AVNR Excites Investors, MRK To File Odanacatib NDA In 2015, Watch Out For ZSPH

(RTTNews) - Avanir Pharmaceuticals Inc. (AVNR) rose more than 85 percent on Monday following the release of positive phase II trial data of AVP-923, the company's investigational drug for the treatment of agitation in patients with Alzheimer's disease.

The results demonstrated that treatment with AVP-923 was associated with significantly reduced agitation. Agitation, one of the symptoms of Alzheimer's disease, is said to be the most common reason for moving Alzheimer's patients out of their homes into higher levels of care.

Avanir plans to request a meeting with both the FDA and the European Medicines Agency to discuss initiation of pivotal development program for AVP-923 for the treatment of agitation in patients with Alzheimer's disease.

AVNR touched a new high of $13.09 on Monday before closing at $12.49, up 85.31% from the previous day's close.

BioTime Inc.'s (BTX) subsidiary OncoCyte Corp. and Abcodia Ltd., a UK-based company, have entered into a collaboration to develop OncoCyte's blood-based PanC-Dx test for early detection of breast cancer.

OncoCyte is currently sponsoring four clinical studies of PanC-Dx in bladder, breast, and lung cancer. OncoCyte retains all rights to develop and market its proprietary breast cancer diagnostic products.

BTX closed Monday's trading at $3.57, unchanged from the previous day's close.

Merck & Co. Inc. (MRK) said that its pivotal phase III fracture outcomes study for Odanacatib in postmenopausal women with osteoporosis met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine and non-vertebral fractures compared with placebo.

According to the trial results, adjudicated events of morphea-like skin lesions and atypical femoral fractures occurred more often in the Odanacatib group than in the placebo group. While the adjudicated major adverse cardiovascular events were generally balanced overall between the treatment groups, there were numerically more adjudicated stroke events with Odanacatib than with placebo.

Merck now expects to submit the NDA for Odanacatib with the FDA in 2015.

MRK closed Monday's trading at $59.52, down 0.05%.

ZS Pharma Inc.'s (ZSPH) two week, pivotal phase III trial of its investigational treatment for hyperkalemia, ZS-9, has demonstrated that once-daily dosing of the compound prevented the recurrence of hyperkalemia in patients with heart failure taking a stable dose of renin angiotensin aldosterone system (RAAS) inhibitor therapy.

A second phase III study of ZS-9 in treating patients with hyperkalemia is underway, and the company plans to file a NDA with the FDA and a Marketing Authorization Application with the European Medicines Agency in the first half of 2015.

ZSPH closed Monday's trading at $37.63, down 4.73%.