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FDA Skeptical of Amgen Drug Ahead of Panel
THOUSAND OAKS, Calif. (TheStreet) --
Amgen's effort to expand the use of new drug Xgeva to prevent or delay the spread of prostate cancer to the bones of patients is being met with skepticism by U.S. regulators who question whether such a claim has merit since the drug doesn't help patients live longer and may cause more side effects.
The U.S. Food and Drug Administration released its critique of Xgeva ahead of an advisory panel scheduled for Wednesday. Amgen already markets Xgeva for the treatment of bone-related side effects in patients being treated for cancer. The biotech firm wants FDA permission to expand Xgeva's label to allow the drug to be used to prevent or delay bone metastases in advanced prostate cancer patients.
Amgen shares were down 1% to $68.50 in early Monday trading. Investors have generally not expected Amgen to come out a winner at Wednesday's advisory panel and sales forecasts for Xgeva in this expanded indication are modest if they're modeled at all.
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How Your Credit Card Can Make Valentine's Day Cheaper
NEW YORK (MainStreet) -- You already know you can use your credit card to buy your Valentine a heartfelt gift, but you might not realize it can also help you save a few dollars on the holiday in the long run.
Issuers are known to offer deep discounts and additional cash-back bonuses on popular Valentine's Day items in their bonus point malls as Feb. 14 approaches. Here are a few of the better ones to consider.
There can deep credit discounts and additional cash-back bonuses on Valentine's Day items as Feb. 14 nears.
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Market Takes Heart; Bear Call Spread on FCX
The following commentary comes from an independent investor or market observer as part of TheStreet's guest contributor program, which is separate from the company's news coverage.
NEW YORK (Top Gun Options) -- The Bulls continue to rampage through the new calendar year, with 2012 so far providing Wall Street with one of its fastest starts since 1987. Still, the Top Gun Options trading team sees a number of obstacles remaining directly in the path of the upward trend.
The European Union sovereign debt crisis remains on the radar of Wall Street in a big way, though investors seem eager to focus on the improving metrics provided lately by both U.S. government reports and slightly better than expected fourth-quarter earnings reports. The Friday morning report released by the U.S. Department of Labor, indicating a drop in the unemployment rate to 8.3%, sent the market into a solid surge, where it remained for the most part throughout the day.
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They Just Don't Get Micron Technology!
Marek Fuchs, senior contributing analyst at TheStreet, examines Micron death coverage.
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Stock Futures Fall on Greece Default Fears
NEW YORK (TheStreet) -- U.S. stock futures were pointing to a lower open Monday as European debt default fears once again took center stage.
Futures for the Dow Jones Industrial Average were falling 36 points, or 54.2 points below fair value, at 12,757. Futures for the S&P 500 were falling 4.7 points, or 7 points below fair value, at 1334, and futures for the Nasdaq sliding 8 points, or 11.4 points below fair value, at 2515.
On Friday, the major U.S. stock finished their second best day of trading this year after investors celebrated an unexpected drop in the unemployment rate to its lowest level in almost three years.
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Insiders Trading WEN, UA, LULU, RDEA
By Jonathan Moreland, founder of Insider Insights and author of Profit From Legal Insider Trading.
NEW YORK (TheStreet) -- Which insiders are selling and buying chunks of stocks?
Below are lists of the top 10 mainly open-market insider purchases and sales filed at the Securities and Exchange Commission Friday, Feb. 3, 2012 as ranked by dollar value. Company executives and directors are in the best position to assess the attractiveness of their firms' shares, and here is how many of them are voting their wallets! Please note, however, that these are factual lists, not buy and sell recommendations. Dollar value is only one metric to assess the importance of an insider transaction....
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Stocks to Watch: Boeing, Micron (Update 1)
NEW YORK (TheStreet) -- Boeing has ordered inspections of all 787 Dreamliners already built after discovering a manufacturing error causing delamination on the fuselage.
"There is no short-term safety concern," company spokesman Scott Lefeber said in a statement Sunday, but "we have the issue well defined and are making progress on the repair plan."
The new flaw will further delay delivery of Boeing's first passenger jet built mainly of carbon-fiber composites. The new jetliner has already faced more than three years of delays.
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The Curse of Amylin's Diabetes Drug Approval
SAN DIEGO (TheStreet) -- Last week, after more than two and a half years, two FDA rejection letters, and at least a dozen amendments to the application, Amylin Pharmaceuticals received FDA approval for Bydureon, a once-weekly formulation of its existing diabetes drug Byetta.
Bydureon's approval reminds me of a favorite healthcare aphorism: "The worst thing a company can do is bring a drug to market." Commercialization means hope must yield to reality. For Amylin and Bydureon, reality isn't pretty.
Investors can be forgiven for only dimly remembering the rapturous excitement over Bydureon's initial phase II data, announced in August 2005, which implied the drug might be vastly more effective than Byetta with fewer side effects. Unfortunately, subsequent pivotal studies failed to replicate these early results. One of Amylin's Phase III studies even showed Bydureon to be less effective than Novo Nordisk's Victoza, a key competitor. Oops.
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Super Bowl XLVI, Citigroup: Hot Trends
NEW YORK (TheStreet) -- Popular searches on the Internet include Super Bowlafter the New York Giants' win over the New England Patriots in Super Bowl XLVI Sunday night, 21-17. The Giants became the first team to go 9-7 in the regular season and then go on to win the Super Bowl.
Giants quarterback Eli Manning was named the game's Most Valuable Player.
Super Bowl performers are also trending. Madonna, who headlined the halftime show, was joined by a a slew of other stars, including LMFAO, Nicki Minaj, M.I.A. and Cee Lo Green. Madonna escaped any controversy herself, as promised prior to her performance, but in a brief instant, M.I.A. showed her middle finger to the camera while delivering a line that had been censored. NBC apologized afterwards for the gesture, saying it was a spontaneous move that the delay system caught late.
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Euro Dragged Lower on Greece Uncertainty
NEW YORK (BBH FX Strategy) -- The dollar looks set to begin the week higher as the momentum from Friday's jobs report fades and the market refocuses its attention on Greek.
In particular, the dollar moved higher in Asia and into the European session prompted by the failure of Greek political leaders to reach an agreement on European Union/International Monetary Fund demands for further austerity. While an agreement was struck in principle, the devil, as is often the case, is in the details. The key sticking point in Greece and between it and the EU/IMF is wage cuts -- EU/IMF demanding 25% cut in wages and an end to the 13-to-14 month bonus payments.
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