Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced that it has received notification from the U.S. Food and Drug Administration (FDA) that the Dermatologic and Ophthalmic Drugs Advisory Committee will review Valeant’s New Drug Application (NDA) for brodalumab on July 19, 2016.
On January 25, 2016, Valeant announced that the FDA had accepted for review the Biologics License Application (BLA) submitted by AstraZeneca (LSE/SSE/NYSE: AZN) in partnership with Valeant for brodalumab injection, 210 mg, a monoclonal antibody that targets the IL-17 receptor, in development for patients with moderate to severe plaque psoriasis. The FDA assigned a Prescription Drug User Fee Act (PDUFA) action date of November 16, 2016.
“Plaque psoriasis is a chronic disease of the immune system that can impair many aspects of patients’ lives,” said Joseph C. Papa, chairman and chief executive officer. “We look forward to the opportunity to discuss brodalumab treatment options for adult patients with moderate to severe plaque psoriasis and provide information about this novel antibody we are developing.”
As previously announced, the Marketing Authorisation Application (MAA) for brodalumab in psoriasis was accepted by the European Medicines Agency (EMA) in Q42015. In October, 2015, Valeant entered into a collaboration agreement with AstraZeneca under which Valeant has an exclusive license to develop and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa Hakko Kirin Co., Ltd. (Original Source)
Shares of Valeant are down nearly 2% to $24.90 in pre-market trading. VRX has a 1-year high of $263.81 and a 1-year low of $22.52. The stock’s 50-day moving average is $29.63 and its 200-day moving average is $63.43.
On the ratings front, Valeant has been the subject of a number of recent research reports. In a report released yesterday, Morgan Stanley analyst David Risinger maintained a Hold rating on VRX, with a price target of $36, which implies an upside of 41.3% from current levels. Separately, on the same day, Stifel Nicolaus’ Annabel Samimy maintained a Buy rating on the stock and has a price target of $55.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, David Risinger and Annabel Samimy have a total average return of 1.6% and 12.2% respectively. Risinger has a success rate of 65% and is ranked #1510 out of 3903 analysts, while Samimy has a success rate of 58% and is ranked #356.
Overall, 4 research analysts have rated the stock with a Sell rating, 10 research analysts have assigned a Hold rating and 7 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $34.58 which is 35.7% above where the stock closed yesterday.
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. Valeant Pharmaceuticals was founded on March 29, 1994 and is headquartered in Laval, Canada.