Valeant (VRX) Stock Higher Ahead of Anticipated FDA Approval

Valeant (VRX) stock is rising this afternoon ahead of tomorrow's PDUFA date for the new drug application of Relistor oral.
By Rachel Graf ,

NEW YORK (TheStreet) -- Shares of Valeant Pharmaceuticals (VRX) are gaining 4.33% to $23.85 in early-afternoon trading on Monday ahead of the FDA's July 19 Prescription Drug User Fee Act (PDUFA) date for the new drug application of Relistor oral in the treatment of opioid-induced constipation.

"Following the FDA's delay in PDUFA date, we remain confident that Oral Relistor should see approval in or around its PDUFA date," RBC Capital Markets wrote in a note last week.

Valeant has another upcoming PDUFA date on July 21 for the new drug application of Vesneo (lantanoprostene bunod) in the treatment of elevated intraocular pressure.

Vesneo could see a delay in its PDUFA date by three months, but should be approved by October, according to RBC.

Additionally, the Dermatologic andOphthalmic Drugs Advisory Committee (DODAC) is meeting on July 19 to review brodalumab (broda) in the treatment of moderate to severe plaque psoriasis in adults.

"As expected, the Agency has raised substantial concerns about the incidence of suicidality and major cardiovascular adverse events (MACE) witnessed in the clinical studies for broda, and a key reviewer has recommended an additional clinical study be conducted," Canaccord Genuity wrote in a note today. 

"We believe that broda has the potential to eventually become a significant contributor to Valeant's top line; however, a restrictive label would likely cap the upside for this drug, in our view," the firm added.

Separately, TheStreet Ratings team rates the stock as a "sell" with a ratings score of D.

Valeant's weaknesses include its deteriorating net income, generally high debt management risk, disappointing return on equity, generally disappointing historical performance in the stock itself and feeble growth in its earnings per share.

You can view the full analysis from the report here: VRX

TheStreet Ratings objectively rated this stock according to its "risk-adjusted" total return prospect over a 12-month investment horizon. Not based on the news in any given day, the rating may differ from Jim Cramer's view or that of this article's author. 

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