Shares of Dova Pharmaceuticals Inc (NASDAQ: DOVA) trading was halted Monday morning in anticipation of a stock-sensitive announcement.
The FDA announced its approval for Dova's New Drug Application for its lead product candidate Doptelet — chemically avatrombopag — indicated to treat thrombocytopenia in chronic liver disease patients who are scheduled to undergo a medical or dental procedure.
Thrombocytopenia is a condition where the platelet count drops to low levels, causing internal bleeding.
The agency accepted the NDA in November, while also giving it priority review status.
The submission was based on two Phase 3 trials, dubbed ADAPT 1 and ADAPT 2, in which the drug candidate met all primary and secondary end points.
Why It's Important
The FDA said in the release that Doptelet is the first drug approved for the indication.
"Doptelet was demonstrated to safely increase the platelet count. This drug may decrease or eliminate the need for platelet transfusions, which are associated with risk of infection and other adverse reactions," Richard Pazdur, the director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, said in a statement.
Competition is close behind, as Japan's Shionogi & Co Ltd also has a pending NDA for a similar drug.
The NDA for lusutrombopag, Shionogi's investigational once-daily, orally administered, small-molecule thrombopoietin receptor agonist, was accepted for review in February, and the PDUFA action date is set for Aug. 26.
Shares resumed trading around 1:15 p.m. ET and last traded down 6 percent at $26.23.
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