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Closing Bell: An almost disappointment, sort of... (DNDN, AAPL, GE, C, AMR)

The recession is over according to Ben Bernanke. Inflation is staying tame. And the Fed just said we all saw our wealth grow in Q2. Yet today the markets gave back. Based upon many key tech shares hitting 52-week highs and then selling off, this was just a day of traders finally locking in some handy trading profits. The DJIA stayed up for much of the day, but the rest of the key indexes came well off of highs and many went negative. This call for DJIA 10,000 still seems much more likely even if the market showed that not every index has to rise every day.

Here are today's unofficial closing bell levels:

Dow 9,784.22 -7.49 (-0.08%)
S&P 500 1,065.49 -3.27 (-0.31%)
Nasdaq 2,126.75 -6.40 (-0.30%)

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Continue reading Closing Bell: An almost disappointment, sort of... (DNDN, AAPL, GE, C, AMR)

Despite earlier skepticism Dendreon (DNDN) proves itself -- shares soar

Dendreon Corp. (NASDAQ: DNDN) shares more than tripled today soaring from a previous close of $7.30 to $22.10. By noon DNDN traded up over 130% to around $17 a share. The company reported this morning that its experimental prostate cancer treatment, Provenge, was significantly successful in prolonging patient survival. This may clear the way for the long-awaited regulatory approval for the drug.

Dendreon plans to submit additional information to the FDA in the fourth quarter as part of its new drug application, meaning approval could come with six months, by mid- 2010.

Continue reading Despite earlier skepticism Dendreon (DNDN) proves itself -- shares soar

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

Peregrine Pharmaceuticals (PPHM) may be delisted; clinical trials at risk

Peregrine Pharmaceuticals Incorporated (NASDAQ: PPHM) is in such poor financial shape that it has been delisted has received a notice of its failure to meet continuing NASDAQ Capital Market requirements and may soon be delisted. The stock is currently priced at $0.70 and does not publicly trade.

Why should investors care whether a small biopharmaceutical company implodes like so many long-ago dot coms? Because Peregrine is running several important clinical trials testing whether its product, bavituximab, might be another weapon in the fight against prostate and breast cancers, diseases which kill tens of thousands of Americans every year. In the fight against cancer, every likely beneficial treatment scenario needs to be pursued aggressively.

Peregrine recently raised $21 million from institutional investors in order to fund the continued collection of data in its clinical trials. This is good news, except that the clinical trials are being run not in the US, but in India where there are fewer patient protection policies and data collection and analysis is much cheaper to produce. Presumably, credible evidence from the India clinical trials will convince the FDA to allow clinical trials using bavituximab in the US.

A recent piece of good news for Peregrine is that the Department of Defense is investigating whether bavituximab may be effective in treating hemorrhagic fever. It is possible that Peregrine will be awarded a five-year contract worth almost $45 million to develop treatment protocols and run clinical trials investigating this use of its product. Such a contract would help Peregrine immensely. In its most recent quarterly report, Peregrine recorded a net loss of $4.65 million, less than last year's $5.45 million loss, but hardly good news. Peregrine did post $1.6 million in earnings from its wholly owned contract drug manufacturing subsidiary Avid Biosciences. If bavituximab does prove effective in the fight against some types of cancer, and if the drug does win FDA approval for use in the U.S., then Peregrine will have in-house manufacturing facilities. The need for such expertise currently seems a long ways away for Peregrine, which may be an attractive buy-out candidate by a much larger pharmaceutical company.

Symbol Lookup
IndexesChangePrice
DJIA+30.6910,464.40
NASDAQ+6.872,176.05
S&P 500+4.981,110.63

Last updated: November 27, 2009: 08:40 AM

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