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Smart Choices halts its labeling program

A very interesting piece of news passed the wire late Friday, October 23. Smart Choices, which is a million-dollar food labeling program, was voluntarily halted on Friday thanks to a bit of mislabeling.

Earlier in the week, the Food and Drug Administration (FDA) announced that it was looking into Smart Choices' labeling practices. The FDA feels that Smart Choices (although the company wasn't named as a specific target by the government) may use misleading labels on some of the products it has deemed nutritionally sound.

Continue reading Smart Choices halts its labeling program

Closing Bell: The dollar-stock relation cuts both ways (AMZN, BCRX, XOM, FNM, FITB, GLD)

Today started out higher for stocks, but then the US Peso came into play. Shares have been the beneficiary of a weakening dollar, but then the currency bears started to cover the position. There is talk that some foreign central banks intervened to halt the rise of their own currencies, although whether or not that was the case may not be known.

Here were today's unofficial closing bell levels:

Dow 9,867.81 -104.37 (-1.05%)
S&P 500 1,066.98 -12.62 (-1.17%)
Nasdaq 2,141.85 -12.62 (-0.59%)

Top Analyst Calls
Top Stock/Market Rumors
Top Day Trader Alerts

Continue reading Closing Bell: The dollar-stock relation cuts both ways (AMZN, BCRX, XOM, FNM, FITB, GLD)

Closing Bell: Deals drive home (AMGN, S, IPCS, CIT, FNM, FRE)

Despite a cautious report from home builders and despite a low volume day, today marked a clear win for the S&P 5000 and for the DJIA. The S&P broke through 1,100 and the DJIA broke through 11,000. We also had two mergers this morning, and while small they are signs that companies are willing to merge once more.

Here were today's closing bell levels:

Dow 10,090.76 +94.85 (0.95%)
S&P 500 1,097.52 +9.84 (0.90%)
Nasdaq 2,175.83 +19.03 (0.88%)

Top 10 Analyst Calls
Top Day Trader Alerts
Top Stock Rumors

Continue reading Closing Bell: Deals drive home (AMGN, S, IPCS, CIT, FNM, FRE)

Depomed sinks on dismal drug news

Depomed Inc. (NASDAQ: DEPO) opened Monday on a loss of nearly 50%, as traders panned the company's clinical trial results for Serada. The drug, which is intended to treat hot flashes related to menopause, met only one one of four co-primary goals in late-stage trials after 12 weeks.

Depomed was hoping to prove that Serada could help patients achieve a "statistically significant reduction in the frequency and severity of menopausal hot flashes." However, the company confessed that the placebo effect was unexpectedly high in clinical studies.

Continue reading Depomed sinks on dismal drug news

Spectrum Pharma (SPPI) drops on cancer drug setback

SPPI logoSpectrum Pharmaceutical (NASDAQ: SPPI - option chain) stock is trading lower today after the company received a Complete Response letter from the FDA regarding FUSILEV, its treatment for advanced metastatic colorectal cancer. The FDA said the company did not demonstrate that FUSILEV is non-inferior to leucovorin in its supplemental New Drug Application. If you think this stock won't be rising too far in the coming months, then it could be a good time to look at a bearish hedged play on SPPI.

This morning, SPPI opened at $4.98. So far today the stock has hit a high of $5.44 and a low of $4.82. As of 12:00, SPPI is trading at $5.12, down $1.09 (-17.6%). The chart for SPPI looks neutral.

Continue reading Spectrum Pharma (SPPI) drops on cancer drug setback

MannKind (MNKD) drops 25%+ on FDA delay

MNKD logoMannKind (NYSE: MNKD - option chain) stock is trading lower today after the company said it will be unable to strike a partnership deal for its inhaled insulin product, Afresa, by the end of the year. The delay is due to a lag in obtaining FDA approval for Afresa, which may not come until January 2010. If you think this stock won't be rising too far in the coming months, then it could be a good time to look at a bearish hedged play on MNKD.

