Homebuilders LEN, KBH, TOL Up With Fed Holding RateStocks moved higher today after several positive reports reversed early downward trading trends. Investors initially drove down stocks on news that first time unemployment claims increased by 15,000 last week. Gains were made in homebuilders like Lennar (NYSE:LEN), KB Homes (NYSE:KBH), and Toll Brothers (NYSE:TOL) as well as retailers like Bed Bath & Beyond (Nasdaq:BBBY), Kirkland's (Nasdaq:KIRK), and Pier One (NYSE:PIR). Both sectors have seen bankruptcies (Linens and Things, Circuit City, among others) and layoffs over the past year as the souring economy has brought housing starts to a crawl and forced consumers to pull back in discretionary spending. Small-cap stocks in the Russell 2000 helped propel that index 2.87% to close at 509.14 today. Leading small-cap gainer was Jazz Pharmaceuticals (Nasdaq:JAZZ) up 37% on news that the late-stage results for its fibromyalgia drug had met the company's main goal. The drug, Xyrem, is scheduled to be submitted for marketing approval. Gains in Jazz shares outpaced gains made by other, better known, pharmaceutical manufacturers including Pfizer (NYSE:PFE), Merck (NYSE:MRK), and share price losses posted by GlaxoSmithKline (NYSE:GSK). As we've mentioned in previous updates, this follows a general trend of sector rotation as investors are looking for more defensive plays, like healthcare and pharma, over the summer. Other small-cap gainers for today include CPI International (Nasdaq:CPII) up 32%; Tween Brands (NYSE:TWB) up 27% on news that Dress Barn (Nasdaq:DBRN) will buy it for roughly $157 million in stock; Royale Energy (Nasdaq:ROYL) up 32.5%, an energy company involved in development and exploration of natural gas and oil in California, Texas, and the Rocky Mountain region. Small-cap decliners were lead by medical oral diagnostics maker OraSure Technologies (Nasdaq:OSUR) down 23% on news that it needs to conduct more additional clinical trials to get approval for its hepatitis C virus test. The exact timing and costs for these additional tests have not been disclosed by OraSure and investors drove down share prices based on this uncertainty. A number full of other small-cap stocks were big decliners today including data marketing services provider Acxiom Corporation (Nasdaq:ACXM) down 22%; Capital Bank Corporation (Nasdaq:CBKN) down 20%; and Cordorus Valley Bancorp (Nasdaq:CVLY) down 19%.
Celldex Therapeutics receives $10M milestone paymentCelldex Therapeutics, Inc. (Nasdaq:CLDX) said today that it received a $10 million milestone payment from an affiliate of Paul Capital Healthcare. The payment was triggered by the market launch of Rotarix in the United States, which is marketed worldwide by GlaxoSmithKline (NYSE:GSK). Shares were halted ahead of the opening bell. For detailed price information and news stories on Celldex Therapeutics, click CLDX.
Healthy outlook for Sinovac BiotechWhile it's well known that international corporate giants are funneling big bucks into research institutes in China, lesser known is the Chinese government's efforts to make the nation a world leader in medicine, science and technology. Examples of its push to beef up innovation can be seen at state-run research labs such as the China Academy of Sciences, a broad collection of R&D facilities currently undergoing significant reforms and expansion that officials hope will become a major high-tech incubator. The Academy already has a leadership role in the field of biotech. One of the Academy's partners in China's race to innovate in the biotechnology industry is Sinovac Biotech Ltd. (AMEX:SVA). Sinovac researchers have worked closely with government scientists to tackle illnesses (such as the outbreak of bird flu in Hong Kong). The company does business under its majority-owned subsidiary, Sinovac Beijing, and its wholly owned subsidiary, Tangshan Yian. A leading domestic vaccine producer, the biopharmaceutical company is engaged in the research, development and commercialization of agents that protect against human infectious diseases including hepatitis, influenza and SARS. Sinovac's portfolio of State Food and Drug Administration-approved products consists of Healive, a vaccine against hepatitis A virus; Bilive, which is used to prevent infection from hepatitis A and B; and Anflu, a seasonal influenza virus vaccine. Four pipeline drugs are also in development. They include two vaccine candidates for the H5N1 strain of bird flu (pandemic influenza) as well as a vaccine for the Japanese encephalitis virus, and another for SARS (Severe Acute Respiratory Syndrome), a potentially deadly virus with flu-like symptoms that attacks the lungs. Compared with Big Pharma drugs designed to battle cancer, high blood pressure, depression and high levels of bad cholesterol, pharmaceuticals such as those produced by Sinvac maintain a decidedly lower profile. But the vaccine maker doesn't seem to mind, especially given growing concerns about the threats posed by hepatitis, Avian flu, SARS and drug-resistant new viruses. After all, in the aftermath of the 7.9 magnitude earthquake that rocked China on May 12, business was a good for Sinovac, as provincial CDCs stocked up on vaccines to inoculate children against possible outbreaks of hepatitis A and B. Immediately after the disaster, China's Ministry of Health purchased $2.86 million worth . . .
