This respiratory update spotlights reflects strong momentum across respiratory and immunology, with multiple regulatory approvals, late-stage trial initiations, and key BLA and IND milestones.
In Today’s Newsletter
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🧪 Sanofi’s efdoralprin alfa gets EU orphan tag in AATD emphysema [1] [EU • 17 Dec 2025]
https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-17-06-00-00-3206714
Context: EMA grants orphan designation to efdoralprin alfa (SAR447537; INBRX-101) in AATD-related emphysema.
Key point: Phase 2 ElevAATe reportedly met all primary and key secondary endpoints vs plasma-derived SOC (endpoints not specified).
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
🇺🇸 JASCAYD (nerandomilast) wins FDA approval for PPF 🎉 [2] [US • 19 Dec 2025]
Context: PDE4B inhibitor adds second US indication after IPF.
Key point: FIBRONEER-ILD showed smaller FVC decline vs placebo at 52 weeks; safety broadly consistent with IPF experience.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.
💸 GSK enters US pricing and access agreement for respiratory meds [3] [US • 19 Dec 2025]
Context: Voluntary pact with US Administration addresses Medicaid pricing and direct purchasing platform.
Key point: Company to lower prices on certain medicines and offer up to 66% savings via direct channel.
Implication: Access programs. May expand screening, initiation, and follow-up at scale.
📄 Savara resubmits BLA for MOLBREEVI in autoimmune PAP [4] [US • 22 Dec 2025]
Context: BLA resubmission names Fujifilm as drug-substance manufacturer; Fast Track, Breakthrough, Orphan designations cited.
Key point: Priority Review requested; product is inhaled molgramostim via eFlow nebulizer.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧬 Aqualung gets FDA IND clearance for Phase 2a in PPF [5] [US • 22 Dec 2025]
Context: ALT-100 mAb targets eNAMPT; PAISANO study cleared after ARDS experience.
Key point: FDA waived prior IPF study requirement based on preclinical and safety package; start contingent on funding.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
🛡️ Invivyd starts DECLARATION Phase 3 for VYD2311 COVID prophylaxis [6] [US • 23 Dec 2025]
Context: Triple-blind, placebo-controlled trial in adults and adolescents.
Key point: Primary endpoint is reduction of PCR-confirmed symptomatic COVID at 3 months; single IM dose and monthly-dose arms, n≈1770.
Implication: DTC/telehealth. Could streamline initiation and adherence via remote prescribing and logistics.
👧 Dupixent approved in Japan for pediatric asthma 6–11 [7] [JP • 23 Dec 2025]
https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-23-06-00-00-3209661
Context: MHLW expands label to children with severe or refractory disease.
Key point: VOYAGE Phase 3 showed reduced exacerbations and improved lung function vs placebo; EXCURSION open-label data supportive.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧷 Mabwell’s anti-ST2 9MW1911 cleared by FDA for US Phase IIa in COPD [8] [US • 24 Dec 2025]
https://mabwell.com/en/news_info/id-201.html
Context: IND clearance follows China Phase IIa signal in moderate–severe COPD (n=80).
Key point: Prior data suggested dose-dependent exacerbation reduction at RP2D (numbers not restated here); US Phase IIa to initiate.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🇩🇰 SoftOx wins DMA approval for Phase 2a SIS trial in CF [9] [DK • 29 Dec 2025]
Context: Combined dose-escalation in healthy volunteers and PoC in CF.
Key point: First human efficacy-oriented assessment of SoftOx Inhalation Solution targeting biofilm infections.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
📨 FDA accepts BLA for INO-3107 in adult RRP (standard review) [10] [US • 29 Dec 2025]
Context: Accelerated-approval filing; FDA questions eligibility for that pathway.
Key point: PDUFA target 30 Oct 2026; company plans meeting to discuss accelerated-approval status.
Implication: Regulatory/generics. Introduces competition that may affect pricing and formulary access.
🇨🇳 Nucala (mepolizumab) approved in China for COPD add-on [11] [CN • 05 Jan 2026]
https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-in-china/
Context: NMPA approval in adults with COPD and raised eosinophils.
Key point: Based on METREX and MATINEE Phase 3 showing reduced moderate/severe exacerbations vs placebo plus SOC.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🫁 Transpire Bio doses first human with novel inhalation formulation [12] [US • 06 Jan 2026]
Context: Initial clinical study to assess safety, tolerability, PK for inhaled candidate targeting CNS disorders.
Key point: Program aims at Parkinson’s disease psychosis and other CNS conditions, alongside pulmonary pipeline.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
🌿 Bambusa doses first patient in Phase Ib COPD study of BBT002 [13] [US • 06 Jan 2026]
Context: Bispecific antibody targets IL-4Rα and IL-5 across type 2 respiratory indications.
