Baxter International Inc. (NYSE:BAX): Closing price $66.24
Baxter on Wednesday said that it has completed enrollment in its Phase III clinical trial of BAX 855, an investigational extended half-life, recombinant factor VIII treatment for hemophilia A. The ongoing trial is targeted at assessing the efficacy of the compound in lowering annualized bleed rates in both prophylaxis and on-demand treatment schedules, and will also examine its safety and pharmacokinetic profile. BAX 855 was created based on the full-length ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin-Free Method] molecule, a product having 10 years of real-world experience. The BAX 855 molecule was altered with PEGylation tech designed to extend its duration of activity in the body.
Transcept Pharmaceuticals Inc. (NASDAQ:TSPT): Closing price $3.54
Transcept has announced plans to cut expenses by implementing a reduction in force and restructuring its board. The company plans to adopt these modifications so as to conserve cash while it cooperates with Leerink Swann to explore strategies to maximize value for shareholders. Transcept plans to cut 6 employee positions, or about 43 percent of its workforce. Most of these positions will be eliminated by the end of December, with certain employees retained through a transition into early next year. Upon full implementation, this organizational change will reduce the current annualized payroll and benefit expenses by roughly $865,000.
Synergy Pharmaceuticals Inc. (NASDAQ:SGYP): Closing price $4.28
On Wednesday, Synergy announced the beginning of the first of two planned phase 3 clinical trials to confirm the safety and efficacy of plecanatide, its lead GC-C agonist and once-daily oral treatment in adult patients suffering from chronic idiopathic constipation. The pivotal phase 3 trial is a randomized, double-blind, clinical trial to compare a 12-week, dose-ranging regimen of plecanatide (3.0 and 6.0mg) against placebo in adult patients who have CIC. The study will be conducted at around 180 sites in the United States and Canada, and will enroll some 1350 patients with CIC. The primary endpoint of the study is the proportion of patients who are overall responders for the 12-week treatment period.
NPS Pharmaceuticals Inc. (NASDAQ:NPSP): Closing price $25.55
NPS reported that the FDA has accepted for review its Supplemental New Drug Application for Gattex (teduglutide [rDNA origin]) for injection. In the United States, Gattex is indicated for the treatment of adult patients who have Short Bowel Syndrome and are dependent on parenteral support. The company is looking for additions to the product label for long-term data from STEPS 2, which is a two-year open-label extension study in which 88 adult patients with SBS dependent on parenteral support received Gattex 0.05 mg/kg/day.