Savara’s IMPALA-2 Trial Success and FDA Submission Plan

Savara (SVRA) has issued an update.

Savara Inc. has announced significant success with its IMPALA-2 clinical trial, where the inhaled drug molgramostim demonstrated a meaningful improvement in lung function for autoimmune pulmonary alveolar proteinosis patients, meeting its primary endpoint at Week 24 and showing sustained effects at Week 48. Additional measures of health and physical activity also indicated benefits from the treatment. Well tolerated with a comparable rate of adverse events to the placebo, molgramostim is on track for a Biologics License Application submission to the FDA in early 2025, buoyed by multiple designations that could expedite its approval process.

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