Savara reports positive data from molgramostim trial in rare lung disease

LANGHORNE, Pa. - Savara Inc. (NASDAQ:SVRA), a $741.63 million market cap biotechnology company that has seen its shares surge over 20% in the past six months, announced additional analyses from its Phase 3 IMPALA-2 trial of molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP) at the European Respiratory Society Congress 2025 in Amsterdam. According to InvestingPro data, analysts maintain a bullish outlook on the stock, with price targets ranging from $7 to $16.

The data showed that molgramostim, an inhaled GM-CSF therapy, demonstrated improvement compared to placebo in lung diffusing capacity (DLco%) regardless of disease severity at baseline. The treatment showed significant benefits in both patients with more severe disease (DLco% ≤50%) and those with less severe disease (DLco% >50%).

According to the findings presented, changes in DLco%, which was the primary endpoint in the IMPALA-2 trial, significantly correlated with improvements in quality of life measures, exercise capacity, and reduction in surfactant accumulation in the lungs.

Francesco Bonella, M.D., Ph.D., from Ruhrlandklinik University Hospital in Germany, presented data supporting DLco% as a clinically meaningful measure in aPAP, showing its association with both clinical outcomes and the extent of pulmonary pathology.

In a separate presentation, Savara’s partner TrilliumBiO showcased the development of a novel dried blood spot test for detecting GM-CSF autoantibodies, which could potentially improve diagnosis of aPAP. The test demonstrated strong correlation with traditional blood sampling methods and showed high precision and sensitivity.

Autoimmune pulmonary alveolar proteinosis is a rare lung disease characterized by abnormal build-up of surfactant in the lungs due to neutralizing antibodies against GM-CSF, which impairs the function of alveolar macrophages responsible for clearing surfactant.

The IMPALA-2 trial is a global, 48-week, randomized, double-blind, placebo-controlled study evaluating molgramostim 300 mcg administered daily by inhalation in patients with aPAP, with primary efficacy assessment at 24 weeks.

The information in this article is based on a press release statement from Savara Inc. For deeper insights into Savara’s financial health, valuation metrics, and detailed analysis of its clinical pipeline potential, access the comprehensive Pro Research Report available exclusively on InvestingPro, which covers over 1,400 US stocks with expert analysis and actionable intelligence.

In other recent news, Savara Inc. announced significant developments in its Phase 3 IMPALA-2 clinical trial for its molgramostim inhalation solution. The trial, which is the largest conducted for autoimmune pulmonary alveolar proteinosis (aPAP), demonstrated notable improvements in pulmonary gas transfer compared to a placebo. The results are set to be published in the New England Journal of Medicine. Additionally, JMP Securities reiterated its Market Outperform rating for Savara, citing strong Phase 3 data that highlights the unmet need in treating aPAP. Guggenheim raised its price target for Savara to $11, following updates on manufacturing for its drug Molbreevi and alignment with the FDA on Biologics License Application resubmission requirements. H.C. Wainwright also increased its price target to $8, driven by an updated health claims record analysis for aPAP patients in the U.S. Furthermore, Savara’s partner, TrilliumBiO, will present research on a new diagnostic tool for aPAP at the European Respiratory Society Congress 2025. This presentation will focus on a dried serum assay for detecting GM-CSF antibodies, which are crucial for diagnosing aPAP.

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