Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Actavis plc (NYSE:ACT) gained $3.09 to $234.38 last week after FDA's Cardiovascular and Renal Drugs Advisory Committee voted 6-4 against approval of an NDA for a fixed-dose combination of nebivolol and valsartan to treat hypertension. The product has a Dec. 24 PDUFA date.
Amarin Corp. plc (NASDAQ:AMRN) fell $0.32 (18%) $1.49 on Friday after FDA's Office of New Drugs denied the company's appeal seeking to reinstate an SPA for the Phase III ANCHOR trial of Vascepa icosapent ethyl. The trial was evaluating Vascepa in combination with statins to treat high triglycerides in patients with mixed dyslipidemia, an indication Amarin is seeking to add to Vascepa's label. FDA revoked the SPA last year. Amarin said it is evaluating OND's response and has