Savara Inc. develops therapies for rare respiratory diseases, with a lead program in molgramostim inhalation solution, conditionally named MOLBREEVI, for autoimmune pulmonary alveolar proteinosis. Molgramostim is a recombinant human GM-CSF delivered through an investigational eFlow Nebulizer System developed for inhalation of the large-molecule therapy.
Recurring company developments include clinical data from the IMPALA-2 program, regulatory submissions and agency-review updates in the U.S., Europe and the U.K., financial results, financing arrangements, equity inducement grants and investor conference participation. Savara's updates also note that MOLBREEVI is not approved in any indication.
Savara (Nasdaq: SVRA) announced the U.S. Food and Drug Administration has filed the BLA for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The FDA granted Priority Review with a PDUFA target action date of August 22, 2026.
The company plans to submit MAAs to EMA and MHRA by end of Q1 2026. MOLBREEVI holds Fast Track, Breakthrough Therapy, and Orphan Drug designations, plus UK Innovation Passport and PIM designations, and is positioned as a potential first and only approved therapy for autoimmune PAP in the U.S. and Europe.
Savara (Nasdaq: SVRA) granted inducement equity awards to a new employee on February 10, 2026. The awards include options to purchase 7,500 shares and 7,500 restricted stock units (RSUs).
Options carry a $5.27 exercise price, a 10-year term, quarterly vesting over four years for options, and RSUs vesting in full after two years, all subject to continued employment.
Savara (Nasdaq: SVRA) said members of management will hold one-on-one meetings and participate in fireside chats at two investor healthcare conferences in February 2026.
Fireside chat dates: Guggenheim Emerging Outlook: Biotech Summit on February 11 at 12:30pm ET and Oppenheimer 36th Annual Healthcare Life Sciences Conference on February 25 at 9:20am ET. Live webcasts and replays will be on the company Events & Presentations page and archived for 90 days.
Savara (Nasdaq:SVRA) amended its loan and security agreement with Hercules Capital (NYSE:HTGC) to make up to $75 million of additional debt available upon U.S. FDA approval of MOLBREEVI, an investigational therapy for autoimmune pulmonary alveolar proteinosis.
Combined with a previously announced $75 million royalty financing, the company would have access to approximately $150 million of non-dilutive capital to support a potential MOLBREEVI launch. Savara resubmitted the MOLBREEVI BLA in December 2025, is targeting potential approval in 3Q 2026 if Priority Review is granted, and expects to file EU/UK MAA by end of 1Q 2026.
Savara (Nasdaq: SVRA) announced inducement equity awards granted January 15, 2026 to two newly hired employees under the Savara 2021 Inducement Equity Incentive Plan pursuant to NASDAQ Rule 5635(c)(4). The awards total 17,500 stock options and 12,500 restricted stock units (RSUs). Options carry an exercise price of $5.88 (closing price on the grant date), a 10-year term, and vest at 1/16th per quarterly anniversary of the employee’s first day of employment. The RSUs vest in full after two years subject to continued employment. The grants were described as inducements material to the employees’ acceptance of employment.
Savara (NASDAQ: SVRA) announced an exclusive U.S. distribution agreement with PANTHERx Rare Pharmacy for MOLBREEVI. Savara submitted the MOLBREEVI BLA to the FDA in December 2025 and requested Priority Review. If approved, PANTHERx will dispense MOLBREEVI nationwide using its RxARECARE model and the eFlow® Nebulizer System, offering clinical case management, education, and financial and insurance assistance. PANTHERx reported 95.45% of its patients have no unresolved barriers at annual assessment.
Savara (Nasdaq: SVRA) announced it resubmitted the MOLBREEVI Biologics License Application to the U.S. FDA on December 22, 2025, naming Fujifilm as the drug substance manufacturer and requesting Priority Review.
MOLBREEVI seeks approval for the treatment of autoimmune pulmonary alveolar proteinosis (autoimmune PAP). The program previously received Fast Track and Breakthrough Therapy designations from FDA, Orphan Drug designation from FDA and EMA, and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations from the UK MHRA.
Savara (Nasdaq: SVRA) said members of management will present and host one-on-one meetings at the 44th Annual J.P. Morgan Healthcare Conference.
Presentation: Wednesday, January 14, 2026 at 5:15 PM PT / 8:15 PM ET; Presenter: Matt Pauls, Chair and Chief Executive Officer.
Location: Westin St. Francis, San Francisco, Elizabethan B Room. A live webcast and replay will be available on the company’s Events & Presentations page and will be archived for 30 days.
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.