Biotechs With Upcoming PDUFA Dates

On Tuesday, the FDA approved only the second weight-loss drug in the last 13 years when it green-lighted Vivus' drug Qsymia. On Wednesday, VVUS shares have shot up more than 14% to $30.27. The approval of this drug and the attendant excitement that it has created in the biotech investing community may continue to drive the red-hot sector higher. Year-to-date, the SPDR S&P Biotech ETF XBI has climbed more than 41%, making it the strongest area of the market in 2012. The XBI is currently sitting at 52-week highs and could continue to surge on the back of more FDA approvals and biotech buyouts. With this idea in mind, Benzinga is highlighting a number of companies that have upcoming FDA approval dates. Below, we outline ten biotech names that have drug PDUFA dates in the next two months. Horizon Pharma HZNP - This company's drug LODOTRA has a PDUFA date on July 26. The drug is used to treat rheumatoid arthritis in adults. The stock has run up into this highly anticipated decision and has gained almost 137% over the last 6 months. Look for the shares to continue to be active in the coming days ahead of the key decision on July 26. Amarin AMRN - This company's PDUFA date is on July 26 as well. The company's drug candidate is called AMR101, and is indicated for the treatment of very high triglycerides. If Amarin were to receive approval of this product, the stock very well could be an attractive buyout candidate for a big pharmaceutical company. Shares have been soaring going into this key decision. Year-to-date, AMRN is up more than 100% and is currently sitting close to new highs. Look for this name to be volatile into the July 26 PDUFA date. Salix Pharmaceuticals SLXP - Salix's drug candidate is called RELISTOR and is indicated for opioid-induced constipation in patients with non-cancer pain. The PDUFA date is coming up on July 27. SLXP shares have been rising as the date draws nearer, but have come off of their highs seen in early July. Year-to-date, SLXP has added a little better than 9%. Onyx Pharmaceuticals ONXX - This company's drug candidate known as Kyprolis has received an 11-0 positive vote from an FDA advisory panel and its PDUFA date is set for July 27. The FDA does not have to follow the committee's recommendations. Kyprolis is indicated for the treatment of relapsed and refractory multiple myeloma. In the wake of the advisory panel vote, ONXX shares have soared. Year-to-date, the stock has climbed more than 55% and could continue higher if Kyprolis gains approval. Regeneron Pharmaceuticals REGN - This company already has two marketed products and will try to make it three with its August 12 PDUFA date for Zaltrap. The drug is for the treatment of metastatic colorectal cancer. Regeneron recently began marketing a drug called EYLEA for wet age-related macular degeneration. The approval and subsequent launch of this drug has helped the stock rise almost 125% year-to-date. An approval for Zaltrap could provide an additional catalyst for the stock. Talon Therapeutics TLON - This is a very small biotech company which trades OTC. Talon only has a market cap of $28 million. The company has an upcoming PDUFA date on August 12 for a drug called Marqibo which is indicated for adult Philadelphia chomosome-negative acute lymphoblastic leukemia. Year-to-date, the shares have soared more than 213% as investors gear up for the pivotal FDA decision. Salix Pharmaceuticals SLXP - This is the second time that Salix makes it on this list. In addition to the company's July PDUFA date for RELISTOR, a Salix drug called Provir will face FDA approval on September 5. The drug is used for control and symptomatic relief of diarrhea in patients with HIV/AIDS on anti-retroviral therapy. Ironwood Pharmaceuticals IRWD - Ironwood has a PDUFA date on September 9 for a product called Linaclotide. The drug is indicated for irritable bowel syndrome with constipation and chronic constipation. in 2012, IRWD shares have added a little less than 13%. The company has a market cap of $1.44 billion at current levels. Navidea Biopharmaceuticals NAVB - This company's drug candidate is called Lymphoseek and is scheduled for FDA approval on September 10. The product is used for intraoperative lymphatic mapping. The stock has surged in recent months on anticipation of this PDUFA date. At the beginning of June, NAVB was trading at around $2.70, which compares to the stock's current price of $4.41. NPS Pharmaceuticals NPSP - This company's drug candidate has its PDUFA date set for September 30. The company's product is called Gattex and is indicated for the treatment of adult short bowel syndrome. NPSP shares are sitting near their highs for 2012 and could continue to run into this key FDA approval decision. Year-to-date, NPSP has added better than 33%.