La Jolla Shares Surge on Riquest Data

La Jolla Pharmaceutical Shares Surge on Presentation of Riquent Data

Shares of La Jolla Pharmaceutical Co. surged as the company highlighted positive data from several prior studies of its lupus drug candidate Riquent.

The stock surged $1.02, or 18.7 percent, to $6.49 in midday trading on more than 5 times average daily volume. Shares have traded between $2.77 and $8.68 over the last 52 weeks.
900-milligram doses were increasingly effective in reducing antibodies. The goal of the Phase III clinical study, results of which were first reported in March, was to prevent or delay renal flare in lupus patients with a history of the condition and antibodies to the disease. It involved 101 patients.

Renal (kidney) problems are very common in patients with lupus. Remember that lupus erythematosus is a disease caused by immune complexes. What this means is that the body produces immune complexes whenever there is an antibody response to a soluble antigen (infection that elicits and immune response). Lupus is a immune complex disease that is characterized by the formation of antibodies to DNA. As a normal process of cell turnover, nuclei [DNA] is exposed as newly made cells leave the bone marrow and mature into red blood cells.

These immune complexes are small and tend to be trapped/formed inside tissues and, primarily in the kidney. Renal disease is therefore the most frequently encountered symptom of LE.

Riquent's mechanism of action is to inhibit the production of autoantibodies from immune cells [B plasma cells]. Riquent is an immunomodulating agent that induces tolerance in B cells directed against double-stranded DNA. It does this by cross-linking surface antibodies. Tolerance basically is the cells not reacting to an antigen any further and sometimes the cells actually die. The fewer positive cells that produce autoantibodies then helps slow the progression of the disease.

DUSA Revisited: Shares Jump today:

A Continuation from post 4/29/07: Today;

DUSA Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for Levulan® (aminolevulinic acid HCl) Photodynamic Therapy (PDT) for the treatment of esophageal dysplasia. This disease occurs in some patients with Barrett's esophagus, a leading cause of esophageal cancer. The incidence of esophageal cancer is one of the most rapidly growing in the U.S., with more than 11,000 new diagnoses each year. Patients diagnosed with high grade dysplasia are at high risk for developing esophageal cancer and currently have limited treatment options.

Note that this is not a current indication from the FDA warning letter described on 29 April. Not even a skin lesion. Barrett's is a direct link to smoking, so this is big time news. More on how the mechanism of photoactivity treatment of dysplasia soon.

The Roller Coaster Ride Continues: DNDN

DNDN is up today (or this hour) ~40 cents a share in early afternoon trading. What's driving the volatility?
They are still trying to figure out exactly what the FDA really wants. More basic data is one thing, but additional clinical trial data and larger cohorts of patients is another.

One also has to realize that the patients in those clinical trials are at the last stages of the disease and are looking for something experimental to prolong life if not for a few days, or weeks.
The real benefit of the drug, in my opinion, would be to determine if the therapy is efficacious in newly diagnosed patients or people that have yet to present the later stages of disease. Using the treatments in combination with standard therapies is also being addressed.

DNDN is trading at $6.06 a share (up 6.5%) with roughly average volume.

DOW in uncharted waters today:

The Dow Jones industrial average rose 53.80, or 0.40 percent, to 13,362.87, after reaching a new trading high of 13,369.29. It was the blue chip index's 21st record close since the beginning of the year.

The Standard & Poor's 500 index advanced 4.86, or 0.32 percent, to 1,512.58 -- a new six-and-a-half-year high. The index is near its closing record of 1,527.46, reached March 24, 2000.

The Nasdaq composite index rose 4.59, or 0.18 percent, to 2,576.34.

The stock market has reacted well to the Fed's rate stance; the Dow has hit 43 record closes since the start of October, soon after the Fed stopped raising rates.


I believe that the most significant number here is the S & P being up, which is a more balanced index and IMO a better judge of overall economic strength. Let's ride the bull!!!

(Except DNDN--I will elaborate more on that disaster later....)

Stocks await Fed's move:

Wall street is anxious about todays Federal Reserve potential action that will outline it's decision on interest rates.

As soon as the news is out, it will be here.

In other biotech news, DNDN fell like a stone in today's trading, down 61% after the FDA requested additional data. I will update that news as well after market close.

Nasdaq is currently down 4.5 while the DOW is up 19.75.
The biotechnology index is down 0.5%.



UPDATE 11:30am PST---The Federal Reserve decided not to raise a key interest rate today. The funds rate will remain unchanged (the rate which banks charge each other) at 5.25%. Stocks intially retreated after the news, but have rallieda bit in afternoon trading.

Sunday Summary: What will the Fed do on Monday?

biotech follows the big boys:

After another record-setting week on Wall Street, investors are wondering whether stocks are due for a fall or are headed even higher. This week's words from the Federal Reserve and retail sales could provide some clues.

Recently, it has seemed as if nothing can derail the stock market's climb. Economic reports last week were mixed, but institutional investors remained enthusiastic thanks to soaring takeover activity. News Corp.'s bid for Dow Jones & Co. reinvigorated the stock market Tuesday after a morning of mixed economic news, and on Friday, reports that Microsoft Corp. might be mulling a buy of Yahoo Inc. nudged stocks higher despite lackluster jobs data.

Overall, economic data has shown slow and steady growth, alleviating investors' fears about recession. Still, worries linger about stagflation -- slowing growth amid soaring prices -- and what the Federal Reserve would do about it.

ApotheCure pulls injectable colchicine drug:

ApothéCure and FDA notified all healthcare professionals of recent deaths associated with the use of compounded injectable Colchicine 0.5mg/ml, 4ml vials, lot number 20070122@26. The company issued an immediate drug recall for all strengths, sizes and lots of compounded Injectable Colchicine sold within the last year. Customers are asked to examine their stock for ApothéCure compounded Colchicine on hand and to discontinue use immediately and prepare the product for return to the company.

I will elaborate on this later today. Briefly, colchicine is a anti cancer drug that stabilizes microtubules to keep cells from dividing.