This morning, MNKD opened at $8.03. So far today the stock has hit a high of $8.03 and a low of $6.52. As of 12:55, MNKD is trading at $6.77, down $2.44 (-26.5%). The chart for MNKD looks bullish.

Continue reading MannKind (MNKD) drops 25%+ on FDA delay

Purdue Pharma fights OxyContin abuse

OxyContinWhen Purdue Pharma introduced its pain killer OxyContin to the market back in 1997 the drug was hailed as a savior for seriously ill patients. Unfortunately, what makes the drug so effective also makes it highly addictive, and easily abused. Purdue Pharma has taken steps recently to help prevent abuse, and today the FDA announced that the changes do offer some "limited" advantages over the original pill.

The drug is definitely effective when used properly by severely ill patients dealing with intense pain. It was designed to give patients a steady does of the pain killer over a 12-hour period.

Continue reading Purdue Pharma fights OxyContin abuse

FDA raises issues with Genzyme's leukemia drug study

The U.S. Food and Drug Administration (FDA) has some questions for Genzyme Corp. (NASDAQ: GENZ) regarding trial data for its leukemia drug, Clolar. Because Genzyme didn't follow the FDA's recommendations in conducting its main study of Clolar, the regulatory agency is reluctant to make a decision on the basis of the trial results.

In 2007, FDA staff advised Genzyme to conduct a randomized study in which participants receiving Clolar would be compared against a set of patients not receiving the drug. However, the drug company's primary tests did not include a control group; instead, the treatment was tested only on elderly patients with acute myeloid leukemia (AML).

Continue reading FDA raises issues with Genzyme's leukemia drug study

Cell Therapeutics spikes on FDA approval

Cell Therapeutics Inc. (NASDAQ: CTIC) caught a boost this morning after the U.S. Food & Drug Administration (FDA) accepted its new drug application for pixantrone, an experimental drug for the treatment of relapsed, aggressive non-Hodgkin's lymphoma. The FDA's action date for review of pixantrone will be set by Sept. 4.

CTIC surged more than 6% out of the gate this morning, tagging a session high of $1.80, but the low-priced shares have since whittled their gains. The equity, which has rallied 1,107.1% year-to-date, is currently trading sideways between support at its 10-week moving average and resistance near the $2 level.

Continue reading Cell Therapeutics spikes on FDA approval

Cash-strapped Repros Therapeutics warns of potential bankruptcy

Repros Therapeutics (NASDAQ: RPRX) easily takes the prize for most dismal earnings report of the day. Not only did the drug firm report a wider-than-forecast second-quarter loss, it also warned that bankruptcy is a real possibility unless the company can secure significant additional capital.

Specifically, Repros confessed to a second-quarter net loss of $8.9 million, or 59 cents per share, compared to Wall Street's consensus estimate for a loss of 46 cents per share. The company chalked up its poor results to a 16% annualized increase in clinical development activities for Proellex -- which has been placed on clinical hold by the FDA -- as well as a 60% year-over-year jump in general and administration expenses.

Continue reading Cash-strapped Repros Therapeutics warns of potential bankruptcy

Matrixx Initiatives plummets to 11-year low on SEC inquiry

Matrixx Initiatives (NASDAQ: MTXX), maker of the allegedly scent-stealing Zicam nasal swabs, tumbled to a new annual low this morning on news that the Securities and Exchange Commission (SEC) is launching an informal inquiry. The SEC is requesting documents and other information regarding the warning letter issued to Matrixx by the U.S. Food and Drug Administration.

Last week, the FDA told consumers to stop using certain nasally administered Zicam products after the agency received more than 130 complaints from users who lost their sense of smell. Matrixx has defended its homeopathic, over-the-counter offerings, calling the safety concerns "erroneous," but the firm settled hundreds of lawsuits in 2006 with consumers making the same allegations.

Continue reading Matrixx Initiatives plummets to 11-year low on SEC inquiry

United Therapeutics (UTHR) hit by drug delay

UTHR logoUnited Therapeutics (NASDAQ: UTHR - option chain) stock is falling today after the company announced it expects a probable delay in receiving FDA approval for Tyvaso, its inhaled drug to treat pulmonary hypertension. If you think this stock won't be rising too far in the coming months, then it could be a good time to look at a bearish hedged play on UTHR.