Key point: Study assesses safety, PK/PD; initial data expected 2H 2026.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🌬️ Apogee’s zumilokibart shows interim asthma Ph1b signal [14] [US • 06 Jan 2026]
Context: Double-blind, placebo-controlled Ph1b in mild–moderate asthma with elevated FeNO.
Key point: Single 720 mg dose produced durable FeNO suppression through 16 weeks for all patients, with safety acceptable; 32-week follow-up available for some.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🇯🇵 Exdensur (depemokimab) approved in Japan for severe asthma and CRSwNP [15] [JP • 06 Jan 2026]
https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/
Context: MHLW approval based on SWIFT and ANCHOR Phase 3 programs.
Key point: Twice-yearly dosing reduced asthma exacerbations and improved CRSwNP outcomes vs placebo plus SOC.
Implication: Clinical topline/efficacy. May influence prescriber choice and payer reviews pending full data.
🧫 Krystal to share interim high-dose KB407 CF data (call notice) [16] [US • 07 Jan 2026]
Context: CORAL-1 Phase 1 dose-escalation in cystic fibrosis.
Key point: Upcoming interim update to cover transduction and CFTR expression after inhaled KB407.
Implication: Partnerships/BD. Signals pipeline investment and modality expansion.
Why it matters
- Approvals in Japan and China expand biologic options across asthma, CRSwNP, and COPD, potentially shifting regional standards of care [11][15][7].
- US PPF approval for nerandomilast introduces a novel PDE4B approach in fibrosing ILDs, reinforcing momentum in this class [2].
- Multiple early- to mid-stage respiratory programs, from anti-ST2 to bispecifics and inhaled platforms, diversify mechanisms addressing type 2 inflammation and infection [8][9][12][13][14].
- Regulatory progress for rare airway diseases (autoimmune PAP, RRP) underscores attention to underserved indications [4][10].
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FAQ
What did FIBRONEER-ILD show to support nerandomilast’s PPF approval?
A statistically smaller decline in FVC vs placebo at 52 weeks, with tolerability similar to placebo in discontinuation rates; secondary composite endpoint was not statistically significant overall [2].
How will depemokimab be dosed in Japan?
Twice yearly. SWIFT showed significant reductions in annualized asthma exacerbations, and ANCHOR improved CRSwNP measures versus placebo plus SOC [15].
What is Nucala’s new COPD label in China?
Add-on maintenance in adults with COPD characterized by raised eosinophils, supported by METREX and MATINEE reductions in moderate/severe exacerbations vs placebo plus SOC [11].
What is in Savara’s MOLBREEVI resubmission?
A revised BLA naming Fujifilm as drug-substance manufacturer, seeking approval in autoimmune PAP with a Priority Review request; product is inhaled molgramostim [4].
What did Apogee’s zumilokibart interim readout show in asthma?
Single-dose treatment led to durable FeNO suppression through 16 weeks for all patients with acceptable safety, supporting infrequent dosing exploration [14].
What is FDA’s stance on INOVIO’s accelerated approval request?
FDA accepted the BLA for standard review and flagged insufficient information for accelerated-approval eligibility; INOVIO plans to meet FDA to discuss options [10].
Entities / Keywords
Sanofi; efdoralprin alfa; SAR447537; INBRX-101; AATD • Boehringer Ingelheim; JASCAYD; nerandomilast; PPF; FIBRONEER-ILD • GSK; pricing agreement; US Medicaid • Savara; MOLBREEVI; molgramostim; autoimmune PAP • Aqualung Therapeutics; ALT-100; eNAMPT; PPF • Invivyd; VYD2311; DECLARATION; monoclonal antibody; COVID prophylaxis • Dupixent; dupilumab; pediatric asthma • Mabwell; 9MW1911; anti-ST2; IL-33/ST2; COPD • SoftOx; SoftOx Inhalation Solution; cystic fibrosis; biofilm • INOVIO; INO-3107; RRP; BLA • Nucala; mepolizumab; COPD; eosinophils • Transpire Bio; inhaled CNS therapy • Bambusa Therapeutics; BBT002; IL-4Rα; IL-5; COPD; bispecific • Apogee Therapeutics; zumilokibart; APG777; IL-13; FeNO • Exdensur; depemokimab; IL-5; asthma; CRSwNP • Krystal Biotech; KB407; CFTR; cystic fibrosis.
References
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https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-17-06-00-00-3206714
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https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-23-06-00-00-3209661
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https://www.gsk.com/en-gb/media/press-releases/nucala-mepolizumab-approved-in-china/
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https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-japan/