Savara announced that the U.S. Food and Drug Administration granted Fast Track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor. Molgradex, the Company’s lead product candidate, is being investigated in a pivotal Phase 3 study, called IMPALA, for the treatment of autoimmune pulmonary alveolar proteinosis. Topline results from the study are expected in June 2019. Positive results would facilitate the submission of a Biologics License Application in the first half of 2020, with an anticipated commercial launch later in 2020 or early 2021.
https://thefly.com/landingPageNews.php?id=2903653
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