Savara soars on news of Breakthrough status for Molgradex

Texas, USA-based orphan lung disease specialist Savara Pharmaceuticals (Nasdaq: SVRA) saw its shares sky-rocket 183.8% to $4.91 by close of trading on Monday after its announcement that the US Food and Drug Administration has granted Breakthrough Therapy designation for Molgradex, its inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).

The Molgradex Breakthrough designation is based on data from IMPALA, a pivotal Phase III clinical study evaluating Molgradex for the treatment of aPAP. Data from the study was recently presented in an oral session at the 2019 European Respiratory Society (ERS) International Congress in Madrid, Spain.

“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,” said Rob Neville, chief executive of Savara.