Savara Inc Stock Price, News & Analysis

Savara (Nasdaq: SVRA) said the European Patent Office intends to grant a patent for the liquid formulation of MOLBREEVI, which would provide protection in Europe through March 2041. The company also noted a separate European patent already granted for the drug-device combination of MOLBREEVI delivered via PARI’s eFlow® nebulizer, covering protection through March 2043.

Savara said MOLBREEVI would be eligible for 10 years of Orphan Drug exclusivity in the EU upon approval. The company expects to resubmit the MOLBREEVI BLA to the FDA in December 2025 and to file MAA submissions in the EU and U.K. by the end of 1Q 2026. MOLBREEVI holds FDA Fast Track and Breakthrough Therapy designations, FDA and EMA Orphan Drug designations, and MHRA IP and PIM designations for autoimmune PAP.

Savara (Nasdaq: SVRA) and PARI were granted European Patent No. 4 496 611 covering the drug-device combination of MOLBREEVI delivered via the eFlow® Nebulizer System.

The patent covers the combination through March 2043. The company cited a 10-year Orphan Drug regulatory exclusivity upon EU approval and noted an exclusive license with PARI. Savara plans a December resubmission of the MOLBREEVI BLA in the U.S. and 1Q 2026 MAA submissions in Europe and the U.K. Regulatory designations include FDA Fast Track, Breakthrough Therapy, FDA and EMA Orphan Drug, and the UK’s Innovation Passport and PIM designations. The eFlow system is planned for commercial launch as the Vespera Nebulizer System if approved.

Savara (Nasdaq: SVRA) said members of its management team will hold one-on-one meetings and take part in fireside chats at two investor healthcare conferences in early December 2025.

Fireside chat schedule: Piper Sandler 37th Annual Healthcare Conference on Dec 2, 2025 at 2:30pm ET and Evercore ISI 8th Annual Healthcare Conference on Dec 4, 2025 at 10:00am ET. Live webcasts and replays will be available in the company’s Events & Presentations section and archived for 90 days.

Savara (NASDAQ: SVRA) reported third quarter 2025 results and a business update on November 12, 2025. The company said it is on track to resubmit the MOLBREEVI BLA for autoimmune pulmonary alveolar proteinosis in December 2025 and will request priority review. Savara expects to submit Marketing Authorization Applications to the EMA and MHRA in 1Q 2026. Recent financings strengthened the balance sheet: a public equity offering that added ~$140M and a ~$75M royalty funding agreement; cash, cash equivalents and short-term investments were ~$124.4M as of September 30, 2025. Q3 net loss was $29.6M (loss per share $(0.14)); research and development and commercial preparations continued.

Savara (Nasdaq: SVRA) said members of its management team will host 1x1 meetings and participate in fireside chats at two upcoming healthcare conferences.

Fireside chats: Guggenheim 2nd Annual Healthcare Innovation Conference on November 10, 2025 at 8:30 a.m. ET, and Jefferies London Healthcare Conference on November 19, 2025 at 12:00 p.m. GMT. Live webcasts and replays will be available in the company’s Events & Presentations section and will be archived for 90 days.

Savara (NASDAQ:SVRA) announced the closing of its underwritten public offering on October 31, 2025, raising approximately $149.5 million in gross proceeds before fees. The offering included 28,452,381 shares of common stock sold at $4.20 per share, which reflects the full exercise by the underwriters of their option to purchase 4,642,857 additional shares. In lieu of shares, certain investors bought 7,142,857 pre-funded warrants at $4.199 each. The securities were offered under Savara's shelf registration (File No. 333-279274); the final prospectus supplement was filed on October 30, 2025.

Savara (Nasdaq: SVRA) priced an underwritten public offering on October 30, 2025 of 23,809,524 shares of common stock at $4.20 per share and, in lieu of common stock to certain investors, 7,142,857 pre-funded warrants at $4.199 each, for total gross proceeds of $130.0 million. The company also granted a 30-day underwriter option to purchase up to 4,642,857 additional shares.

The offering is expected to close on October 31, 2025, subject to customary conditions. Proceeds are intended for general corporate purposes, including funding clinical development and regulatory approval for MOLBREEVI, commercialization infrastructure and supply, U.S. and EU commercial launch preparation, and general and administrative expenses.

Savara (Nasdaq: SVRA) announced a proposed underwritten public offering of shares of common stock and, for certain investors, pre-funded warrants on October 29, 2025. The offering is subject to market and other conditions and may not be completed.

Savara said it intends to use proceeds for general corporate purposes, including funding clinical development and regulatory approval efforts for MOLBREEVI, investing in commercialization infrastructure and supply, U.S. and EU commercial launch preparation, and general and administrative expenses. Underwriters have a 30-day option to purchase up to an additional 15% of the offered shares and pre-funded warrants. Jefferies, Piper Sandler, and Guggenheim are joint book-running managers.

Savara (NASDAQ: SVRA) announced a $75 million royalty funding agreement with RTW Investments to support a potential U.S. launch of MOLBREEVI for autoimmune pulmonary alveolar proteinosis (autoimmune PAP), contingent on FDA approval and customary closing conditions.

The financing is non-dilutive, becomes available upon approval, and pays RTW a tiered single‑digit percentage of U.S. annual net sales for MOLBREEVI subject to a cap. Savara plans to resubmit the MOLBREEVI BLA in December 2025 and cites pivotal IMPALA-2 results as supporting commercial potential.