Savara Inc. (SVRA) received a notification from the European Patent Office on December 11, 2025 that it intends to grant a patent covering the liquid formulation of its lead inhaled therapy, MOLBREEVI. The patent will provide protection in Europe through March 2041, extending the company’s intellectual‑property portfolio and reinforcing its strategy to secure exclusivity for MOLBREEVI in the European market.
The notification follows a prior EPO grant for the drug‑device combination delivered via the proprietary eFlow® Nebulizer System, which remains protected through March 2043. Together, the two patents create a robust exclusivity window that aligns with Savara’s planned regulatory submissions in the EU and UK and the 10‑year orphan drug exclusivity that would accompany a potential European approval.
Savara’s CEO Matt Pauls highlighted the strategic importance of the patents, noting that the liquid formulation and drug‑device patents “will provide protection in Europe through March 2041 and March 2043, respectively, and strengthen the Company’s intellectual property portfolio for MOLBREEVI, our potentially first‑in‑class therapy to treat autoimmune PAP.” The patents are a key asset in a market where no approved therapies exist and where the rare‑disease treatment sector is projected to reach $374 billion by 2030.
MOLBREEVI is an orally inhaled recombinant human granulocyte‑macrophage colony‑stimulating factor (GM‑CSF) being developed for autoimmune pulmonary alveolar proteinosis (aPAP). The drug has received Fast Track and Breakthrough Therapy designations from the FDA, Orphan Drug Designation from the FDA and EMA, and Innovation Passport and Promising Innovative Medicine status from the UK MHRA. Savara previously received a Refusal to File letter from the FDA in May 2025, requesting additional chemistry, manufacturing, and controls data; the company plans to resubmit its BLA in December 2025 and to file marketing authorization applications in the EU and UK by the end of Q1 2026.
Financially, Savara is a clinical‑stage biopharmaceutical company with no revenue and negative earnings, typical for its development stage. Recent strategic financings have bolstered its cash runway, positioning the company to fund the upcoming regulatory submissions and potential commercialization of MOLBREEVI. The patent news strengthens the company’s competitive moat and supports its long‑term growth strategy in the high‑growth rare‑disease market.
The market has responded positively to Savara’s pipeline progress and recent financing, with the company’s stock showing strong momentum in early December. Investors view the patent extension as a critical asset that enhances the company’s exclusivity window and underpins its commercial strategy in Europe.
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