Valeant Pharmaceuticals (VRX) Stock: Gaining On FDA Approval

Valeant Pharmaceuticals Intl Inc (NYSE: VRX) is having an overwhelmingly strong start to the trading session this morning in the pre-market hours, and for good reason. The company announced that its wholly owned subsidiary, Bausch + Lomb, in conjunction with Nicox S.A., has received FDA approval for a key treatment. Of course, this led to excitement among investors, sending the stock skyward and prompting our friends at Trade Ideas to send the alert. Below, we’ll talk about the approval, how the market reacted, and what we’ll be watching for with regard to VRX ahead.

VRX Announces FDA Approval

As mentioned above, Valeant Pharmaceuticals is having a relatively strong start tot he trading session in the pre-market after announcing that the FDA has approved a new treatment. The announcement actually came from the company’s wholly owned subsidiary, Bausch + Lomb, as well as their partners in the product, Nicox S.A.

In a press release, the company’s announced that the United States Food and Drug Administration has approved the New Drug Application for VYZULTATM. VYZULTA is the first ever prostaglandin analog with one of its metabolites being nitric oxide. The treatment was approved and indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Bausch + Lomb licensed VYZULTA from Nicox. The approval by the FDA is a key milestone, unlocking a milestone payment, in which Bausch + Lomb (VRX) will pay Nicox $17.5 million and Nicox will pay Pfizer (PFE) $15 million under a previous license agreement associated with the treatment. In a statement, Joseph C. Papa, CEO at VRX, had the following to offer:

With today’s approval of VYZULTA, our customers and their patients with glaucoma now have a new treatment option that can help provide consistent and sustained IOP lowering, the only modifiable risk factor that can help slow down the progression of the disease… We expect to make this new advancement available for those who suffer with glaucoma before the end of the year.”

The above statement was followed up by Michele Garufi, chairman and CEO at Nicox with the following:

VYZULTA represents the first FDA-approved therapy developed through our proprietary NO-donating research platform… We look forward to continuing to leverage our platform in the development of additional innovative ophthalmic compounds.”

How The Stock Is Reacting To The News

As we’ve come to expect any time a publicly traded pharmaceutical company announces an FDA approval, VRX is having an overwhelmingly strong start to the trading session this morning. At the moment (8:58), the stock is trading at $11.53 per share after a gain of $0.47 per share or 4.25% thus far today.

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What We’ll Be Watching For Ahead

Moving forward, the CNA Finance team will continue to keep a close eye on VRX. In particular, we’re interested in following the news surrounding VYZULTA and the company’s efforts to bring the treatment to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!

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