seralutinib (GB002) / Gossamer Bio, Pulmokine - LARVOL DELTA

Late Breaking Abstract - Exploratory analysis of a PDGFRB protein quantitative trait locus and seralutinib treatment response in the phase 3 PROSERA PAH study (ERS 2026) - P3 | "Conclusions In this pharmacogenetic analysis of a PDGFRB pQTL in a PDGFR-targeted therapy trial in PAH, a compelling allele-dose efficacy gradient was observed linking rs2304058 and circulating PDGFRβ to clinical response. Concordance from genotype to protein to treatment effect supports PDGFRβ engagement and suggests pathway activity can modulate sensitivity to seralutinib, warranting further prospective evaluation for precision medicine approaches."

Late-breaking abstract • P3 data • Cardiovascular • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • PDGFRA • PDGFRB

Late Breaking Abstract - Effects of seralutinib on pulmonary vascular remodeling assessed by quantitative CT: A randomized, double-blind, placebo-controlled imaging substudy of the phase 3 PROSERA trial (ERS 2026) - "Conclusions Seralutinib was associated with a multi-compartment FRI reverse remodeling signature that correlated with clinical outcomes in the phase 3 PROSERA study. These results are biologically coherent and support mechanistic alignment with clinical improvement."

Clinical • Late-breaking abstract • P3 data • Cardiovascular • Fibrosis • Immunology • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CSF1R • KIT • PDGFRA

Comparative and combined effects of seralutinib and nintedanib suggest synergistic anti-fibrotic and anti-inflammatory activity in IPF patient-derived lung models (ERS 2026) - P3 | "Seralutinib showed antifibrotic activity comparable with nintedanib, and a more pronounced anti-inflammatory effect. Combined inhibition of complementary kinase pathways produced synergistic antifibrotic and anti inflammatory activities, supporting therapeutic potential of seralutinib–nintedanib combination in IPF, PH-ILD, and related fibrotic lung diseases."

Clinical • Cardiovascular • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Inflammation • Pulmonary Arterial Hypertension • PDGFRA • TIMP1

PDGF pathway: tyrosine kinase inhibitors (ERS 2026) - "More recently, there has been renewed interest in this group of medications, prompted by the development of inhaled seralutinib together with further study of imatinib. This presentation will review the pleotropic effects of TKIs in PAH and the evidence supporting the use of selected TKIs in PAH."

Cardiovascular • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Targeted genetic profiling of PAH-predisposing genes and exploratory seralutinib response by genotype in the phase 3 PROSERA study (ERS 2026) - P3 | "Targeted genetic profiling in a phase 3 PAH trial identified clinically relevant genetic subgroups. Ongoing variant classification and BMPR2 treatment-response analyses will clarify the potential value of genetic stratification for advancing personalized medicine in PAH."

P3 data • Cardiovascular • Heart Failure • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • ACVRL1 • KDR • SOX17

Inhaled Precision: Seralutinib's Targeted Approach to Pulmonary Arterial Hypertension (AHA 2026) - No abstract available

Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) (clinicaltrials.gov) - P3 | N=330 | Recruiting | Sponsor: Gossamer Bio USA, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Reacquisition of Worldwide Commercial and Development Rights for Seralutinib from Chiesi (Businesswire) - "Gossamer and Chiesi agreed to terminate their Collaboration and License Agreement. As a result of the termination, Gossamer has reacquired worldwide development and commercial rights to seralutinib from Chiesi, consolidating global development and commercial control of the program under Gossamer ahead of the planned NDA submission....The termination agreement requires Chiesi to make a one-time $5 million payment to Gossamer shortly after signing, settling all outstanding and future obligations under the prior collaboration, including second-quarter 2026 costs. Gossamer makes no upfront cash payment to reacquire the rights."

