Savara (NASDAQ:SVRA) -57.6%
pre-market after the Food and Drug Administration said data on the
development program for the company’s Molgradex lung disease treatment do not provide sufficient evidence of efficacy and safety.
SVRA says the FDA did not recommend submission of a
Biologics License Application for Molgradex, an inhaled formulation of
recombinant human granulocyte-macrophage colony-stimulating factor.
The company says it remains “committed to the
Molgradex development program and believe that it will provide aPAP
patients with a meaningful treatment option.”
https://seekingalpha.com/news/3503310-savara-slides-50-percent-plus-fda-rejects-molgradex
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