Respiratory Today—April 10, 2026

This week’s Respiratory update highlights regulatory approvals, clinical trial progress, early-stage pipeline advances, and competitive dynamics across fibrotic, inflammatory, and rare pulmonary diseases.

In Today’s Newsletter

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🫁 Deupirfenidone publication sharpens Phase 3 IPF setup [1] [02 Apr 2026]

https://investors.puretechhealth.com/news-releases/news-release-details/puretech-announces-publication-phase-2b-elevate-ipf-trial
Context: Phase 2b ELEVATE IPF was a global, randomized, double-blind, active- and placebo-controlled trial in 257 participants over 26 weeks.
Key point: Deupirfenidone (PureTech Health; Celea Therapeutics) significantly slowed FVC decline versus placebo at 26 weeks in idiopathic pulmonary fibrosis, and the publication informed the planned Phase 3 SURPASS-IPF study.
Implication: May influence prescriber choice and payer reviews pending full data.

💊 Cipla wins US generic nintedanib approval for IPF [2] [US • 03 Apr 2026]

https://www.cipla.com/sites/default/files/Cipla_Expands_US%20_Respiratory_Portfolio_with%20Nintedanib_Capsule_%28100mg%20_150mg%29_Approval_for_Idiopathic_Pulmonary_Fibrosis_final.pdf
Context: Cipla said its product is the generic therapeutic equivalent of Ofev (Boehringer Ingelheim), for idiopathic pulmonary fibrosis.
Key point: Cipla announced US FDA final approval of its ANDA for nintedanib capsules, 100 mg and 150 mg, with launch planned on an immediate basis.
Implication: Introduces competition that may affect pricing and formulary access.

🌬️ Lunsekimig delivers in asthma and CRSwNP, misses in atopic dermatitis [3] [EU • 07 Apr 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-07-05-00-00-3268809
Context: Sanofi reported Phase 2b AIRCULES in moderate-to-severe asthma and Phase 2a DUET in CRSwNP, with VELVET as an exploratory Phase 2b study in atopic dermatitis.
Key point: Lunsekimig (Sanofi) met primary and key secondary endpoints in asthma and CRSwNP, but VELVET did not meet its primary endpoint in atopic dermatitis.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 MHRA accepts Savara’s MOLBREEVI filing in autoimmune PAP [4] [UK • 07 Apr 2026]

https://investors.savarapharma.com/news/news-details/2026/Savara-Announces-the-U-K–Medicines-and-Healthcare-Products-Regulatory-Agency-MHRA-Has-Accepted-the-MOLBREEVI-Marketing-Authorisation-Application-MAA-for-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx
Context: Savara said the UK filing follows acceptance or validation in the US and EU, and the MHRA review will run under Accelerated Review.
Key point: The UK MHRA accepted the MOLBREEVI marketing authorisation application for autoimmune pulmonary alveolar proteinosis, with a decision expected in Q4 2026.
Implication: Introduces competition that may affect pricing and formulary access.

❤️ First patient enrolled in pivotal IMPROVE-PAH study [5] [US • 07 Apr 2026]

https://www.inhibikase.com/news/press-releases/detail/140/inhibikase-therapeutics-announces-enrollment-of-first
Context: IMPROVE-PAH is a global adaptive Phase 3 program for IKT-001 in pulmonary arterial hypertension, with Part A focused on PVR and Part B on 6-minute walk distance.
Key point: Inhibikase Therapeutics enrolled the first patient in its pivotal Phase 3 IMPROVE-PAH study of IKT-001, an oral prodrug of imatinib mesylate designed to reduce GI side effects.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 AIRNA starts Phase 1 RNA-editing study in AATD [6] [US • 07 Apr 2026]

https://airna.com/news/airna-announces-first-patient-dosed-in-phase-1-trial-of-air-001-potential-best-in-class-rna-editing-therapy-for-alpha-1-antitrypsin-deficiency-aatd/
Context: RepAIR1 is an open-label Phase 1 study in adults with alpha-1 antitrypsin deficiency and PiZZ genotype, planned for about 54 patients across multiple countries. Key point: AIRNA dosed the first patient in the global Phase 1 trial of AIR-001 for alpha-1 antitrypsin deficiency and said the FDA granted orphan drug designation.
Implication: Signals pipeline investment and modality expansion.