Adolor pops in pre-market on FDA approvalShares of Adolor Corp. (Nasdaq:ADLR) are gaining ground in pre-market trading after the biopharmaceutical company in conjunction with GlaxoSmithKline (NYSE:GSK) said after Tuesday’s close that the U.S. Food and Drug Administration has approved the firms’ Entereg capsules to help patients regain gastrointestinal function earlier following bowel resection surgery. Postoperative ileus is a condition that affects almost all patients undergoing this type of surgery and can cause significant discomfort in addition to prolonging hospital stays for patients. Shares of Adolor gained 14%, or $0.73, to $6.10 in pre-market trading. For detailed price information and recent news stories about Adolor, click ADLR. Postoperative ileus is a condition that affects almost all patients undergoing this type of surgery and can cause significant discomfort in addition to prolonging hospital stays for patients. Shares of Adolor gained 14%, or $0.73, to $6.10 in pre-market trading. For detailed price information and recent news stories about Adolor, click ADLR.
Russell closes in the greenStocks managed to eek out gains for the first day after two straight sessions of red, as investors shrugged off Ambac Financial Group Inc.'s (NYSE:ABK) lackluster outlook and embraced better-than-expected results from a range of technology companies. The Russell 2000 (NYSE:IWM) ended the day up 4.40 points, or 0.66%, to a level of 708.11, while the Dow gained 42.99 points, or 0.34%, to a level of 12763.22. Trading was choppy for the day as investors digested a slew of earnings news from technology, industrial, tobacco, banks and commodity producers. A large percentage advance was registered early today in Sirtris Pharmaceuticals (Nasdaq:SIRT), with the stock up a whopping 82% on news that GlaxoSmithKline (NYSE:GSK) would buy the company for $720 million . . .
Russell 2000 edges upSmall-cap stocks are slightly higher after fluctuating during morning trading. At 11:37 a.m. ET, the Russell 2000 (NYSE:IWM) was up 5.1, or 0.72%, at 708.81, as the market trimmed away opening gains in choppy action. A large percentage advance was registered early today in Sirtris Pharmaceuticals (Nasdaq:SIRT), with the stock up a whopping 82% on heavy volume on news that GlaxoSmithKline (NYSE:GSK) would but the company for $720 million in cash. ANADIGICS Inc. (Nasdaq:ANAD) was up 24% following earnings results yesterday, and Silicon Graphics (Nasdaq:SGIC) was up about 23% after a heavy sell-off on Tuesday. On the downside, Daktronics (Nasdaq:DAKT) was down 23% after sloppy earnings. Buckeye Technologies Inc. (NYSE:BKI) was down 22% after the maker of cellulose-based specialty products cut its third-quarter earnings forecast to below Wall Street expectations. Rimage Corp. (Nasdaq:RIMG) was down 21% after releasing . . .
Small caps open modestlySmall-cap stocks opened modestly higher after a see-saw overnight session. At 9:56 a.m. ET, the Russell 2000 (NYSE:IWM) was down 0.26, or 0.04%, at 703.45, as the market trimmed away opening gains in choppy action. Stability in the foreign exchange market, a decent batch of overnight earnings and mild short profit-taking provided mild support for stocks but the market appeared to be searching for a more dynamic directional bias this morning. The U.S. dollar was up modestly at the beginning of U.S. trading and crude oil was down a couple bucks off Tuesday’s record high, which may have prompted a mild sigh of relief that the moves weren’t immediately extended. Still, the issue of a sluggish economy, coupled with rising food and energy costs, remains a major roadblock for equity market bulls. A USA Today poll said that rising food costs were a “significant” worry for Americans, with 73% of respondents citing higher grocery bills as a concern. The market has seen quite a bit of daily volatility in recent days, with percentage moves in the 2% or more range every other day for six sessions. If that pattern holds true today, then this will be the “quiet” day on the rollercoaster ride. From a charting standpoint, the Russell has support today near 700, 695 and then a window . . .
