Savara Inc.

Savara Presented New Data Showing Molgramostim Inhalation Solution (Molgramostim) Treatment Effects in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Patients with Mild Diffusion Impairment

Savara presented a CHEST 2026 poster with a post-hoc analysis of the Phase 2/3 IMPALA trial showing molgramostim treatment effects in aPAP patients with mild or normal diffusion capacity. In the small subset (8 molgramostim vs. 3 placebo patients), mean A-aDO2 improved by 12.7 mmHg at Week 24 versus 0.3 mmHg on placebo, with reductions in ground-glass opacity and improvements in quality of life. The company frames the exploratory findings, alongside Phase 3 IMPALA-2 results, as supporting molgramostim's potential to benefit aPAP patients across the severity spectrum, if approved.

•11d ago

Savara Announces Encore Presentations of Results from the Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (APAP) at the European Respiratory Society (ERS) Congress 2026

Savara announced that results from the Phase 3 IMPALA-2 trial of molgramostim in autoimmune pulmonary alveolar proteinosis will be presented at the ERS Congress 2026. Data from the 48-week open-label period showed continued improvements in lung function and exercise capacity, with biomarker reductions suggesting normalization of the underlying pathobiology. The company will host an evening mini-symposium featuring key opinion leaders to discuss disease mechanisms and clinical management.

•2mo ago

Savara Announces European and Australian Patent Offices Have Granted Patents for the Liquid Formulation of MOLBREEVI*, Providing Protection in Europe and Australia Until March 2041

Savara announced that the European Patent Office and the Australian Patent Office have granted patents covering the liquid formulation of its investigational drug MOLBREEVI. European patent No.4121000 and Australian patent No.62/990,810 provide protection for the asset through March 2041, complementing a previously granted joint patent with PARI for the drug-device combination through March 2043. Management stated that these patents strengthen the company's intellectual property portfolio in key ex-US markets while it advances equivalent filings in the U.S.

•3mo ago

Savara Presented New Biomarker Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2026

Savara presented new biomarker data from the double-blind period of its pivotal IMPALA-2 Phase 3 trial for molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP). The data showed that molgramostim significantly improved pulmonary gas transfer (DLco%) at Weeks 24 and 48 versus placebo, with p-values of 0.0007 and 0.0008 respectively. Post-hoc analyses revealed significant decreases in disease-severity biomarkers LDH, CYFRA 21-1, and KL-6 in the treatment group, which correlated strongly with improvements in lung function.

•5mo ago

Savara Announces New Exercise Capacity Data from the IMPALA-2 Phase 3 Clinical Trial of Molgramostim Inhalation Solution (Molgramostim) in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Savara presented new exercise capacity data from the double-blind period of its IMPALA-2 Phase 3 trial for molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP). Patients treated with molgramostim showed a statistically significant greater improvement in distance walked (80.6 m difference, p=0.0301) and exercise duration (1.0 minute difference, p=0.0262) compared to placebo at Week 48. These exploratory endpoints align with the trial's primary endpoint success, reinforcing the clinical benefit of the therapy for functional outcomes in aPAP patients.

•5mo ago