This morning orphan lung disease company Savara Inc. (SVRA:NASDAQ) announced that "the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)."
The company advised that "the Molgradex Breakthrough Therapy designation is based on data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex for the treatment of aPAP." According to the report, the data from the study was recently presented in Madrid to the 2019 European Respiratory Society International Congress.
Savara explained in the release that "Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on various clinically significant endpoints".
The company's CEO Robert Neville commented, "We are pleased that the FDA recognized Molgradex as a breakthrough therapy for the treatment of aPAP, a debilitating rare lung disease with no approved pharmacologic treatment options...We believe this designation reflects the significance of Molgradex as an investigational product that, based on the IMPALA study, has been demonstrated to improve patient outcomes. Breakthrough designation is designed to provide increased collaboration and more frequent dialogue with the FDA and is an important milestone as we work to determine the best path forward for this product."
Savara is an orphan lung disease company headquartered in West Lake Hills, Tex., and states that "its management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization." The company listed that "its pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF."
Savara has a market capitalization of about $71.3 million with approximately 41.2 million shares outstanding. SVRA shares opened nearly 140% higher today at $4.12 (+$2.39, +138.15%) compared to Friday's $1.73 closing price. The stock has traded today between $3.26 and $4.87/share on extremely high relative volume and currently is trading at $4.07 (+$2.34, +135.26%).
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