Sirtris Pharmaceuticals soars on buyout by GlaxoShares of Sirtris Pharmaceuticals Inc.(Nasdaq:SIRT) are rocketing in pre-market trading after the biopharmaceutical company said after Tuesday’s close that it will be acquired by healthcare goliath GlaxoSmithKline (NYSE:GSK) for approximately $720 million through a cash tender offer of $22.50 per share. Shares soared 82%, or $9.98, to $22.21 in pre-market trading. For detailed price information and recent news stories about Sirtris Pharmaceuticals, click SIRT.
Pozen and Glaxo score FDA approval for migraine treatment drugShares of Pozen Inc. (Nasdaq:POZN) are rocketing this morning after the small cap pharmaceutical company said that it, along with GlaxoSmithKline (NYSE:GSK), has received approval from the Food and Drug Administration for Treximet, a tablet that treats migraine attacks with or without aura in adults. Shares rocketed 39%, or $4.12, to $14.65 in pre-market trading. For detailed price information and recent news stories about Pozen, click POZN.
Check on China: 3SBio Inc.After a spate of food, drug and product safety recalls from China has left the nation's reputation in tatters among trading partners, one might think all the negative publicity would have shaken confidence in the country's pharma industry. It hasn't. To allay Western concerns, Beijing, which wants a healthy pharmaceutical industry, has pledged $1.2 billion to clean up its food and drug safety problems. China's State Food and Drug Administration, which has a regulatory system similar to the U.S. Food and Drug Administration, is being reformed to improve safety standards and crack down on corrupt practices and drug counterfeiters (the Chinese media has reported the agency has yanked hundreds of manufacturing licenses and stepped up facility inspections). Lower costs, top scientific talent and access to one of the world's largest and fastest-growing markets for prescription drugs have led every Big Pharma company—including Pfizer Inc. (NYSE: PFE), GlaxoSmithKline (NYSE: GSK), Bristol-Myers Squibb Co. (NYSE: BMY), Sanofi-Aventis (NYSE: SNY), Britain's AstraZeneca (NYSE: AZN) and Switzerland's Novartis (NYSE: NVS)—to set up shop in China. But international heavyweights aren't the only ones vying to tap China's rich drug market. In one niche in the bio-drug sector, a local player dominates rivals. 3SBio Inc. (Nasdaq: SSRX), a leading producer of high-quality, low-cost biopharmaceuticals, has cornered the market in China for the biologic drug Epoetin, known as Epo, which is used to treat anemia associated with chemotherapy and kidney dialysis by increasing production of red blood cells. Similar to Amgen Inc.'s (Nasdaq: AMGN) wildly popular Eopgen, 3SBio's flagship Epo product, sold under the brand name Epiao, makes up 37% of the Chinese market in product sales. (Amgen's product, distributed in China under the name Espo, has 15% market share; Swiss pharmaceutical company Roche's Epo drug, Recormon, has 10%.) Epogen sales, which are growing 30% annually, account for about 70% of 3SBio's total revenue. Tpiao, 3SBio's second best-selling product, is used to treat platelet deficiency, a side effect of chemotherapy treatment. Since its January 2006 launch, the drug has sold unchallenged with no known competition in China. Analyst Kimberly Lee of Pacific Growth Equities estimates the drug will rake in $4.8 million in fiscal 2007 and could see sales grow in the neighborhood of $29 million in five years.
Synta Pharmaceuticals to collaborate with GlaxoSmithKlineSynta Pharmaceuticals Corp. (Nasdaq: SNTA) said this morning that it will collaborate with GlaxoSmithKline (NYSE: GSK) to develop and commercialize STA-4783, a small-molecule, oxidative stress inducer that is entering Phase 3 clinical development for the treatment of metastatic melanoma. Under the terms of the agreement, the companies will share responsibility for development and commercialization of STA-4783 in the United States and GlaxoSmithKline will have exclusive responsibility for development and commercialization of STA-4783 outside the United States. Synta will receive an upfront cash payment of $80 million and will also be eligible to receive potential milestone payments of up to $135 million for events leading to approval of STA-4783 in metastatic melanoma, further development. It will also be eligible for regulatory milestones of up to $450 million across various indications and up to $300 million in potential commercial milestone payments based on achieving certain net sales thresholds. The agreement is subject to antitrust clearance by the U.S. government under the Hart-Scott-Rodino Act. Shares of Synta Pharmaceuticals (SNTA) slid 5.37%, or $0.55, to $9.70 out of the gate. Shares of Synta Pharmaceuticals have been trading in the range of $4.93 to $11.25 for the past 52 weeks.
