Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
AMAG Pharmaceuticals Inc. (NASDAQ:AMAG) fell $3.58 (15%) to $20.37 on Thursday after disclosing in an SEC filing that FDA has not yet discussed with the company proposed labeling or postmarketing requirements for Feraheme ferumoxytol, even though an sNDA for the anemia drug has a Jan. 21 PDUFA date. AMAG is seeking to expand Feraheme's label to include treatment of all adult patients with iron deficiency anemia who have failed or could not tolerate oral iron treatment.
Last week, AMAG was off $3.14 (13%) to $20.79.
Celgene Corp. (NASDAQ:CELG) was unchanged at $169.81 last week after the European Commission approved a Type II variation to expand the label of Abraxane nab-paclitaxel to include first-line treatment of metastatic pancreatic cancer in combination with gemcitabine. CHMP backed the label expansion in November.
Chelsea Therapeutics International Ltd. (NASDAQ:CHTP) fell $1.03 (29%) to $2.50 on Friday after an FDA reviewer said there is "inadequate evidence of effectiveness" for Northera droxidopa to treat symptomatic neurogenic orthostatic hypotension (NOH) and recommended the agency issue a complete response letter. The recommendation came in briefing documents released ahead of a meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee on Tuesday this week to discuss a resubmitted NDA for the