Savara gets FDA breakthrough status despite large, late-stage failure
Savara watched their stock crater in June as they announced a late-stage failure on their lead compound. But now, based on the same Phase III trial, the FDA is giving the biotech and its rare lung disease drug breakthrough therapy designation.
The designation comes for Molgradex, an inhalant meant to treat autoimmune pulmonary alveolar proteinosis (aPAP). It was the lead compound in Savara’s 2016 buyout of Serendex. The disease is caused by autoantibodies that neutralize a protein called GM-CSF in the lungs, and the inhalant replenishes the lungs with a recombinant form of the protein.
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