Highlights of weekly biotech stock moves
Regulatory, clinical and other milestones
Regulatory milestones
Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) gained $5.79 to $167.04 last week after EMA accepted and granted accelerated assessment to an MAA for asfotase alfa to treat hypophosphatasia (HPP). The company expects to complete a rolling BLA submission to FDA for the product this fall.
Alexion also reported 2Q14 earnings that beat the Street, including $512.5 million in 2Q14 sales for Soliris eculizumab (see "EPS Watch," page 20).
Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) lost $0.55 to $12.66 last week after FDA approved an NDA for Ryanodex dantrolene to treat malignant hyperthermia - a potentially fatal, rare, inherited disorder usually associated with the administration of certain anesthetics or succinylcholine. The company said it plans to launch the drug next month.
NPS Pharmaceuticals Inc. (NASDAQ:NPSP) was up $0.13 to $29.22 last week after FDA said the agency's Endocrinologic and Metabolic Drug Products Advisory Committee will meet on Sept. 12 to discuss a BLA for Natpara to treat hypoparathyroidism. The
