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June Catalysts for Biotech and Drug Stocks


Bristol-Myers, Pfizer, others mark a busy FDA calendar. Two major medical meetings make for a lot of stock movement in June.

June is a busy month for US Food and Drug Administration decisions on experimental medicines. Several companies are taking another stab at getting their products approved after initial rejections.

There are also two major medical conferences this month that may have a bearing on investor sentiment toward new treatments. That adds up to a lot of activity among drug and biotech stocks.

The calendar below highlights some of the month's events. Dates are subject to change. Post a comment below to share your thoughts on the month's biggest catalysts.

June 3
Orexigen Therapeutics (OREX) will hold a call to update investors on its effort to get diet pill Contrave approved in the US. The FDA rejected the drug in Februrary on safety concerns. (See Minyanville: Orexigen Nose Dives on Shock Diet Pill Rejection)

June 3 - 7
The American Society of Clinical Oncology holds its annual meeting in Chicago. Thousands of scientific papers on cancer drug research will be presented. (See Minyanville: Vical, Exelixis Surge as Cancer Meeting Nears and Five Cancer Drug Stocks to Buy)

Cell Therapeutics (CTIC) is supposed to meet with FDA officials in early June after the agency rejected the drug pixantrone for a form of non-Hodgkin's lymphoma.

June 9-12
European Hematology Association holds its meeting in London. The conference will feature presentations by major pharmaceutical makers as well as smaller companies such as Micromet (MITI), which will be showing data from its lead product candidate blinatumomab for blood cancer.

June 14
Valeant Pharmaceuticals (VRX) and GlaxoSmithKline (GSK) expect word from the FDA on appproval of Potiga for partial seizures due to epilepsy. The FDA rejected the drug in December even though a panel of expert advisers voted 13-0 in August to recommend approving the treatment. (See Minyanville: Betting Wrong on the FDA)

June 15
The FDA is expected to decide whether Bristol-Myers Squibb's (BMY) belatacept for kidney transplant rejection should be approved for sale in the US. The FDA turned down the drug's application in May of last year.

June 17
Acura Pharmaceuticals (ACUR) and Pfizer (PFE) expect to hear from the US Food and Drug Administration on approval of the powerful pain drug Acurox. The pain killer is designed to deter abuse but the drug was rejected in 2009. A panel of government experts last year reviewed the drug again and recommended it not be approved. That prompted the companies to revise Acurox.

On the same day, Regeneron Pharmaceuticals (REGN) faces an FDA advisory panel for VEGF Trap-Eye to treat the disorder age-related macular degeneration.

June 20
Salix Pharmaceuticals (SLXP) is scheduled to meet with the FDA after the agency rejected Xifaxan for irritable bowel syndrome. (See Minyanville: Salix Tanks After Drug Setback)

June 22
Fibrocell Science (FCSC) is expecting an FDA decision on its anti-wrinkle treatment LaViv.

June 23
Pain Therapeutics (PTIE), Durect (DRRX) and Pfizer await an FDA decision on Remoxy for moderate to severe chronic pain. Remoxy is designed to be another tamper-proof pain killer.

June 30
Dendreon (DNDN) should hear from the FDA on its plans to expand production of prostate cancer vaccine Provenge to a plant in Orange County, California.
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