Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon U.S. Food and Drug Administration (FDA) Approval of MOLBREEVI*
-- When Combined with Recently Announced
Under the terms of the amended loan agreement, up to an additional
“In anticipation of the potential approval of MOLBREEVI later this year, Savara will be well capitalized with
“Hercules Capital is thrilled to continue our partnership with Savara as they prepare for the potential launch of MOLBREEVI,” said Tom Hertzberg, Managing Director, Hercules Capital.
The Company resubmitted the MOLBREEVI Biologics License Application (BLA) to the FDA in December 2025. If Priority Review is granted, MOLBREEVI could potentially be approved in 3Q 2026. The Company remains on track to file the Marketing Authorization Applications (MAA) for MOLBREEVI in
In October 2025, Savara announced its entry into a
“We have shown strong operational excellence over the last few quarters and believe that positive momentum will continue,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “The Company resubmitted the MOLBREEVI BLA to the FDA, completed a
About Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in aPAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, MOLBREEVI*, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at www.savarapharma.com and LinkedIn.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
Forward-Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” and “will,” among others. Such statements include, but are not limited to, statements related to the potential impact of the amendment, including the funds available for the launch of MOLBREEVI when combined with the royalty financing with RTW, the impact of Priority Review and the timing of FDA approval for MOLBREEVI, that Savara will be well capitalized to support launch activities, the anticipated timing of the MAA submissions in
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Media and Investor Relations Contact
Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com
Source: Savara Inc.