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Monday, December 30, 2019

Savara +96% premarket on BTD tag for Molgradex for aPAP

Savara (NASDAQ:SVRA) is up 96% premarket in response to its announcement that the FDA has granted Breakthrough Therapy Designation (BTD) for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor, for the treatment of autoimmune Pulmonary Alveolar Proteinosis (aPAP).
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

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