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Savara (SVRA) investor relations material
Savara H.C. Wainwright 27th Annual Global Investment Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.H.C. Wainwright 27th Annual Global Investment Conference summary9 Sep, 2025
Disease overview and unmet need
Autoimmune PAP is a rare, chronic lung disease caused by GMCSF autoantibodies, leading to surfactant accumulation and progressive respiratory symptoms.
No approved drugs exist in the U.S. or Europe; current standard is whole lung lavage, an invasive, non-curative procedure.
Disease can progress to fibrosis and lung transplant in severe cases.
Mobrevi (morgamostim) clinical development and results
Mobrevi is a novel inhaled biologic delivered via a proprietary eFlow nebulizer, dosed once daily.
The phase 3 Impala 2 trial met its primary endpoint (DLCO improvement at 24 weeks) and showed durable effect at 48 weeks.
Secondary endpoints, including quality of life and exercise capacity, were also positive or nominally significant.
Safety profile was favorable, with a 3% discontinuation rate and no drug-related adverse events.
All 159 trial completers entered the open-label extension; results published in the New England Journal of Medicine.
Regulatory and intellectual property status
U.S. BLA resubmission planned for December, with potential PDUFA in August 2026 if priority review is granted.
EU and UK MAA submissions targeted for Q1 2025, with possible approval in Q1 2027.
Mobrevi holds orphan, fast track, and breakthrough designations in the U.S., and orphan plus innovative designations in Europe and UK.
Regulatory exclusivity of 12 years in the U.S. and ongoing global patent prosecution.
How does 'line of sight' validate US patient count?
Detail Mobrevi's IP protection beyond exclusivity.
How does APAP ClearPath aid market readiness?
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Next Savara earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
Savara Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for rare respiratory diseases. The company's main focus is on advancing its lead product candidate, molgramostim, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). In addition to molgramostim, Savara is also developing AeroVanc, an inhaled vancomycin aimed at treating methicillin-resistant Staphylococcus aureus (MRSA) lung infections in cystic fibrosis patients. Savara is headquartered in Austin, Texas, and its shares are listed on the NASDAQ.
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