Respiratory Today—October 9, 2025

LucidQuest

1 month ago

Respiratory Health Update: PanFlu Funding, COPD Expansion, New IPF Breakthroughs and More

Leyden Labs raised €30 million from the EIC Fund and Invest-NL to advance its pan-influenza nasal spray, while Savara preps IMPALA-2 Phase 3 data for CHEST 2025. Kashiv and Alvotech moved forward with US/EU filings for their Xolair biosimilar, and Lyra Therapeutics confirmed another LYR-210 trial before NDA. Invivyd gained FDA clearance for its pivotal COVID prevention program, AeroRx secured $21 million for its nebulized COPD therapy, and Boehringer’s Jascayd became the first new IPF drug approved in a decade.

In Today’s Newsletter

💶 Leyden Labs adds €30m for pan-influenza nasal spray [1] [EU; 02 Oct 2025]

https://leydenlabs.com/20250003-news-item-leyden-labs-secures-e30-million-from-european-innovation-council-fund-and-invest-nl
Context: Equity from EIC Fund and Invest-NL to advance PanFlu nasal spray and mucosal pipeline.
Key point: Funding strengthens Europe’s pandemic preparedness and expands global investor base.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.

🫁 Savara to showcase IMPALA-2 Phase 3 data at CHEST 2025 [2] [US; 02 Oct 2025]

https://investors.savarapharma.com/news/news-details/2025/Savara-Announces-Encore-Presentations-of-Results-From-the-Phase-3-IMPALA-2-Clinical-Trial-of-Molgramostim-Inhalation-Solution-Molgramostim-in-Patients-with-Autoimmune-Pulmonary-Alveolar-Proteinosis-aPAP-at-CHEST-2025/default.aspx
Context: Oral plus posters on molgramostim in aPAP, with assay data from partner TrilliumBiO.
Key point: Company highlights efficacy by disease severity and HRQoL links; full endpoints not re-stated here.
Implication: May influence prescriber choice and payer reviews pending full data.

🔁 Omalizumab biosimilar filings advance in US/EU (Kashiv/Alvotech) [3] [06 Oct 2025]

https://www.businesswire.com/news/home/20250930481480/en/Kashiv-Biosciences-Announces-Submission-of-Biologics-License-Application-to-U.S.-FDA-and-Acceptance-of-Market-Authorization-Application-by-European-Medicines-Agency-for-ADL-018-a-Proposed-Biosimilar-to-XOLAIR-omalizumab
Context: BLA submitted to FDA; MAA accepted by EMA for ADL-018 (AVT23).
Key point: Proposed biosimilar to Xolair across multiple IgE-mediated indications.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.

🌿 Lyra sets LYR-210 path post-FDA meeting; ENLIGHTEN 2 late-breaker [4] [US; 06 Oct 2025]

https://investors.lyratherapeutics.com/news-releases/news-release-details/lyra-therapeutics-announces-clinical-plan-lyr-210-and-late
Context: Additional trial required before NDA for CRS without polyps; positive ENLIGHTEN 2 to be presented.
Key point: ENLIGHTEN 2 met primary endpoint at 24 weeks; safety similar to sham (per company).
Implication: May influence prescriber choice and payer reviews pending full data.

🛡️ Invivyd gets US IND and FDA alignment for pivotal VYD2311 program [5] [US; 06 Oct 2025]

https://investors.invivyd.com/news-releases/news-release-details/invivyd-announces-us-ind-clearance-and-alignment-us-fda-pivotal
Context: DECLARATION (Phase 3, placebo-controlled) and LIBERTY (active-controlled, combo with mRNA vaccine) outlined.
Key point: Program targets antibody-based prevention of COVID with IM dosing; timelines described by company.
Implication: May influence prescriber choice and payer reviews pending full data.

