EDAP Confirms FDA Panel Date, ISIS Reports Data, RedHill Touches New Peak

(RTTNews) - AbbVie (ABBV) is seeking approval for its investigational, all-oral, interferon-free therapy for the treatment of hepatitis C in Canada. The company has filed a New Drug Submission to Health Canada based on data from the largest all-oral, interferon-free clinical program in genotype 1 (GT1) chronic hepatitis C virus (HCV) infection patients conducted to date.

ABBV closed Thursday's trading at $53.63, up 0.68%.

EDAP TMS SA's (EDAP) Pre-Market Approval application for its Ablatherm-HIFU device for the treatment of localized prostate cancer is scheduled to be reviewed on July 30, 2014.

EDAP closed Thursday's trading at $3.45, up 2.37%. In after-hours, the stock gained another 4.35% to $3.60.

Isis Pharmaceuticals Inc. (ISIS) rose 7.54% on Thursday to close at $24.95 following positive top-line data from a phase II comparator-controlled study evaluating the incidence of venous thrombolic events (VTE) in patients treated with ISIS-FXIRx undergoing total knee replacement surgery, or total knee arthroplasty.

According to the trial results, patients treated with 300 mg of ISIS-FXIRx experienced a seven-fold lower incidence of VTEs compared to patients treated with anticoagulant therapy enoxaparin.

Keryx Biopharmaceuticals Inc. (KERX) dropped more than 6 percent to $12.30 in extended trading on Thursday as the FDA postponed its decision date on the company's investigational drug Zerenex by 3 months to September 7, 2014.

The company is seeking FDA approval of Zerenex for the treatment of hyperphosphatemia (elevated phosphate levels) in dialysis-dependent chronic kidney disease patients.

NeuroMetrix Inc. (NURO) has launched NC-stat DPNCheck, a rapid, accurate and quantitative point-of-care test to detect diabetic peripheral neuropathy, in Japan.

Omron Healthcare, the company's exclusive distributor for Japan and other key Asian markets, is leading the launch.

NURO closed Thursday's trading at $1.84, up 6.36%.

Protalix BioTherapeutics Inc.'s (PLX) ELELYSO (taliglucerase alfa) has been granted approval by the Australian Therapeutic Goods Administration in treating both adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease in Australia.

Australia is the first country in which ELELYSO is indicated for both adult and pediatric patients. The drug was approved for adults with Type 1 Gaucher disease by FDA in May 2012.

RedHill Biopharma Ltd. (RDHL) said that the FDA has allowed the initiation of its phase III clinical study for the treatment of a new, undisclosed indication with RHB-102, an extended release oral pill formulation of the antiemetic drug ondansetron.

The company plans to begin enrolling patients for the study during the third quarter of 2014.

RDHL touched a new high of $16.60 on Thursday before closing the day's trading at $16.48.

StemCells Inc. (STEM) is scheduled to release the first interim results from a phase I/II trial of its proprietary HuCNS-SC (purified human neural stem cells) for geographic atrophy of age related macular degeneration (GA-AMD) next month. The company is also planning to initiate a controlled phase II proof-of-concept study later this year.

STEM closed Thursday's trading at $1.37, up 3.01%. In extended trading, the stock gained another 4.38% to $1.43.