Savara (SVRA) The Citizens Life Sciences Conference 2026 summary

Disease overview and unmet need

• Autoimmune PAP is a rare pulmonary disease with significant morbidity, often misdiagnosed for 18 months, leading to severe debilitation and increased infection risk.

• Current treatments are limited to supportive care and whole lung lavage, a burdensome and non-curative procedure.

• The disease affects a broad age range and lacks demographic predilection.

Clinical development and trial results

• Lead candidate MOLBREEVI is under FDA review with an August 22nd PDUFA date, following positive phase III data.

• IMPALA-2, the largest and longest autoimmune PAP study, enrolled 164 subjects in a 48-week double-blind, placebo-controlled trial.

• Primary endpoint (DLCO) and key secondary endpoints (SGRQ, exercise tolerance) were met with statistical significance at 24 and 48 weeks.

• 100% of trial completers enrolled in the open-label extension, indicating strong patient retention and perceived benefit.

• Data published in The New England Journal of Medicine.

Product mechanism and administration

• MOLBREEVI is an inhaled recombinant GM-CSF designed to overcome autoantibody inhibition and restore macrophage function.

• Administered once daily via nebulization, requiring about 20 minutes including setup and cleanup.

• Clinical benefit emerges gradually, with separation from placebo observed at 8–12 weeks.