Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced it has received a Complete Response Letter (CRL) from theU.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The concerns raised by the FDA pertain to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Florida where some deficiencies were identified by the FDA. The FDA’s letter did not identify any efficacy or safety concerns with respect to the NDA or additional clinical trials needed for the approval of the NDA for latanoprostene bunod ophthalmic solution, 0.024%.
Valeant intends to meet with the FDA as soon as possible to work on a resolution and address these concerns.(Original Source)
Shares of Valeant closed yesterday at $24.48, down $0.09 or -0.37%. VRX has a 1-year high of $263.81 and a 1-year low of $18.55. The stock’s 50-day moving average is $23.11 and its 200-day moving average is $47.79.
On the ratings front, Valeant has been the subject of a number of recent research reports. In a report issued on July 20, Wells Fargo analyst David Maris maintained a Sell rating on VRX, with a price target of $19.50, which reflects a potential downside of -20.3% from last closing price. Separately, on the same day, RBC’s Douglas Miehm maintained a Hold rating on the stock and has a price target of $33.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Maris and Douglas Miehm have a total average return of 7.3% and -10.6% respectively. Maris has a success rate of 70.5% and is ranked #580 out of 3996 analysts, while Miehm has a success rate of 42.1% and is ranked #3626.
The street is mostly Neutral on VRX stock. Out of 17 analysts who cover the stock, 9 suggest a Hold rating , 5 suggest a Buy and 3 recommend to Sell the stock. The 12-month average price target assigned to the stock is $33.90, which implies an upside of 38.5% from current levels.
Valeant Pharmaceuticals International, Inc. is a multinational specialty pharmaceutical company that develops manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, neurology, and branded generics. The company operates through two operating and reportable segments: (i) Developed Markets and (ii) Emerging Markets. The Developed Markets segment consists of (i) sales in the U.S. of pharmaceutical products, OTC products, and medical device products, as well as alliance and contract service revenues, in the areas of eye health, dermatology and podiatry, aesthetics and dentistry, (ii) sales in the U.S. of pharmaceutical products indicated for the treatment of neurological and other diseases, as well as alliance revenue from the licensing of various products it developed or acquired, and (iii) pharmaceutical products, OTC products, and medical device products sold in Canada, Australia, New Zealand, Western Europe and Japan. The Emerging Markets segment consists of branded generic pharmaceutical products and pharmaceuticals, OTC products, and medical device products. Products are sold primarily in Central and Eastern Europe (primarily Poland and Russia), Asia, Latin America (Mexico, Brazil, and Argentina and exports out of Mexico to other Latin American markets), Africa and the Middle East.