Commercial • Pulmonary Arterial Hypertension

Regulatory Interactions: Type B Pre-NDA Meeting, Receipt of FDA Meeting Minutes and Planned NDA Submission (Businesswire) - "The Company held a Pre-NDA Type B meeting with the FDA in mid-June 2026 and has since received the official meeting minutes. Based on the meeting minutes, the FDA characterized the degree of statistical significance and the magnitude of the treatment effect observed in PROSERA as review issues rather than filing issues. On that basis, the Company intends to submit an NDA supported by one adequate and well-controlled study (Phase 3 PROSERA) plus confirmatory evidence (Phase 2 TORREY and supportive analyses). FDA provided feedback on the format and content of the planned NDA submission. The Company plans to submit the NDA for seralutinib in PAH in September 2026. If accepted for filing, seralutinib could be eligible for an FDA approval decision in the third quarter of 2027."

FDA approval • FDA event • FDA filing • Pulmonary Arterial Hypertension

Pulmonary arterial hypertension from a translational perspective: Bridging pathophysiology and treatment. (PubMed, Chin Med J (Engl)) - "Agents targeting the BMP/TGF-β axis (e.g., sotatercept), growth factor signaling (seralutinib), inflammatory pathways (tocilizumab, rituximab), and metabolic remodeling (pyruvate dehydrogenase kinases [PDK] and fatty acid oxidation [FAO] modulators) are redefining treatment paradigms. Concurrently, large-scale multi-omics initiatives such as PVDOMICS and PHOENIKS enable deep phenotyping, which unravels molecular endotypes and informs precision medicine approaches. This review summarizes the pathophysiology of PAH and the ongoing clinical trials in the PAH field."

Journal • Cardiovascular • Fibrosis • Hypertension • Immunology • Inflammation • Metabolic Disorders • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • SOX17 • TGFB1

Clinical research on pulmonary hypertension from a 2025 perspective: a narrative review. (PubMed, J Thorac Dis) - "Most notably, sotatercept, its validation in reduce clinical worsening expanded across diverse patient populations. Alongside, optimized use of classical pathways (endothelin, nitric oxide, prostacyclin) and emerging targeted therapies (e.g., seralutinib, imatinib) may bring more clinical benefits...Furthermore, right ventricular targeted therapies have received increasing attention and improved outcomes for patients. The convergence of sophisticated risk stratification tools and mechanism-based therapeutics in 2025 established a robust foundation for improving survival and quality of life in PH patients."

Journal • Review • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

VRN131326: A selective PDGFR inhibitor ameliorates pulmonary arterial hypertension as a monotherapy and in combination with sotatercept in preclinical models (PHA 2026) - "Compared with seralutinib, it showed lower VEGFR2 inhibitory potency, suggesting a reduced risk of systemic hypertension. Overall, VRN131326 shows potent disease-modifying potential, a favorable safety profile, and synergistic benefit with sotatercept, supporting its development as a promising novel therapeutic approach for PAH."

Combination therapy • Monotherapy • Preclinical • Cardiovascular • Hematological Disorders • Hypertension • Pulmonary Arterial Hypertension • Respiratory Diseases

Circulating Biomarker Results From a Phase 2 Study of Seralutinib in Pulmonary Arterial Hypertension. (PubMed, Am J Respir Crit Care Med) - No abstract available

Biomarker • Journal • P2 data • Cardiovascular • Hypertension • Inflammation • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

New Targets, New Trials in PAH: A New Hope? (ISHLT 2026) - "This talk will explore emerging therapeutic targets in pulmonary arterial hypertension (PAH), such as drugs targeting the BMPR2 and activin signaling pathways. It will highlight novel agents such as Sotatercept, Seralutinib, and Ralinepag, emphasizing how these therapies may redefine and reshape the future treatment landscape of PAH."

Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

GB002-2102: "Clinical Study of Inhaled GB002 for the Treatment of WHO Group 1nPulmonary Arterial Hypertension (PAH)" (clinicaltrialsregister.eu) - P1/2 | N=11 | Active, not recruiting | Sponsor: GB002 Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

SERANATA: Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P3 | N=480 | Suspended | Sponsor: GB002, Inc. | Recruiting ➔ Suspended

Trial suspension • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Seralutinib for the Treatment of Pulmonary Arterial Hypertension (PAH): Results From the Phase 3 PROSERA Trial (ATS 2026) - No abstract available

Late-breaking abstract • P3 data • Cardiovascular • Pulmonary Arterial Hypertension • Respiratory Diseases

Open-label Extension Study of Seralutinib in Adult Subjects With PAH (PROSERA-EXT) (clinicaltrials.gov) - P3 | N=316 | Active, not recruiting | Sponsor: GB002, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA) (clinicaltrials.gov) - P3 | N=390 | Completed | Sponsor: GB002, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

SERANATA: Efficacy and Safety of Seralutinib in Adult Subjects With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD) (clinicaltrials.gov) - P3 | N=480 | Recruiting | Sponsor: GB002, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Hypertension • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Seralutinib decreases endotrophin (PRO-C6) production, a mediator of fibrosis and inflammation, in an in vitro model of pulmonary fibrosis (ERS 2025) - P2 | "By day 12, seralutinib treatment reduced PRO-C6 levels in a concentration-dependent manner (1.3- to 2.3-fold), with 1000 nM seralutinib reducing PRO-C6 levels to those observed in unstimulated cells. Conclusion Seralutinib decreased PRO-C6 production in an in vitro model of pulmonary fibrosis providing a compelling rationale to further investigate its potential as a surrogate biomarker of pulmonary fibrosis and its role in the pathophysiology of vascular remodeling in PH."

Preclinical • Cardiovascular • Fibrosis • Hepatology • Immunology • Inflammation • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • COL6A3

Seralutinib increases small pulmonary artery vessel volume and reduces vessel wall remodeling: Insights from AI-driven CT imaging analysis (ERS 2025) - "In this exploratory analysis, seralutinib improved metrics of vascular remodeling, correlating with hemodynamic changes. These results support seralutinib's effect on remodeling and highlight the utility of AI-driven CT imaging in treatment evaluation in PAH."

Cardiovascular • Hypertension • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

Seralutinib shows significant anti-fibrotic effects: Evidence from patient-derived models (ERS 2025) - P2 | " PCLS from two IPF patient donors were cultured and treated for 4 days with vehicle, seralutinib (0.1- 10μM), or nintedanib (1μM). These data support investigation of seralutinib as a potential inhaled treatment option for diseases characterized by underlying pulmonary vascular and interstitial fibrosis, including PH and other ILDs."

Clinical • Cardiovascular • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Interstitial Lung Disease • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • KIT • MMP3 • PDGFRA • TIMP1

Seralutinib targets fibrotic pathways in IPF: Evidence from single-cell transcriptomics (ERS 2025) - P2 | "Conclusions. Seralutinib downregulated pathways elevated in IPF disease-relevant cell populations, suggesting a broad, multi-cellular impact on fibrosis, thus supporting the development of seralutinib as a novel inhaled therapy for fibrotic lung diseases."

Cardiovascular • Fibrosis • Idiopathic Pulmonary Fibrosis • Pulmonary Arterial Hypertension • COL1A1 • COL6A3 • ITGB1

Seralutinib demonstrates in vitro reduction of vascular inflammatory drivers underlying pulmonary hypertension (ERS 2025) - P2 | "Conclusions Seralutinib demonstrated broad anti-inflammatory effects across multiple in vitro vascular inflammation models. These findings, combined with clinical biomarker data, highlight seralutinib's potential for reducing the underlying inflammation in PH, and merit further investigation."

Preclinical • Cardiovascular • Inflammation • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases • CSF2 • CXCL8 • CXCL9 • IFNG • IL17A • IL1B • IL4 • TLR4 • TNFA • VCAM1