Savara continues to rise afterhours 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).
The last 45 mins of trading today seen huge buying and a 50% surge into the close.
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.
Savara, Inc. is a clinical-stage specialty pharmaceutical company, which engages in the development and commercialization of novel therapies for the treatment of serious or life-threatening rare respiratory diseases. Its products include AeroVanc, Molgradex, GM-CSF, and Aironite. The company was founded on April 27, 2017 and is headquartered in Austin, T.