Achillion up on breakthrough tag for danicopan for PNH

Achillion Pharmaceuticals (NASDAQ:ACHN) is up 14% premarket in response to its announcement that the FDA has granted Breakthrough Therapy designation for danicopan (ACH-4471) for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria (PNH) who are sub-optimal responders to  a C5 inhibitor alone.

Top line data from this combination trial is expected in Q4.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Initiation of Phase 3 is planned for early 2020.

https://seekingalpha.com/news/3501681-achillion-14-percent-premarket-btd-tag-danicopan-pnh