💨 AeroRx raises $21m to advance nebulized LABA/LAMA AERO-007 in COPD [6] [US; 07 Oct 2025]

https://aerorxtx.com/press-release/aerorx_therapeutics_announces_21_million_series_a_financing_to_advance_inhaled_aero-007_the_first_nebulized_laba_lama_for_copd_into_late-stage_clinical_development/
Context: Series A led by Avalon BioVentures; supports Phase 2b and late-stage prep.
Key point: Phase 2a showed 24-hour bronchodilation and tolerability in moderate–severe COPD (n=16).
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.

🧪 Merck closes Verona deal, adds Ohtuvayre (ensifentrine) COPD drug [7] [US; 07 Oct 2025]

https://www.merck.com/news/merck-completes-acquisition-of-verona-pharma/
Context: ~$10 billion acquisition completed; Ohtuvayre FDA-approved June 2024 for COPD maintenance.
Key point: Merck integrates first-in-class PDE3/4 inhibitor; Verona delisted; EPS impact noted.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.

🌬️ FDA approves Boehringer’s Jascayd for IPF, first new option in 10+ years [8] [US; 08 Oct 2025]

https://www.fiercepharma.com/pharma/boehringer-ingelheim-breathes-new-life-lung-fibrosis-treatment-market-fda-approved-jascayd
Context: Oral nerandomilast approved for IPF; company cites FVC benefit versus placebo.
Key point: Tolerability positioned vs Ofev and Esbriet; survival not statistically confirmed in pooled analysis.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Competition is building in respiratory biologics, with potential US/EU Xolair biosimilar entry affecting pricing and access [3].
Antibody-based respiratory prevention is advancing, from mucosal sprays to systemic IM options, broadening prophylaxis modalities [1][5].
COPD treatment landscape is shifting via novel mechanisms and delivery formats, from ensifentrine to nebulized dual bronchodilation [6][7].
IPF gains its first new therapy in a decade, potentially resetting expectations for efficacy and tolerability [8].
Multiple late-stage and presentation updates keep payer and clinician attention on real-world adoption and label-enabling endpoints [2][4][5].

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FAQ

What exactly did Leyden Labs fund with the €30m raise?

Equity from the EIC Fund and Invest-NL will advance the pan-influenza nasal spray (PanFlu) and broader mucosal pipeline and platform activities, per the company [1].

Is Savara releasing new IMPALA-2 data?

Savara will present encore analyses at CHEST 2025, including efficacy by disease severity and related HRQoL and exercise capacity relationships; this complements the pivotal dataset already disclosed by the company [2].

Will ADL-018 be among the first omalizumab biosimilars?

Kashiv reports US BLA submission and EU MAA acceptance for ADL-018, positioning it for potential early-wave entry if approved. Specific review timelines were not provided in the source [3].

What’s needed before Lyra can file LYR-210?

Following a September FDA meeting, Lyra plans an additional trial for CRS without polyps to support an eventual NDA, alongside presenting positive ENLIGHTEN 2 results at AAO-HNS 2025 [4].

How is Invivyd’s VYD2311 being tested?

Two trials: DECLARATION (Phase 3 vs placebo for prevention at three months) and LIBERTY (active-controlled safety and co-administration with mRNA vaccine), per FDA-aligned plans described by the company [5].

What did Merck gain by acquiring Verona Pharma?

Ohtuvayre (ensifentrine), a first-in-class COPD maintenance therapy approved in 2024, plus a cardio-pulmonary portfolio boost. Transaction value about $10 billion, per Merck [7].

Entities / Keywords

Leyden Labs; PanFlu; EIC Fund; Invest-NL; Savara; molgramostim; IMPALA-2; aPAP; CHEST 2025; Kashiv BioSciences; Alvotech; ADL-018; AVT23; Xolair biosimilar; omalizumab; Lyra Therapeutics; LYR-210; ENLIGHTEN 2; CRS; AAO-HNS; Invivyd; VYD2311; DECLARATION; LIBERTY; COVID prevention; AeroRx Therapeutics; AERO-007; LABA/LAMA; COPD; nebulized delivery; Merck; Verona Pharma; Ohtuvayre; ensifentrine; PDE3/4; Boehringer Ingelheim; Jascayd; nerandomilast; IPF; FVC.