Sept. 16 Quick Takes: AZ’s danicopan meets in Phase III

AstraZeneca plc (LSE:AZN; NASDAQ:AZN) said is readying regulatory filings for danicopan to treat paroxysmal nocturnal hemoglobinuria (PNH) after the oral factor D inhibitor met the primary endpoint of change in hemoglobin from baseline at 12 weeks in a Phase III study of patients also receiving the pharma’s C5 inhibitor therapies Ultomiris ravulizumab or Soliris eculizumab. The trial also met secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score. Danicopan was central to the acquisition of Achillion Pharmaceuticals Inc. by Alexion Pharmaceuticals Inc. at the end of 2019; AZ acquired Alexion a year later.

Six months after approval by FDA, the EC approved Opdualag nivolumab/relatlimab from Bristol Myers Squibb Co. (NYSE:BMY) to treat unresectable or metastatic melanoma with tumor cell PD-L1 expression <1%. Opdualag, a fixed dose combination of relatlimab and the pharma’s marketed PD-1 inhibitor Opdivo nivolumab, is the first drug targeting LAG3 to have received regulatory approval. ...