Savara Inc. has resubmitted its Biologics License Application for MOLBREEVI, the inhaled granulocyte‑macrophage colony‑stimulating factor therapy for autoimmune pulmonary alveolar proteinosis (aPAP), and has requested priority review from the U.S. Food and Drug Administration.
The resubmission follows a Refusal to File letter issued in May 2025 that cited incomplete Chemistry, Manufacturing, and Controls data. The new application incorporates updated CMC information and names Fujifilm Biotechnologies as the drug‑substance manufacturer, addressing the FDA’s concerns and positioning the file for substantive review.
aPAP is a rare lung disease with an estimated global prevalence of fewer than 5,000 patients in the United States. MOLBREEVI would be the first pharmacologic treatment for the condition, and industry estimates place the addressable market at roughly $400 million annually. Approval would therefore unlock a significant revenue opportunity for Savara and provide patients with a less invasive alternative to whole‑lung lavage.
Savara’s financial statements show that the company reported a net loss of $45 million in Q4 2024 and $52 million in Q1 2025, driven largely by research and development and general‑administrative expenses. Cash and short‑term investments stood at $196 million as of December 31 2024 and $172 million as of March 31 2025, giving the company a runway of 18–24 months at current burn rates. The company has also secured additional debt financing to support ongoing clinical development and potential commercialization.
Chairman and CEO Matt Pauls said, “We are confident that the updated CMC data and partnership with Fujifilm Biotechnologies will satisfy the FDA’s requirements, and we remain committed to advancing MOLBREEVI toward approval.” He added that the company’s clinical data demonstrate meaningful improvements in pulmonary gas transfer and quality‑of‑life outcomes for patients with aPAP.
The resubmission and priority‑review request signal that Savara is actively pursuing a faster regulatory path, which could bring the drug to market earlier than the typical 12‑month review window. Successful approval would not only provide a new treatment option for aPAP patients but also strengthen Savara’s pipeline and financial prospects, potentially influencing future capital‑raising and partnership opportunities.
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