SVRA News & Events

Savara presented a poster at the ATS 2026 International Conference that is taking place May 15-20, 2026, in Orlando, Florida. The poster reported new biomarker data from the double-blind period of the IMPALA-2 Phase 3 clinical trial evaluating molgramostim for the treatment of aPAP. Poster Board 401: "Relationship Between Pulmonary Gas Transfer and Biomarker Levels in Patients with Autoimmune Pulmonary Alveolar Proteinosis." Presented serum biomarker data from IMPALA-2, a Phase 3 clinical trial in which aPAP patients received nebulized molgramostim 300 microgram or placebo once daily for 48 weeks. Blood samples were collected at baseline and at Weeks 4, 12, 24, and 48, measuring levels of Krebs von den Lungren protein-6, cytokeratin 19 fragments, carcinoembryonic antigen, lactate dehydrogenase, hemoglobin, and hematocrit. Molgramostim significantly improved pulmonary gas transfer, as measured by change from baseline in percent predicted diffusing capacity of the lungs for carbon monoxide adjusted for hemoglobin at Week 24 and Week 48 versus placebo. Post-hoc analyses showed that patients in the molgramostim group also demonstrated significantly greater mean decreases from baseline in LDH, and KL-6 compared with placebo. Strong correlations were observed in the overall study population between improvements in DLco% and decreases in LDH. Conclusions: Biomarker levels associated with aPAP disease severity decreased in patients treated with molgramostim. Additionally, decreased levels of biomarkers were associated with improvements in pulmonary gas transfer.

"With approximately $203M in cash and, upon MOLBREEVI approval, access to up to an additional $150Min non-dilutive capital through debt and royalty structures, we remain well capitalized to fund global commercial launch preparations," said Matt Pauls, Chair and CEO, Savara. "With a PDUFA action date of November 22nd, U.S. commercial planning momentum is building. Our newly deployed Rare Disease Specialists are actively driving disease awareness for autoimmune PAP and advancing launch readiness initiatives for MOLBREEVI-a potentially first and only treatment for autoimmune PAP."

Savara "announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months. The Agency is reviewing the molgramostim BLA under Priority Review and the new PDUFA target action date is November 22, 2026. The FDA determined that the Company's responses to recent information requests by the Agency constituted a major amendment to the BLA, resulting in a three-month extension of the PDUFA date. The Agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence. This extension allows the FDA additional time to complete their review of the BLA, including recently submitted materials related to information requests."