Archive for the ‘Health Care Stocks’ Category

ResCare, Inc. (RSCR) – Buzz Stock of the Day

Monday, August 16th, 2010

Shares of home care services provider ResCare, Inc. (Nasdaq: RSCR) surged as much as 20 percent from Friday’s closing price in morning trading on Monday after it was announced that Toronto-based investment firm, Onex offered to buy approximately 75 percent of the common and preferred shares of Res-Care for $12.60 per share, which is a 24 percent premium over Friday’s closing price of $10.14 per share.

Affiliates of Onex currently hold 24.9 percent of the common and preferred shares of Louisville-based Res-Care.
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There currently are about 29 million shares outstanding.

ResCare recently reported second quarter profit of $8.1 million, or 28 cents per diluted common share, up from $7.1 million, or 25 cents per diluted common share in the same period a year ago. Second quarter revenue dipped 2 percent to $396.1 million, compared to revenue of $405.3 million for the same period in 2009. EBITDA for the second quarter of 2010 was $26.4 million versus $23.7 million in the prior year quarter.

ResCare confirmed its 2010 guidance issued on March 8, 2010, including revenues of approximately $1.6 billion and diluted earnings per common share in the range of $1.05 to $1.15.

Cypress Bioscience, Inc. (CYPB) – Buzz Stock of the Day

Monday, July 19th, 2010

Shares of drug maker Cypress Bioscience, Inc. (Nasdaq: CYPB) rallied as much as 41 percent from Friday’s closing price, in morning trading on Monday after hedge fund, Ramius offered to buy the company for about $154 million, or $4.00 a share in cash.

Ramius currently owns 9.9 percent of Cypress’ common stock. The offer of $4.00 per share is a 60 percent premium over Friday’s closing price of $2.50.

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In addition to the all-cash offer, Ramius also stated  that it would consider an acquisition structure that would allow management to continue the development of the recently acquired antipsychotic drug, BL-1020 if they are able to fund the required financing for the Phase IIb trial themselves or from a third party financing source.

In late June, Cypress Bioscience, Inc. entered  into an exclusive North American license for the development and commercialization of BioLineRx’s novel antipsychotic, BL-1020, a treatment for schizophrenia. Specific terms of the transaction were not disclosed, but the total upfront payment to BioLineRx was $30 million, with total potential clinical and regulatory milestones of up to $160 million through to approval in the United States, potential commercial milestones of $85 million, and a potential additional $90 million associated with approval for additional indications in the United States or for approval in other countries in North America. Cypress also agreed to fund all continuing development activities and pay BioLineRx a royalty based on applicable sales.

Ramius said poor decisions by Cypress management has damaged its stock price and that the company should hold off on making any further acquisitions or licensing deals. Shares of Cypress Bioscience are down about 73 percent over the past 12 months.

In a letter to Cypress management, Ramius said it is “ready, willing, and able to close this transaction expeditiously and expect the board to retain a reputable investment bank to immediately engage in discussions with us and any other potential acquirers to maximize value for all shareholders.”

Arena Pharmaceuticals, Inc. (ARNA) – Buzz Stock of the Day

Friday, July 16th, 2010

We first featured Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) on July 1, after the company announced a U.S. marketing deal for its obesity treatment, lorcaserin. Since then, shares have continued their climb, surging almost 20 percent in pre-market trading on Friday after it was announced that an FDA panel voted 9-7 against clearing a competing experimental weight loss drug developed by Vivus, Inc. for marketing in the U.S.

Panelists unanimously agreed the drug helps patients lose pounds, with most reporting more than 10 percent weight loss. But those benefits were outweighed by a slew of safety concerns that cropped up in company trials, including memory lapses, suicidal thoughts, heart palpitations and birth defects.

In contrast, Arena’s weight loss drug, lorcaserin is much safer, but hasn’t shown to shed pounds as much as Vivus’ drug, Qnexa. Lorcaserin is the most advanced candidate in Arena Pharmaceuticals’ pipeline. It is a member of a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor, the company said, is strongly associated with feeding behavior and satiety. The FDA is expected to act on Arena’s application to begin marketing lorcaserin by October 22.

