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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.
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.
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