Market Overview

Biotechs With Upcoming PDUFA Dates


On Tuesday, the FDA approved 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 percent to $30.27. The approval of this drug and the 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 (NYSE: XBI) has climbed more than 41 percent, 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. Here are ten biotech names that have drug PDUFA dates in the next two months:

Horizon Pharma (NASDAQ: HZNP) - This company's drug LODOTRA (used to treat rheumatoid arthritis in adults) has a PDUFA date on July 26. The stock has run up into this highly anticipated decision and gained almost 137 percent over the last 6 months. Look for the shares to continue to be active in the coming days ahead of the decision on July 26.

Amarin (NASDAQ: AMRN) - This company's PDUFA date is July 26 as well. The company's drug candidate is called AMR101, indicated for the treatment of very high triglycerides. If Amarin were to receive approval of this product, the stock 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 percent and is currently sitting close to new highs. Look for this name to be volatile into the July 26 PDUFA date.

Salix Pharmaceuticals (NASDAQ: SLXP) - Salix's drug candidate is called RELISTOR and is intended for opioid-induced constipation in patients with non-cancer pain. The PDUFA date is 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 percent.

Onyx Pharmaceuticals (NASDAQ: 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 percent and could continue higher if Kyprolis gains approval.

Regeneron Pharmaceuticals (NASDAQ: 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 percent year-to-date. An approval for Zaltrap could provide an additional catalyst for the stock.

Talon Therapeutics (OTC: 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 percent as investors gear up for the pivotal FDA decision.

Salix Pharmaceuticals (NASDAQ: 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 (NASDAQ: IRWD) - Ironwood has a PDUFA date on September 9 for a product called Linaclotide. The drug is indicated for irritable bowel syndrome and chronic constipation. in 2012, IRWD shares have added a little less than 13 percent. The company has a market cap of $1.44 billion at current levels.

Navidea Biopharmaceuticals (NYSE: 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 (NASDAQ: 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 percent.

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