phase-2b-mist-trial-ap01
