Savara Inc. (SVRA) stock surged 6.80% in after-hours trading on Wednesday, following the announcement that the results of its pivotal Phase 3 IMPALA-2 clinical trial will be published in the prestigious New England Journal of Medicine (NEJM). The publication, scheduled for August 21, 2025, highlights the efficacy of Savara's inhaled molgramostim therapy for autoimmune Pulmonary Alveolar Proteinosis (PAP), a rare respiratory disease.
The IMPALA-2 trial, described as the largest and longest Phase 3 clinical trial conducted in autoimmune PAP, demonstrated significant improvements in patients after 48 weeks of daily molgramostim administration. Key findings include reduced pulmonary surfactant burden, improved pulmonary gas transfer, enhanced respiratory health-related quality of life, and increased patient functionality. Importantly, the treatment was well-tolerated with no notable safety concerns.
This publication in NEJM represents a major milestone for Savara Inc., potentially paving the way for future regulatory approvals and commercialization of molgramostim for autoimmune PAP. The positive market reaction reflects investor optimism about the company's progress in addressing this rare disease and the potential impact on Savara's future prospects in the pharmaceutical industry.