Adolor: FDA accepts new drug application letterBiopharmaceutical company Adolor Corp. (Nasdaq: ADLR) announced in conjunction with GlaxoSmithKline plc (NYSE: GSK) that the U.S. Food and Drug Administration has accepted Adolor’s response to the November 2006 new drug application approvable letter for Entereg (alvimopan) for the management of postoperative ileus. Adolor said in a release that the FDA considers a complete class 2 response with a prescription drug user fee act goal date of Feb.10, 2008. "We are very pleased that the FDA has accepted for review the complete response for POI," Adolor CEO Michael Dougherty said in a release. "We remain committed to our goal of bringing this novel treatment to patients and surgeons and look forward to working with the FDA throughout the review." Adolor and GSK also submitted responses to the FDA requesting a release of the clinical holds for all alvimopan investigational new drug applications. The complete responses were received by the FDA on August 13. A release of the clinical holds by the FDA is needed for the two companies to restart any clinical development activities. Out of the gate, Adolor shares are soaring 19.1%, or $0.68, at $4.24. Over the last 52 weeks, shares have ranged between $3.09 and $25.26.
Epix Pharmaceuticals, Inc. identifies three lead candidates with GlaxoShares of Epix Pharmaceuticals, Inc. (Nasdaq: EPIX) are edging higher in pre-market trading this morning after the biopharmaceutical company said that through the company’s collaboration with GlaxoSmithKline (NYSE:GSK) it has identified three lead candidates that will move forward into lead optimization in this first collaborative G-protein coupled receptor discovery program. Epix said that under the collaboration, it is entitled to receive a $3 million milestone payment from Glaxo in the next 30 days. Shares of Epix gained $0.11, or 2.68%, to $4.22 in pre-market trading.
The skinny on eDiets.com
At first glance, eDiets.com Inc. (Nasdaq: DIET), an $88 million online diet and healthy lifestyle company, appears superbly positioned to capitalize on the trend of trying to lose weight using innovative diet programs in the digital age.
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After all, there’s no shortage of potential customers: roughly two-thirds of Americans are overweight (30% of U.S. adults, or some 60 million people, are categorized as obese). At any given time, about a third of the U.S. population—over 70 million individuals—are on diets of one form or another. The company has aggressively pursued Internet advertising and other traffic-generating methodologies, such as Web-based publications and video programs. Among its offerings: a dozen eNewsletters, an online magazine, Glee, which has articles by health, fitness and nutrition experts, and a library of videos featuring healthy food recipes. The company has also begun a push to pursue corporate licensing opportunities with its content and technology. One thorn in the company's side is the fact that competition from large players with substantial marketing firepower like weight management company Jenny Craig, Weight Watchers International, Inc. (NYSE: WTW), NutriSystem Inc. (Nasdaq: NTRI) and Herbalife Ltd. (NYSE: HLF) is intensifying as these companies find more innovative ways to add to increase their revenues.
Targacept Inc. jumps on deal with GlaxoBiopharmaceutical company Targacept, Inc. (Nasdaq:TRGT) announced this morning it made a drug development deal potentially worth more than $1.5 billion with GlaxoSmithKline Plc (NYSE:GSK). Targacept will host a conference call to discuss its latest deal today at 10 a.m. ET. Shares of Targacept jumped 32.11%, or $2.89, to $11.89 in pre-market trading.
Russell 2000 left behind
The Russell 2000 fell and the Dow gained ever so slightly after news the U.S. Federal Reserve remains focused on inflation. The Russell 2000 lost 2.13 points, or 0.25%, to finish at 833.18. The Dow Jones Industrial Average added 0.57 points, or 0.00%, to 13,424.96.
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The most significant risk facing the U.S. economy is that inflation will not moderate, Federal Reserve Bank of Cleveland Sandra Pianalto said this morning. She added that keeping inflation in check remains the Fed’s top priority.
Adolor tanks on negative trial results of bowel disorder drug
Adolor Corp. (Nasdaq: ADLR) reported late Monday disappointing clinical trial results of Entereg, its experimental treatment for the management of postoperative ileus – a bowel disorder commonly experienced by patients after surgery.
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