SVRA Savara

Savara Announces the Rare Lung Disease, Autoimmune Pulmonary Alveolar Proteinosis (aPAP), is Highlighted on a New Episode of “The Balancing Act®” Airing on Lifetime® TV

(Nasdaq: ) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that a new episode of The Balancing Act®, sponsored by Savara and featuring autoimmune Pulmonary Alveolar Proteinosis (aPAP), is airing on Lifetime TV’s Behind the Mystery™ a recurring series on The Balancing Act® television show devoted to advocating for people with rare and genetic diseases. The episode centers on the diagnostic journey of an aPAP patient and includes insights from Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and the International Coordinating Investigator for Savara’s IMPALA-2 Phase 3 clinical trial of molgramostim inhalation solution (molgramostim) in aPAP.

The episode provides a look into the real-life story of an aPAP patient—highlighting his journey to diagnosis, disease management, and need for improved treatment options. A replay of the episode can be viewed at .

“We are pleased to partner with The Balancing Act to highlight aPAP, a rare respiratory disease with no currently approved medicines in the United States or Europe and a high unmet need for patients,” said Matt Pauls, Chair and CEO, Savara. “Educating people about the hallmark signs and symptoms of aPAP, as well as the simple, accurate, non-invasive blood test to help diagnose the disease, may increase awareness for this debilitating condition and provide a quicker path to diagnosis for patients. We are committed to the global aPAP community and continue to work towards our goal of potentially providing an effective therapy for patients.”

The Company expects to complete submission of the Biologics License Application (BLA) for molgramostim in aPAP with the U.S. Food and Drug Administration (FDA) in 1H 2025.

About aPAP

Autoimmune PAP (aPAP) is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli (or air sacs) of the lungs. 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 Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune Pulmonary Alveolar Proteinosis (aPAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH). 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 . (X, formerly known as Twitter: , LinkedIn: ).

About Behind the Mystery™

Behind the Mystery™ is a recurring series on The Balancing Act® television show devoted to advocating for rare and genetic diseases. The series clarifies the often-complex issues by offering easy-to-understand explanations from top experts in the field through partnerships with foundations and pharmaceutical companies. We amplify the voices of patients, families, and advocates affected by rare diseases via our national television platform. Tune in to Behind the Mystery weekdays at 7:30 a.m. (ET/PT) on Lifetime® and find all previously aired episodes on .

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 regarding education potentially leading to increased awareness of aPAP and a quicker path to diagnosis, Savara’s goal of potentially providing an effective therapy, and the anticipated timing of Savara’s BLA submission. 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 molgramostim for aPAP; the actions and decisions of regulatory authorities; the risks and uncertainties related to the impact of widespread health concerns or 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.

EN
22/10/2024

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on Savara

 PRESS RELEASE

Savara Announces the Rare Lung Disease, Autoimmune Pulmonary Alveolar ...

LANGHORNE, Pa.--(BUSINESS WIRE)-- (Nasdaq: ) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that a new episode of The Balancing Act®, sponsored by Savara and featuring autoimmune Pulmonary Alveolar Proteinosis (aPAP), is airing on Lifetime TV’s Behind the Mystery™ a recurring series on The Balancing Act® television show devoted to advocating for people with rare and genetic diseases. The episode centers on the diagnostic journey of an aPAP patient and includes insights from Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, U...

 PRESS RELEASE

Savara Announces New Employment Inducement Grant

LANGHORNE, Pa.--(BUSINESS WIRE)-- (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to four new employees. On October 17, 2024, the Compensation Committee of Savara's Board of Directors granted the inducement awards to four new employees who recently joined the Company. The inducement awards consist of options to purchase an aggregate of 95,000 shares of the Company’s common stock and restricted stock units (RSUs) covering an aggregate of 95,000 shares of the Company’s common stock. These equity awa...

 PRESS RELEASE

Savara Announces Patient Journey Map for People Living with Autoimmune...

LANGHORNE, Pa.--(BUSINESS WIRE)-- (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced the acceptance of an abstract for poster presentation at the CHEST 2024 Annual Meeting, taking place October 6-9 in Boston. The Company is also sponsoring an Industry Symposium at the meeting. Details are as follows: Accepted Abstract Title: “A Patient Journey Map for People Living with Autoimmune Pulmonary Alveolar Proteinosis (aPAP)” Poster Session: Diffuse Lung Disease Abstracts Posters (D) Date and Time: October 8, 2024, 1:45 - 2:30pm ...

 PRESS RELEASE

Savara Announces New Employment Inducement Grant

LANGHORNE, Pa.--(BUSINESS WIRE)-- (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the grant of inducement awards to a new employee. On September 25, 2024, Savara's Board of Directors granted the inducement awards to Braden Parker, who joined the Company as Chief Commercial Officer on September 24, 2024. The inducement awards consist of options to purchase 170,000 shares of the Company’s common stock and restricted stock units (RSUs) covering 85,000 shares of the Company’s common stock. These equity awards were granted under the...

 PRESS RELEASE

Savara Announces Expanded Access Program (EAP) for Molgramostim Inhala...

LANGHORNE, Pa.--(BUSINESS WIRE)-- (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the Savara Early Access Program, a molgramostim Expanded Access Program (EAP) for patients with aPAP. The program enables physicians to request molgramostim for eligible aPAP patients in select geographies where the product is not commercially available and in compliance with local regulatory requirements. The Savara Early Access Program has been reviewed and allowed to proceed by the U.S. Food and Drug Administration (FDA), and it i...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch