Continue reading Dendreon Fluctuates on FDA Rumors

Dendreon Fluctuates on FDA Rumors originally appeared on BloggingStocks on Tue, 02 Mar 2010 13:40:00 EST. Please see our terms for use of feeds.

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

Closing Bell: An almost disappointment, sort of... (DNDN, AAPL, GE, C, AMR) originally appeared on BloggingStocks on Thu, 17 Sep 2009 16:00:00 EST. Please see our terms for use of feeds.

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

Despite earlier skepticism Dendreon (DNDN) proves itself -- shares soar originally appeared on BloggingStocks on Tue, 14 Apr 2009 14:30:00 EST. Please see our terms for use of feeds.

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

Dendreon delays request for FDA approval of prostate cancer drug originally appeared on BloggingStocks on Fri, 16 Jan 2009 15:15:00 EST. Please see our terms for use of feeds.

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.

Peregrine Pharmaceuticals (PPHM) may be delisted; clinical trials at risk originally appeared on BloggingStocks on Fri, 14 Sep 2007 08:29:00 EST. Please see our terms for use of feeds.