This morning, UTHR opened at $59.90. So far today the stock has hit a low of $59.35 and a high of $62.34. As of 11:40, UTHR is trading at $61.08, down $5.20 (-7.9%). The chart for UTHR looks bearish.

Continue reading United Therapeutics (UTHR) hit by drug delay

Geron CEO: Stock 'would have tripled' in normal market conditions

The shares of Geron Corporation (NASDAQ: GERN) rocketed sharply higher on Jan. 23, when the Food and Drug Administration (FDA) granted approval for the world's first clinical trial of human stem cells. Now, GERN has collected an impressive year-to-date gain of 57.8%. However, CEO Thomas Okarma isn't feeling too complacent with his stock's respectable rally. He told Reuters Tuesday, "If this were a normal macro environment, our stock would have tripled with this kind of advance."

No doubt, the FDA's timing could have been better, since Okarma says more money is needed for academic stem cell research -- and demands on federal funding have rarely been greater. "There's no question that there are a lot of big fish in the Washington frying pan these days," commented the CEO. He's calling for the establishment of a presidential commission on stem cell policy to keep the industry on Washington's radar.

Continue reading Geron CEO: Stock 'would have tripled' in normal market conditions

Geron (GERN) rockets 50% on trial's FDA clearance

GERN logoGeron (NASDAQ: GERN - option chain) shares have shot more than 50% higher today after the FDA granted the company clearance to begin trials of a human embryonic stem cell-based therapy for people with spinal chord injuries. This monumental step officially is in no part President Obama's doing, but he has made his stance clear on the use of stem cells, and included a line in his inauguration speech that mentioned that "We will restore science to its rightful place, and wield technology's wonders to raise health care's quality and lower its cost." If you think that the stock won't fall by too much in the coming months, then now could be a good time to look at a bullish hedged trade on GERN.

GERN opened this morning at $6.48. So far today the stock has hit a low of $6.19 and a high of $8.38. As of 12:20, GERN is trading at $7.93, up $2.72 (52.2%). The chart for GERN looks bullish.

For a bullish hedged play on this stock, I would consider a March bull-put credit spread below the $5 range. A bull-put credit spread is an options position that combines the purchase and sale of put options to hedge risk in case the stock doesn't do what you think but still leverage nice returns. For this particular trade, we will make an 11.1% return in just two months as long as GERN is above $5 at March expiration. Geron would have to fall by more than 43% before we would start to lose money. Learn more about this type of trade here.

Brent Archer is an options analyst and writer at Investors Observer.

DISCLOSURE: Mr. Archer owns and/or controls diversified portfolios of long and short stock and option positions that may include holdings in companies he writes about. At publication time, Brent neither owns nor controls positions in GERN. He does own STEM
.

Dendreon delays request for FDA approval of prostate cancer drug

Dendreon (NASDAQ: DNDN) is a classic example of how a company fares as they struggle through the arcane and sometimes bewildering process of gaining FDA approval of a new treatment protocol.

A little more than a year and a half ago, the Seattle-based company was anxiously awaiting FDA approval of its new drug treatment protocol for prostate cancer.

The company's new drug, Provenge, had completed a trial that found that the treatment extended the lives of men suffering from prostate cancer an average of 4.5 months over those who did not receive the treatment. The company felt it had adequately demonstrated the efficacy of the treatment and deserved FDA approval.

In an unexpected but somewhat typical move, the FDA chose not to approve the drug for distribution at that time. It opted to delay approval until completion of another study under way with 500 subjects. This came in spite of a finding by an FDA panel that the drug was "safe and substantially effective."

Continue reading Dendreon delays request for FDA approval of prostate cancer drug

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Symbol Lookup
IndexesChangePrice
DJIA+132.7910,450.95
NASDAQ+29.972,176.01
S&P 500+14.861,106.24

Last updated: November 24, 2009: 08:27 AM

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