The health care sector was relatively flat Thursday, as investors weighed an array of regulatory and clinical trial updates from companies.
(BSM) said Thursday that the Food and Drug Administration completed a pre-approval audit -- which included a five-day onsite inspection of its manufacturing process -- of its BSD-2000 hyperthermia system.
The company said the FDA didn't provide any written inspectional deficiencies, but it didn't allude to when it expects an approval decision. Shares added 51 cents, or 9.4%, to $5.96.
(ZGEN) fell Thursday after announcing after the prior bell that the
FDA review of its rThrombin
blood clotting product would take an additional three months. The FDA needs the extra time to review additional data on a manufacturing facility. Shares were down $1.30, or 9.8%, at $11.98.
Other companies got a slight bump out of initiating or reporting data from mid-stage trials.
said a phase II dose-finding study achieved its primary endpoint and showed a statistically significant dose-response relationship of COL-118, a topical treatment for Erythema, a bright redness of the skin which is associated with certain dermatological conditions. Shares rose 18 cents, or 1.5%, to $12.18.
(REGN - Get Report)
said Thursday that it initiated two double-blind, placebo-controlled phase III trials evaluating the safety and efficacy of aflibercept, which it's developing with Sanofi-Aventis, in combinations with standard chemotherapy regimens in patients with prostate cancer and nonsmall cell lung cancer.