Shares of Achillion Pharmaceuticals (NASDAQ: ACHN) were jumping 7.5% higher as of 10:46 a.m. EDT on Wednesday after rising as much as 18% earlier in the day. The nice gain came after the biotech announced that the Food and Drug Administration granted a Breakthrough Therapy designation for danicopan (also known as ACH-4471) in combination with Alexion's Soliris for treating the rare blood disease paroxysmal nocturnal hemoglobinuria (PNH).
Investors' positive reaction to Achillion's news today reflected their enthusiasm over the potentially smoother pathway to approval that a Breakthrough Therapy designation provides. This designation means that the FDA will essentially hold Achillion's hand through the regulatory approval process by providing guidance on clinical trials. It could also lead to danicopan receiving accelerated approval and priority review by the FDA, which reduces the time required for an approval decision.
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