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Shares of Orexigen Therapeutics (Nasdaq: OREX), whose diet drug Contrave is also up for approval, plummeted 12.6 percent to $4.37. Many industry experts believe that while Contrave is safer than Qnexa, its safety profile may not be as strong as Arena’s lorcaserin. Contrave combines the antidepressant Wellbutrin with a sustained-release version of an opioid blocker used to treat alcohol, drug, and other addictions. The company said a late-stage trial of Contrave in patients with type 2 diabetes showed that after 56 weeks of treatment, overweight or obese patients with the disease lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo. Orexigen is up for review in January.

ARNA was recently upgraded to Overweight from Neutral by JP Morgan, with a price objective increasing to $6 from $5. Arena Pharmaceuticals, was also downgraded to Market Underperform from Market Perform by Rodman & Renshaw on Friday morning. The R&R analyst put a paltry $1 price target on the stock, citing efficacy and safety concerns that could present “regulatory challenges” for the firm’s Lorcaserin diet drug.

The market research firm Datamonitor referred to obesity in a 2009 report as the “$11 billion market that never was” as it forecast drug sales in the category to reach just $560 million in 2018, far less that the $12.2 billion market opportunity it says is there. The problem, says Datamonitor, is that “current approaches just aren’t good enough to capitalize on this opportunity.”

Keryx Biopharmaceuticals, Inc. (KERX) – Hot Buzz Stock of the Day

Wednesday, July 14th, 2010

Shares of Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) climbed as much as 17 percent in morning trading Wednesday after the after the company announced its experimental childhood cancer drug, KRX-0401 (perifosine), had received Orphan Drug designation from U.S. Food and Drug Administration (FDA).

Commenting on receiving Orphan Drug designation, Ron Bentsur, Chief Executive Officer of Keryx stated, “We are currently exploring next steps for the development of perifosine in this indication which we hope, ultimately, could provide a new treatment option for children and infants suffering with neuroblastoma.

The FDA grants Orphan Drug status to new drugs that treat a rare disease afflicting fewer than 200,000 patients in the U.S. The benefits of Orphan Drug designation include seven-year marketing exclusivity if the drug is the first of its kind approved, tax credits for clinical research costs, the ability to apply for annual grant funding, clinical research trial design assistance and waiver of Prescription Drug User Fee Act (PDUFA) filing fees.

KRX-0401 is being developed for the treatment of neuroblastoma, a cancer of the nervous system affecting mostly children and infants. Although it is a rare form of cancer, neuroblastoma accounts for approximately 7 percent of all cancer deaths among children.

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Clinical Phase 1 data was presented last month in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Investigators from the Memorial Sloan-Kettering Cancer Center concluded that perifosine was demonstrated to be safe and well tolerated in children with advanced solid tumors and that perifosine may have antitumor clinical activity as a single agent in neuroblastoma.

Additionally, the Nationaly Cancer Institute recently published a preclinical study that found perifosine showed a statistically significant reduction in neuroblastoma cell survival, slowed or regressed tumor growth, and increased survival in mice bearing neuroblastoma tumors.

Vivus, Inc. (VVUS) – Buzz Stock of the Day

Tuesday, July 13th, 2010

Shares of weight loss drug maker, VIVUS, Inc. (Nasdaq: VVUS) surged as much as 13 percent from Monday’s closing price, in morning trading on Tuesday after the U.S. Food and Drug Administration released documents that showed FDA researchers believe that use of Vivus’ diet drug Qnexa can result in “significant” weight loss. However, the agency raised questions about the drug’s safety.

Vivus shares were up about 34% to $14.25 in Tuesday’s pre-market trading session.

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In the FDA’s review of Qnexa, posted online Tuesday as part of the briefing documents for Thursday’s advisory panel, pooled data from two large phase III studies demonstrated that patients treated with low, medium and high doses Qnexa lost between 3 percent, 7 percent and 9 percent of their body weight, respectively, adjusted for the weight-loss reported for patients treated with a placebo.

Qnexa’s safety and not the drug’s ability to help patients lose weight, was the major concern entering Thursday’s meeting. In its briefing document Tuesday, FDA’s safety review highlights five areas of “particular interest” related to Qnexa — pregnancy risk, psychiatric-related adverse events, cognitive-related adverse events, metabolic acidosis and cardiovascular events. Many of these concerns, however, were expected.

Vivus, in its own briefing documents, said research showing that 68 percent of adults in the U.S. are overweight indicate a clear medical need for Qnexa.

A panel of experts is scheduled to review the drug on Thursday, with the FDA making a regulatory decision in October.