Valeant Pharmaceuticals Intl Inc (VRX) Subsidiary Salix Receives Notification of PDUFA Date Extension


Salix Pharmaceuticals, a wholly owned subsidiary of Valeant Pharmaceuticals Intl Inc (NYSE:VRX), announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for PLENVU, a novel, lower-volume polyethylene glycol based bowel preparation that has been developed to help provide complete bowel cleansing, with an additional focus on the ascending colon. The PDUFA date has been extended by the standard extension period of three months to May 13, 2018.

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As high preparation volumes can often be a deterrent in patients fully completing their regimen, PLENVU®, when approved, will offer the lowest total volume of solution for an FDA-approved bowel cleanser in the market.

Colorectal cancer is the third leading cause of cancer-related deaths in women in the United States and the second leading cause in men, and successful colorectal cancer screening can save lives.1

PLENVU® was licensed by Salix from Norgine in August 2016 for introduction to the U.S. market. Salix and Norgine will continue to work closely with the FDA to support the review of PLENVU®, a next-generation bowel cleansing preparation for colonoscopies.

On the ratings front, Valeant stock has been the subject of a number of recent research reports. In a report issued on January 24, Goldman Sachs analyst Dana Flanders initiated coverage with a Sell rating on VRX and a price target of $18, which represents a slight upside potential from current levels. Similarly, Piper Jaffray’s David Amsellem maintained a Sell rating on the stock and has a price target of $12.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Dana Flanders and David Amsellem have a yearly average loss of 3.1% and 4.4% respectively. Flanders has a success rate of 54% and is ranked #3666 out of 4722 analysts, while Amsellem has a success rate of 42% and is ranked #4439.

Overall, 4 healthcare analysts have rated VRX with a Sell rating, 4 have assigned a Hold, and 2 analysts have given a Buy rating for the stock. When considering if perhaps the stock is under or overvalued, the average price target is $17.00 which is 3.2% under where the stock opened today.