🇨🇳 GSK secures China approval for depemokimab in CRSwNP [7] [China • 08 Apr 2026]

https://www.gsk.com/en-gb/media/press-releases/exdensur-depemokimab-approved-in-china/
Context: Approval was based on the Phase III ANCHOR-1 and ANCHOR-2 trials in chronic rhinosinusitis with nasal polyps.
Key point: China’s NMPA approved Exdensur (depemokimab, GSK) as add-on therapy with intranasal corticosteroids for adults with inadequately controlled CRSwNP.
Implication: May influence prescriber choice and payer reviews pending full data.

🦠 ModeX begins Phase 1 dosing for COVID-19 prevention antibody [8] [US • 08 Apr 2026]

https://www.opko.com/investors/news-events/press-releases/detail/540/opko-healths-modex-therapeutics-initiates-clinical-trial-of-mdx2301-for-the-prevention-of-covid-19
Context: The placebo-controlled, dose-escalation Phase 1 study is evaluating MDX2301 in healthy volunteers and adults at high risk for severe COVID-19.
Key point: ModeX Therapeutics, an OPKO Health company, said the first participants were dosed in a Phase 1 study of MDX2301, a tetravalent bispecific antibody for prevention of COVID-19.
Implication: Signals pipeline investment and modality expansion.

Why it matters

Respiratory R&D momentum was broad this week, spanning IPF, asthma, CRSwNP, autoimmune PAP, PAH, AATD, and COVID-19 prevention.
The mix of publication, regulatory, and clinical-start milestones suggests continued capital and development focus on pulmonary and adjacent immune-mediated disease.
IPF and CRSwNP saw meaningful competitive movement, with one late-stage publication and one China biologic approval.
Rare disease programs, including autoimmune PAP and AATD, advanced through both regulatory and first-in-human or early-clinical milestones.
Generic entry for nintedanib could matter commercially, especially for access and formulary discussions in IPF.

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FAQ

What changed this week for deupirfenidone in IPF?

PureTech Health and Celea Therapeutics published Phase 2b ELEVATE IPF results showing significant slowing of FVC decline versus placebo at 26 weeks, and said the data informed the planned Phase 3 SURPASS-IPF study [1].

What is the practical significance of Cipla’s nintedanib approval?

Cipla said the US FDA granted final ANDA approval for generic nintedanib capsules for idiopathic pulmonary fibrosis, with immediate launch planned. That points to potential competitive pressure in a major IPF market [2].

Did lunsekimig work across all Sanofi respiratory studies?

Not across all studies. Sanofi said lunsekimig met primary and key secondary endpoints in asthma and CRSwNP, but the exploratory atopic dermatitis study did not meet its primary endpoint [3].

Where does MOLBREEVI stand with regulators now?

Savara said MOLBREEVI is now under review in the UK, US, and EU for autoimmune PAP. In the UK, the MHRA accepted the filing under accelerated review, with a decision expected in Q4 2026 [4].

What is notable about AIR-001 in AATD?

AIRNA started Phase 1 dosing of an RNA-editing therapy designed to correct the PiZ mutation at the RNA level, and also disclosed FDA orphan drug designation for AIR-001 in alpha-1 antitrypsin deficiency [6].

What happened with depemokimab in China?

GSK said China approved Exdensur, depemokimab, for adults with inadequately controlled CRSwNP as add-on therapy with intranasal corticosteroids, based on the Phase III ANCHOR trials [7].

Entities / Keywords

Deupirfenidone: LYT-100, PureTech Health, Celea Therapeutics, ELEVATE IPF, SURPASS-IPF, idiopathic pulmonary fibrosis, IPF
Nintedanib: Cipla, Ofev, generic nintedanib, ANDA, IPF
Lunsekimig: Sanofi, AIRCULES, DUET, VELVET, asthma, CRSwNP, chronic rhinosinusitis with nasal polyps
MOLBREEVI: molgramostim inhalation solution, Savara, autoimmune PAP, pulmonary alveolar proteinosis, MHRA, MAA
IKT-001: Inhibikase Therapeutics, IMPROVE-PAH, pulmonary arterial hypertension, PAH, imatinib prodrug
AIR-001: AIRNA, alpha-1 antitrypsin deficiency, AATD, SERPINA1, PiZ, PiZZ, RNA editing, RepAIR1
Exdensur: depemokimab, GSK, NMPA, CRSwNP, ANCHOR-1, ANCHOR-2
MDX2301: ModeX Therapeutics, OPKO Health, bispecific antibody, COVID-19 prevention, Phase 1