Savara Inc. received a European patent (No. 4 496 611) on December 2, 2025 for its investigational therapy MOLBREEVI combined with the proprietary eFlow® Nebulizer System. The patent, jointly owned with PARI Pharma GmbH, protects the drug‑device combination in the European Economic Area and the United Kingdom until March 2043, extending well beyond the 10‑year orphan‑drug exclusivity that would accompany EU approval.
The grant strengthens Savara’s intellectual‑property portfolio by providing a robust, long‑term shield that deters competitors and supports the company’s planned commercialization of MOLBREEVI for autoimmune pulmonary alveolar proteinosis (PAP). Because the patent covers both the biologic and the delivery device, it secures the entire therapeutic package, which is critical for a rare‑disease indication where market entry barriers are high.
Savara is preparing a marketing‑authorization application (MAA) for MOLBREEVI in the EU and the UK in the first quarter of 2026. The company plans to market the nebulizer as the Vespera® Nebulizer System once the MAA is approved, leveraging the patent’s protection to secure a competitive advantage in the PAP treatment market. The patent also underpins the company’s strategy to expand its pipeline beyond MOLBREEVI, as the eFlow® technology can be adapted to other inhaled biologics.
In parallel, Savara is resubmitting its biologics‑license application (BLA) to the U.S. Food and Drug Administration in December 2025. MOLBREEVI has already earned Fast Track, Breakthrough Therapy, and Orphan Drug designations from the FDA and the European Medicines Agency, positioning the company for a rapid regulatory pathway in both regions. The European patent grant reinforces the company’s regulatory momentum by ensuring that any approval will be protected by a 22‑year IP shield.
The company recently completed a public offering that raised approximately $149.5 million, which will be used to fund clinical development, regulatory submissions, and commercialization infrastructure. While the balance sheet remains strong, Savara’s financial performance has been flat, with zero revenue growth over the past three years and negative earnings per share and operating margins. The patent grant is therefore a key asset that could help the company translate its clinical success into commercial revenue and improve its long‑term financial outlook.
Analysts have responded positively to the patent announcement. Oppenheimer raised its price target for Savara from $8 to $9 and maintained an Outperform rating, citing the strengthened IP position and the company’s progress toward regulatory approvals as key drivers of future upside.
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