2012 is so far the best year for the Biotechnology and Drugs industry. So many stocks surged in the last three months based on clinical trial results, U.S. Food and Drug Administration (FDA) approval, FDA Advisory Committee's recommendation, European commission approval, recommendation from independent committees, partnership with big pharmaceuticals, acquisitions and so on. Below is the list of four biotechnology companies that has huge upside or downside potential in the month of April.
Biotech stocks are high risk-reward stocks and hence considerable analysis is required before trading. Use this list as a potential starting point for your analysis.
VIVUS Inc (VVUS) - Key Dates: April 17, 2012 & April 29, 2012
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company's lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators.
VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. VIVUS resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012.
On February 22, 2012, VIVUS announced that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended Qnexa be granted marketing approval by the FDA for the treatment of obesity in adults. The Committee voted 20 to 2, on the recommendation for an approval based on a favorable benefit-risk profile.
Furiex Pharmaceuticals Inc (FURX) - Key Date: April 25, 2012
Furiex Pharmaceuticals, Inc. is a drug development collaboration company. The Company's product pipeline includes two marketed products and three programs in development, including late-stage compounds, in multiple therapeutic areas. Its programs include Priligy, Alogliptin Nesina, Alogliptin/Actose Combination, Alogliptin/Metformin Combination, Fluoroquinolone, Mu Delta and PPD 10558. Priligy (dapoxetine) is a drug developed for the on-demand treatment of premature ejaculation (NYSE:PE). Dapoxetine is a short-acting, selective serotonin reuptake inhibitor (NASDAQ:SSRI) designed to be taken only when needed one to three hours before sexual intercourse is anticipated rather than every day. Nesina (alogliptin) is a drug for the oral treatment of type 2 diabetes (T2D).
Nesina® (alogliptin) is a member of a new class of drugs for the oral treatment of type 2 diabetes (T2D). Nesina is being developed and marketed by Takeda Pharmaceuticals. In April 2010, Takeda received regulatory approval from Japan's Ministry of Health, Labour and Welfare for Nesina and it is now being sold in Japan.
Takeda has resubmitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA), and the Prescription User Fee Act (PDUFA) action date has been set for April 25, 2012
Furiex is currently trading around $24.19 with a 52-week range of $12.25 to $25. If FDA approves Nesina, Furiex share price will rally and set new 52-week high because it will receive a $25 million dollar payment, and also up to 12% royalties on future US sales.
On January 31, 2012, Furiex announced that the European Commission endorsed the positive opinion adopted by the Committee for Human Medicinal Products (OTCQB:CHMP) on October 18, 2011 for Priligy™ (dapoxetine) 30 mg and 60 mg doses. Pending national approvals, the marketing authorization for the Priligy doses can be granted in the European Union Member States where the drug has not yet been approved, and also in Norway and Iceland.
Progenics Pharmaceuticals, Inc. (PGNX) - Key Date: April 27, 2012
Progenics Pharmaceuticals, Inc. (Progenics) is a biopharmaceutical company focusing on the development and commercialization of therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. The Company is also engaged in research to identify multiplex phosphoinositide 3-kinase (PI3K) inhibitors for blocking signaling pathways in the growth of aggressive cancers. All of the Company's operations are conducted at its facilities in Tarrytown, New York. In gastroenterology, its first commercial product is RELISTOR (methylnaltrexone bromide) subcutaneous injection, a first-in-class therapy for opioid-induced constipation approved for sale in over 50 countries worldwide, including the United States, the European Union, Canada and Australia. Marketing applications are pending elsewhere worldwide.
A supplemental New Drug Application (SNDA) for subcutaneous RELISTOR in non-cancer pain patients has an action date under the U.S. Prescription Drug User Fee Act (PDUFA) of April 27, 2012. RELISTOR is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain. RELISTOR Subcutaneous Injection has been FDA approved since 2008 to treat OIC in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. Use of RELISTOR beyond four months has not been studied. RELISTOR is under license to Salix from Progenics Pharmaceuticals, Inc.
Salix Pharmaceuticals, Ltd. (SLXP) - Key Date: April 27, 2012
Salix Pharmaceuticals, Ltd. is a specialty pharmaceutical company engaged in acquiring, developing and commercializing prescription drugs and medical devices used in the treatment of a variety of gastrointestinal diseases, which are those affecting the digestive tract. As of December 31, 2011, the Company's products included XIFAXAN, MOVIPREP, RELISTOR, OSMOPREP, VISICOL, APRISO, SOLESTA, DEFLUX, METOZOLV ODT, AZASAN, ANUSOL-HC, PROCTOCORT Cream, PEPCID, Oral Suspension DIURIL and COLAZAL. As of December 31, 2011, its primary product candidates under development included Rifaximin, Crofelemer, Balsalazide disodium tablet, Budesonide foam, Methylnaltrexone bromide and Methylnaltrexone bromide oral.
Salix is currently trading around $52.92 with a 52-week range of $25.64 to $53.99. On February 28, 2012, Auriga raises its rating on Salix Pharmaceuticals to Buy and raises its price target to $54 on more robust growth of Xifaxan. A supplemental New Drug Application for subcutaneous RELISTOR in non-cancer pain patients has an action date under the U.S. Prescription Drug User Fee Act (PDUFA) of April 27, 2012. Progenics has exclusively licensed development and commercialization rights of RELISTOR, to Salix Pharmaceuticals, Ltd. for markets worldwide other than Japan, where Ono Pharmaceutical Co., Ltd. holds an exclusive license for the subcutaneous formulation.
U.S. Food and Drug Administration has also granted Priority Review designation for the Company's New Drug Application for crofelemer 125 mg tablets for the proposed indication for the control and symptomatic relief of diarrhea in patients with human immunodeficiency virus (HIV)/acquired immune deficiency syndrome (AIDS) on anti-retroviral therapy (ART). Based on this review classification, the FDA has issued an action date for the NDA of June 5, 2012 under the Prescription Drug User Fee Act (PDUFA).
Disclaimer: Some data is sourced from Google Finance and investors site. I am not a registered investment advisor and do not provide specific investment advice. The information contained herein is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. It is up to the investor to make the correct decision after necessary research
Disclosure: I am long VVUS.