PANTHERx® Rare Selected by Savara as the U.S. Exclusive Specialty Pharmacy for MOLBREEVI*

Key Terms

biologics license application regulatory

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

priority review regulatory

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

autoimmune pulmonary alveolar proteinosis medical

A rare lung disease in which the tiny air sacs that exchange oxygen become filled with excess protein and fat, like a sponge clogged with foam so it can’t hold air properly. It matters to investors because it creates specific needs for diagnostics, treatments and long-term care; the rarity and complexity drive regulatory scrutiny, clinical trial risk and potential niche market opportunities for companies developing drugs or medical devices.

granulocyte-macrophage colony-stimulating factor medical

A naturally occurring protein that acts like a fertilizer for the immune system, signaling the body to make and activate key white blood cells (granulocytes and macrophages). It matters to investors because medicines or treatments that use or target this protein can affect clinical trial outcomes, regulatory approval prospects, manufacturing needs and safety profiles—factors that can materially influence a biotech or pharmaceutical company’s value.

gm-csf medical

GM‑CSF is a naturally occurring immune signaling protein that tells certain white blood cells to grow, move and fight infection — like a traffic cop directing immune cells to where they’re needed. Investors care because drugs that boost or block GM‑CSF can treat cancers, inflammatory conditions or infectious diseases, so clinical trial results, approvals, dosing and safety concerns can materially affect a biotech or pharmaceutical company’s clinical and commercial prospects.

hypoxemic respiratory failure medical

Hypoxemic respiratory failure is a medical condition where the lungs cannot move enough oxygen into the blood, causing dangerously low oxygen levels in the body. For investors, it matters because it drives demand for treatments, hospital resources and medical devices, can lengthen hospital stays and affect clinical trial outcomes—factors that influence healthcare company revenues, cost projections and regulatory attention much like a sudden surge in demand alters a company's sales and operations.

health-related quality of life medical

A measure of how a person’s health status affects their ability to live, work and enjoy life, covering physical comfort, mental well‑being and social participation, usually captured by patient questionnaires and numeric scores. Investors care because improvements in these scores can drive regulatory approval, insurance coverage, patient demand and pricing, much like customer satisfaction ratings predict whether a product will sell and generate revenue.

nebulizer system technical

A nebulizer system is a medical device that converts liquid medication into a fine mist patients inhale so the medicine reaches the lungs directly, much like a humidifier turning water into vapor but tailored for drug delivery. It matters to investors because demand, safety, manufacturing quality, regulatory approvals and reimbursement rules determine sales and risks; upgrades or setbacks in these areas can quickly affect a company’s revenue and valuation.

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--Savara Submitted the MOLBREEVI Biologics License Application (BLA) in December 2025 for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)--

LANGHORNE, Pa.--(BUSINESS WIRE)-- 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 TheRareSP@pantherxrare.com or visit www.pantherxrare.com.

About Savara

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260108735513/en/

Media and Investor Contact:
PANTHERx Rare
Jennifer May, Senior Manager Marketing, Communications
Jmay@pantherxrare.com

Savara Inc.
Temre Johnson, Executive Director, Corporate Affairs
ir@savarapharma.com

Source: Savara Inc.