CLVS Gets Panel Date, XBIO Abuzz, FDA Says No To Broader Use Of Zetia, Vytorin

(RTTNews) - Cutera Inc.'s (CUTR) enlighten picosecond laser platform has received marketing clearance from both Health Canada and the Taiwanese Ministry of Health and Welfare. Commercial shipments to Canada as well as Taiwan will begin immediately.

The company's enlighten laser system is already cleared by FDA for tattoo removal and the treatment of benign pigmented lesions.

enlighten continues to demonstrate global appeal and has become a major revenue contributor, according to Cutera. The company is confident that the Canadian and Taiwanese clearances will meaningfully drive 2016 enlighten revenue.

CUTR closed Friday's trading at $10.84, down 0.55%.

Clovis Oncology Inc.'s (CLVS) New Drug Application for Rociletinib is set to be reviewed by the FDA's Oncologic Drugs Advisory Committee on April 12, 2016.

Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

The FDA's final decision on Rociletinib is set for June 28, 2016. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

CLVS closed Friday's trading at $18.97, up 1.99%.

As expected, Merck & Co. Inc.'s (MRK) Supplemental New Drug Applications for Zetia and Vytorin for the reduction of the risk of cardiovascular events in patients with coronary heart disease have been turned down by the FDA.

Zetia, approved by the FDA in 2002, and Vytorin, approved in 2012, are indicated for use along with a healthy diet to reduce elevated LDL cholesterol in patients with hyperlipidemia.

Last December, an FDA panel recommended against approving Zetia and Vytorin for reducing the risk of heart attacks and strokes in patients with coronary heart disease.

Sales of Zetia were $2.57 billion in 2012; $2.66 billion in 2013; $2.65 billion in 2014 and $2.53 billion in 2015. Vytorin logged in sales of $1.75 billion in 2012; $1.64 billion in 2013; $1.52 billion in 2014 and $1.25 billion in 2015.

Put simply, the sales of Zetia and Vytorin were down 5% and 17% in 2015 compared to 2014.

MRK closed Friday's trading at $49.03, up 0.37%.

Shares of Xenetic Biosciences Inc. (XBIO.OB) surged over 63% on Friday, as investors welcomed the news of OPKO Health Inc. (OPK) acquiring an approximate 6.3% interest in the company.

XENE closed Friday's trading at $0.36, up 63.56%.