Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Amarin Corp. plc (NASDAQ:AMRN) was off $0.48 to $6.29 last week after FDA told the company that an advisory committee will meet on Oct. 16 to discuss an sNDA for hypertriglyceridemia drug Vascepa icosapent ethyl. The company is seeking to expand the label to include treatment of adults with high triglycerides with mixed dyslipidemia. The PDUFA date is Dec. 20. Amarin markets Vascepa in the U.S. as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia.
Amicus Therapeutics Inc. (NASDAQ:FOLD) fell $0.65 (20%) to $2.54 on Monday after announcing a delay for Amigal migalastat to treat Fabry's disease. According to the company, FDA said 12-month data from a Phase III trial, expected in 4Q13, would not be enough to support approval. Amicus expects to report top-line data from another Phase III trial in 2H14...