Shares of biotech�Dynavax Technologies� (NASDAQ: DVAX ) �plunged 30% this morning after the company provided an update on its experimental hepatitis B vaccine Heplisav. According to its press release, the company met with the Food & Drug Administration, and the regulatory agency has stated that Dynavax simply doesn't have enough data to confirm the safety of the vaccine.
This can't come as a total surprise to investors who have been tracking Dynavax over the last few months. Back in November, the FDA's advisory committee overwhelmingly voted in favor of the vaccine's efficacy. The major problem, however, was the lack of data to support the drug's safety in the broad age range that the company was seeking approval for (ages 18-70). The committee voted 8-5, with one member abstaining, that the company needed more safety data. A Complete Response Letter from the FDA quickly followed in February, and a lack of safety data was again cited as the main reason for the rejection.
Hot Safest Stocks For 2014: St. Jude Medical Inc.(STJ)
St. Jude Medical, Inc. develops, manufactures, and distributes cardiovascular and implantable neurostimulation medical devices worldwide. It operates in four segments: Cardiac Rhythm Management, Cardiovascular, Atrial Fibrillation, and Neuromodulation. The Cardiac Rhythm Management segment offers products for cardiac arrhythmias, or irregular heart beats. Its products include tachycardia implantable cardioverter defibrillator systems to provide therapy to patients suffering from lethal heart conditions, such as sudden cardiac arrest; cardiac resynchronization therapy devices to treat heart failure patients; pacemakers to help people whose hearts beat too slowly or who suffer from other cardiac arrhythmias; and leads, which connect devices to the heart and carry the electrical impulses to the heart and information from the heart to the device. The Cardiovascular segment offers mechanical and tissue replacement heart valves, as well as heart valve repair products. It also pr ovides disposable interventional devices, including vascular closure devices, compression assist devices, percutaneous catheter introducers, diagnostic guidewires, and temporary bipolar pacing catheters, as well as diagnostic coronary imaging technology. The Atrial Fibrillation segment offers a system of products for access, diagnosis, visualization, and ablation that assist physicians in diagnosing and treating various irregular heart rhythms used in the electrophysiology lab and cardiac surgery. It provides electrophysiology introducers and catheters, cardiac mapping, navigation and recording systems, and ablation systems. The Neuromodulation segment offers a range of neurostimulation systems, such as rechargeable implantable pulse generators, primary cell implantable pulse generators, and radio frequency powered systems. St. Jude Medical markets its products through a direct sales force and independent distributors. The company was founded in 1976 and is headquartered in St. Paul, Minnesota.
Advisors' Opinion:- [By Rahemtulla]
St. Jude Medical(STJ) makes devices for cardiac rhythm management and cardiac surgery.
It reported fourth-quarter results last week. St. Jude's adjusted earnings of 75 cents, representing 17% year-over-year growth, exceeded analysts' consensus target by 1.8% and its nearly $1.4 billion of sales beat the consensus by 2.5%, but the stock dropped 1% upon announcement. The operating profit margin dropped from 29% to 25%. Still, return on equity, a key measure of efficiency for stock holders, at 21%, beat the peer group and S&P 500 averages.
Jefferies had a positive reaction to the report, noting that St. Jude is poised to gain market share in 2011 on new products. St. Jude has attractive growth rates, having boosted sales and net income 11% and 18% annually, on average, over a three-year span. It is investing heavily in research and development to maintain its above-peer growth. Jefferies forecasts research spending rising from 12% of sales to nearly 13% in 2011. Although this investment spending will hinder margins in the near-term, it will also ensure continuation of St. Jude's robust product pipeline.
Bullish Scenario: JPMorgan expects St. Jude to gain 27% to $52.
Bearish Scenario: Citigroup predicts a drop of more than 7% to $38.
Hot Safest Stocks For 2014: Hot Topic Inc.(HOTT)
Hot Topic, Inc., together with its subsidiaries, operates as a mall- and Web-based specialty retailer in the United States. The company operates Hot Topic and Torrid store concepts, as well as an e-space music discovery concept, ShockHound. Its Hot Topic stores sell music/pop culture-licensed merchandise, including tee shirts, hats, posters, stickers, patches, postcards, books, novelty accessories, CDs, and DVDs; and music/pop culture-influenced merchandise comprising women?s and men?s apparel and accessories, such as woven and knit tops, skirts, pants, shorts, jackets, shoes, costume jewelry, body jewelry, sunglasses, cosmetics, leather accessories, and gift items for young men and women primarily between the ages of 12 and 22. The company?s Torrid stores sells casual and dressy jeans and pants, fashion and novelty tops, sweaters, skirts, jackets, dresses, hosiery, shoes, intimate apparel, and fashion accessories for various lifestyles for plus-size females primarily betw een the ages of 15 and 29. As of July 30, 2011, it operated 636 Hot Topic stores in 50 states, Puerto Rico, and Canada; 145 Torrid stores; and Internet stores, hottopic.com and torrid.com. The company was founded in 1988 and is headquartered in City of Industry, California.
Advisors' Opinion:- [By Wyatt Research]
The teen retailer reported its same-store sales rose 0.4 percent, with same-store sales at its Torrid chain for overweight teens rising 7 percent. Analysts were expecting a decline.
Top 10 Dividend Stocks To Watch For 2014: Fairfax Financial Holdings Ltd (FRFHF.PK)
Fairfax Financial Holdings Limited (Fairfax) is a financial services holding company. The Company, through its subsidiaries, is principally engaged in property and casualty insurance and reinsurance and the associated investment management. The Company�� segments consist of Insurance, Reinsurance, Insurance and Reinsurance Other, Runoff, and Corporate and Other. On December 22, 2011, the Company completed the acquisition of 75% interests in Sporting Life Inc. On August 16, 2011, the Company acquired William Ashley China Corporation. On March 24, 2011, an indirect wholly owned subsidiary of Fairfax completed the acquisition of The Pacific Insurance Berhad. On February 9, 2011, an indirect wholly owned subsidiary of Fairfax completed the acquisition of First Mercury Financial Corporation. In October 2012, its RiverStone runoff subsidiary acquired all the outstanding shares of Brit Insurance Limited.
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