PANTHERx® Rare Selected by Savara as the U.S. Exclusive Specialty Pharmacy for MOLBREEVI*
--Savara Submitted the MOLBREEVI Biologics License Application (BLA) in December 2025 for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)--
PANTHERx® Rare Pharmacy, the trusted leader and innovator in patient access and support services for personalized rare disease care, and Savara Inc. (NASDAQ:SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced an exclusive distribution agreement for MOLBREEVI. Savara submitted the MOLBREEVI BLA to the U.S. Food and Drug Administration (FDA) in December 2025 for the treatment of autoimmune PAP. Priority Review was requested.
If approved, PANTHERx and its team of rare care experts will be responsible for the dispensing and distribution of MOLBREEVI in the U.S and will leverage its proprietary RxARECARE® model to deliver highly specialized rare disease patient and prescriber support services, including clinical case management, disease and therapy education, and comprehensive financial and insurance assistance.
"Our selection of PANTHERx as the exclusive U.S. specialty pharmacy for MOLBREEVI underscores Savara's commitment to delivering more than a medicine—we will be delivering a complete care experience for patients," said Braden Parker, Chief Commercial Officer, Savara. "This partnership reflects our shared mission to improve the lives of patients with autoimmune PAP by making their journey to therapy as smooth and supportive as possible."
MOLBREEVI, a non-glycosylated form of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), is an inhaled investigational medicine being developed for autoimmune PAP, a rare and chronic lung disease caused by GM-CSF autoantibodies which block GM-CSF signaling and reduce surfactant clearance—resulting in difficulty breathing and, ultimately, hypoxemic respiratory failure. MOLBREEVI, administered via a proprietary eFlow® Nebulizer System (PARI Pharma GmbH) is believed to help restore the surfactant-clearing activity of macrophages, thus improving oxygenation, lung function, and health-related quality of life (HRQoL).
"We are proud to partner with Savara to support the launch of MOLBREEVI and help ensure eligible patients with autoimmune PAP receive timely access and ongoing engagement throughout their treatment journey," said Bansi Nagji, CEO of PANTHERx. "By driving therapy adherence and persistence, PANTHERx will work with Savara to help optimize outcomes for individuals living with autoimmune PAP through our proven care model. 95.45% of the patients served by PANTHERx have no unresolved barriers at their annual assessment1, and we are committed to delivering that same level of success to this community."
About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
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 autoimmune PAP, 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 exchange, 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 lung infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
About PANTHERx Rare
PANTHERx Rare makes rare disease care more hyper-personalized and less overwhelming by focusing relentlessly on each patient and each therapy. PANTHERx experts develop deep personal relationships with patients, prescribers, and pharmaceutical partners, serving as trusted advocates to ensure seamless collaboration and exceptional care. Since its founding in a garage in Pittsburgh, PA in 2011, PANTHERx has grown into the largest independent rare pharmacy in the U.S., leveraging established-company resources while maintaining small-company responsiveness, innovation, and attention to detail.
PANTHERx is licensed in all 50 states and U.S. territories and was the first national pharmacy to achieve dual accreditations in rare disease from the Accreditation Commission for Health Care (ACHC) and Utilization Review Accreditation Commission (URAC). PANTHERx is also the eight-time winner of the prestigious MMIT Patient Choice Award for patient satisfaction, including the 2025 honor.
For more information, please email [email protected] or visit www.pantherxrare.com.
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 approval of MOLBREEVI, the role, responsibilities, and planned actions of PANTHERx following such approval and their impact on individuals living with autoimmune PAP, that we will be delivering a complete care experience for patients, and that MOLBREEVI is believed to help restore the surfactant-clearing activity of macrophages, thus improving oxygenation, lung function, and health-related quality of life. Savara may not actually achieve any of the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the risks associated with our ability to successfully develop, obtain regulatory approval for, and commercialize MOLBREEVI for autoimmune PAP; the risks and uncertainties related to the impact of changing economic or geopolitical conditions; the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations; the availability of sufficient resources for Savara's operations and to conduct or continue planned clinical development programs; and the timing and ability of Savara to raise additional capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.
1 PANTHERx RARE Program Management Data, 2024.
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Media and Investor Contact:
PANTHERx Rare
Jennifer May, Senior Manager Marketing, Communications
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Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
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