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Respiratory Today—June 19, 2026

Respiratory Today

Respiratory Today

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.

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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

  1. https://en.simcere.com/news/detail.aspx?mtt=1602
  2. https://investor.polyrizon-biotech.com/pressreleases/detail/eec74b14-4276-4acb-9c37-a4203e93e35c
  3. 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/
  4. https://enarespiratory.com/ena-respiratory-receives-uspto-notice-of-allowance-for-two-patents-covering-tlr2-agonists-and-rhinovirus-mediated-copd-exacerbations/
  5. 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/
  6. https://innovivaspecialtytherapeutics.com/innoviva-specialty-therapeutics-announces-distribution-and-licensing-agreement-with-dr-reddys-for-xacduro-in-select-international-markets/
  7. https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-completion-enrollment-phase-3-liberty-trial
  8. 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
  9. https://investors.connectbiopharma.com/news-releases/news-release-details/connect-biopharma-announces-completion-enrollment-phase-2
  10. https://investors.avalynpharma.com/news-releases/news-release-details/avalyn-completes-target-enrollment-phase-2b-mist-trial-ap01
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