LANGHORNE, PA — PANTHERx Rare Pharmacy and Savara Inc. (Nasdaq: SVRA) announced an exclusive U.S. distribution agreement for MOLBREEVI, an investigational inhaled therapy under FDA review for a rare and potentially life-threatening lung disease.
Savara said it submitted a biologics license application in December 2025 to the U.S. Food and Drug Administration for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, or autoimmune PAP, and requested Priority Review. If approved, PANTHERx will oversee dispensing and distribution nationwide and provide specialized patient and prescriber support through its proprietary RxARECARE model.
Under the agreement, PANTHERx will deliver clinical case management, disease and therapy education, and comprehensive financial and insurance assistance to patients prescribed MOLBREEVI, a move the companies say is designed to ensure timely access and sustained engagement for a small but medically complex patient population.
“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 of Savara.
MOLBREEVI is a non-glycosylated form of recombinant human granulocyte-macrophage colony-stimulating factor, or GM-CSF, administered via a proprietary eFlow nebulizer system developed by PARI Pharma GmbH. The therapy is designed to address the underlying cause of autoimmune PAP, a chronic disease in which antibodies neutralize GM-CSF, preventing immune cells known as alveolar macrophages from clearing surfactant from the lungs.
The resulting surfactant buildup interferes with gas exchange, leading to shortness of breath, fatigue, and, in severe cases, hypoxemic respiratory failure. Over time, autoimmune PAP can progress to lung fibrosis and may require lung transplantation.
Savara said MOLBREEVI is believed to help restore macrophage function, improving oxygenation, lung function, and health-related quality of life for patients living with the disease.
“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, chief executive officer of PANTHERx. He said the pharmacy’s care model is designed to remove barriers to therapy and improve adherence, a critical factor in rare disease treatment.
Founded in 2011, PANTHERx has grown into the largest independent rare disease pharmacy in the United States and is licensed in all 50 states and U.S. territories. The company holds dual rare disease accreditations from ACHC and URAC and has received multiple national awards for patient satisfaction.
Savara said the partnership positions both companies to move quickly should FDA approval be granted, marking a significant step toward expanding treatment options for patients with autoimmune PAP.
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