DXCM Gets FDA Nod, MRK Breathes Easy, Neovasc Takes Heart, VRX Opens Wallet

(RTTNews) - Dexcom Inc.'s (DXCM) continuous glucose monitoring device G4 PLATINUM has received FDA approval for use in children aged 2 to 17 years with diabetes. The device is already approved for adults 18 and older.

According to the company, the Dexcom G4 PLATINUM tracks glucose levels continuously for 7 days throughout the 24-hour period using wireless technology, enabling users to view their glucose levels on demand.

DXCM touched a new 52-week high of $41.20 in intraday trading on Monday before closing at $38.98.

Galectin Therapeutics Inc. (GALT) has received FDA clearance to conduct a phase IB clinical trial of its lead drug candidate GR-MD-02 in combination with Bristol-Myers Squibb Co.'s (BMY) skin cancer drug Yervoy in patients with metastatic melanoma. The study, which will be conducted by Providence Portland Medical Center's Earle A. Chiles Research Institute, is expected to begin enrollment in March.

A phase I study of GR-MD-02 in patients with fatty liver disease (NASH) with advanced fibrosis is also underway.

GALT closed Monday's trading at $12.55, down 8.46%.

Merck & Co. Inc.'s (MRK) allergy sublingual immunotherapy tablet GRASTEK has received regulatory approval in Canada.

GRASTEK is under FDA review in the U.S. for the treatment of Timothy grass pollen-induced allergic rhinitis, with or without conjunctivitis, in individuals aged 5 to 65 years, with a decision slated in the first half of 2014. Last December, an FDA advisory committee voted unanimously to recommend approval of GRASTEK.

Yet another allergy sublingual immunotherapy of Merck - Ragwitek - is also under FDA review with a decision expected in the first half of 2014. Ragwitek won the FDA panel backing last month for the treatment of ragweed pollen induced allergic rhinitis, with or without conjunctivitis, in adults 18 to 65 years of age.

Merck has partnered with a Danish company ALK-Abello to develop its sublingual allergy immunotherapy tablets for Timothy grass pollen, ragweed pollen and house dust mite-induced allergic rhinitis in North America.

GRASTEK is already marketed in Europe as GRAZAX by ALK-Abello.

MRK closed Monday's trading at $52.08, down 1.68%.

Neovasc Inc. (NVC.V) surged over 35 percent on Monday to close at C$4.65 following news about the successful first-in-human implantation of its Tiara transcatheter mitral valve in a patient at St. Paul's Hospital in Vancouver, British Columbia, Canada.

According to the company, the transapical procedure resulted in the elimination of mitral regurgitation (MR) and significantly improved heart function in the patient, without the need for cardiac bypass support and with no procedural complications.

OPKO Health Inc. (OPK) has a strategic investment in Neovasc.

Omeros Corp.'s (OMER) drug candidate OMS721 administered either by subcutaneous injection or intravenous infusion was well tolerated and achieved the objective of a high degree of sustained lectin pathway inhibition in a phase I study.

The company expects to initiate a phase II clinical program to evaluate OMS721 in the treatment of thrombotic microangiopathies (TMAs), a family of orphan disorders, including atypical hemolytic uremic syndrome that occurs in the microcirculation of the body's organs, most commonly the kidney and brain, later this quarter.

OMER closed Monday's trading at $11.35, down 2.83%.

Portola Pharmaceuticals (PTLA) has entered into a second clinical collaboration agreement with Bayer HealthCare and Janssen Pharmaceuticals Inc. to evaluate its investigational Factor Xa inhibitor reversal agent, andexanet alfa, in phase III registration studies with FDA-approved oral Factor Xa inhibitor XARELTO. The phase III studies are expected to start in the first half of 2014.

Under the collaboration agreement, Portola will receive an upfront payment and is eligible to receive additional development and regulatory milestone payments. Portola retains full, worldwide commercial rights to andexanet alfa, which was designated as a breakthrough therapy by the FDA in November 2013 and for which Portola is pursuing an Accelerated Approval pathway.

PTLA closed Monday's trading 6.15% lower at $25.03.

Valeant Pharmaceuticals International, Inc. (VRX) (VRX.TO) has agreed to acquire privately held PreCision Dermatology Inc. for $475 million in cash, plus an additional $25 million payable upon the achievement of a sales-based milestone.

The transaction is expected to close in the first half of 2014 and Valeant expects the transaction, once completed, to be immediately accretive to Valeant's cash earnings per share.

VRX closed Monday's trading at $133.36, down 1.68%.