Valeant Pharmaceuticals Intl Inc: FDA Issues Complete Response Letter on Latanoprostene Bunod Ophthalmic Solution, 0.024% NDA


Valeant Pharmaceuticals Intl Inc (NYSE:VRX) announced it has received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension.

The CRL from the FDA only refers to a Current Good Manufacturing Practice (CGMP) inspection at Bausch + Lomb’s manufacturing facility in Tampa, Fla. The FDA 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 will work closely with the FDA to determine the appropriate next steps for the NDA.

Shares of Valeant are down nearly 1% to $15.20 in after-hours trading Monday. VRX has a 1-year high of $32.75 and a 1-year low of $8.31. The stock’s 50-day moving average is $16.55 and its 200-day moving average is $13.36.

On the ratings front, Valeant has been the subject of a number of recent research reports. In a report issued on August 4, Canaccord analyst Neil Maruoka reiterated a Hold rating on VRX, with a price target of $14, which represents a potential downside of 9% from where the stock is currently trading. Separately, on August 3, RBC’s Douglas Miehm assigned a Hold rating to the stock and has a price target of $21.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Neil Maruoka and Douglas Miehm have a yearly average loss of 1.8% and 8.1% respectively. Maruoka has a success rate of 37% and is ranked #3968 out of 4628 analysts, while Miehm has a success rate of 33% and is ranked #4399.

Overall, 3 research analysts have rated the stock with a Sell rating, 9 research analysts have assigned a Hold rating and 3 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 $19.00 which is 23.6% above where the stock opened today.

Valeant Pharmaceuticals International, Inc. engages in the development, manufacture, and market of a broad range of pharmaceutical products in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. It operates through the following segments: The Bausch + Lomb/International, The Branded Rx, and The U.S. Diversified products. The Bausch + Lomb/International segment is consist of the sale of pharmaceutical products, over-the-counter products, and medical devices products. The Branded Rx segment is comprised of pharmaceutical products related to the Salix product portfolio; dermatological product portfolio; branded pharmaceutical products, branded generic pharmaceutical products; over-the-counter products; medical device products; Bausch + Lomb products sold in Canada; and the oncology, dentistry, and health products for women. The U.S. Diversified Products segment is the sales in the U.S. of pharmaceutical products, over-the-counter products, and medical device products in the areas of neurology and certain other therapeutics classes, including aesthetics and generic products in the U.S.