Genentech shares have nose-dived 16% over the last 6 months--from $89.05 on January 19 to $74.78 on June 7--due, at least in part, to a dearth of positive, stock-moving news. But that decline could now give stock-pickers just the right opportunity to buy.
Proving that point Jennifer Chao, an analyst at Deutsche Bank, says Genentech (nyse: DNA - news - people ) is a smart pickup because of a 52-week low in share price and a compelling valuation.
Also, Chao said there are new developments afoot that could act as catalysts for the stock. "The next 12 months represent major upside to fundamentals with multiple shots on goal," Chao wrote.
She wrote that her analysis shows positive results for the Phase III C-08 adjuvant colon cancer study, assigning a 60% positive outlook on first interim look in the second half of 2007, 75% on second interim look in the first-half of 2008, and 85% on third interim look in the second half of 2008.
A significant positive interim analysis in the second-half of 2007, Chao wrote, would translate into near immediate off-label usage and rapid penetration into adjuvant colon cancer with implications in other off-label indications. Regulatory filing would be anticipated in the first-half of 2008, with approval by late 2008 or early 2009.
Chao upgraded Genentech to "buy" from "hold." In Monday morning trading, shares of the company rose 1%, or 76 cents, to $77.73.
Source: Forbes online
Tuesday, June 12, 2007
Thursday, May 24, 2007
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.
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.
Thursday, May 17, 2007
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.
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.
Wednesday, May 16, 2007
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.
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.
Wednesday, May 09, 2007
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....)
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.
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, May 06, 2007
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.
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.
I will elaborate on this later today. Briefly, colchicine is a anti cancer drug that stabilizes microtubules to keep cells from dividing.
Sunday, April 29, 2007
DUSA Pharmaceuticals Receives FDA Warning letter
DUSA received a warning letter from the FDA concerning NDA #20-965 (Levulan Kerastick---aminolevulinic acid HCl ) topical solution.
It reads as follows:
"The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed an advertisement (MKT-1330 Rev C) for Levulan
Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% (Levulan Kerastick) submitted by
DUSA Pharmaceuticals, Inc. (DUSA) under cover of Form FDA 2253. The advertisement is false or misleading because it presents efficacy claims for Levulan Kerastick, but omits and minimizes the risks associated with the use of the drug, broadens the indication, and overstates the efficacy of the drug. Therefore, the advertisement misbrands Levulan Kerastick in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 352(n) and 321(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(5); (e)(6)(i). This advertisement raises significant public health and safety concerns because it suggests that Levulan Kerastick is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience."
Bascially they are saying the company is misrepresenting the product by making claims of treating keratoses without data to support these claims.
SO WHAT IS THIS Levulan Kerastick?
Levulan Kerastick is a topical treatment for actinic keratoses (AK). Actinic keratoses are a direct result of prolonged exposure to sunlight. It is a small crusty, scaly or crumbly bump or horn that arises on the skin surface. They most likely appear on the face, lips, ears, scalp, neck, backs of the hands and forearms, shoulders and back — the parts of the body most often exposed to sunshine. AK's are considered the earliest stage in the development of skin cancer and they have the ability to progress into malignant skin cancer (squamous cell carcinoma).
The mechanism of action of levulan is not completely known and what is know in complicated. In brief, the drug consists of aminolevulinic acid (ALA) which is involved in heme synthesis (circular molecular structures much like the heme group in hemoglobin that carries molecular oxygen in red blood cells). The aminolevulinic acid is activated by sunlight and another product the patient applies that centers a very specific wavelength of light onto the affected area. When activated by light, the ALA is converted to another compound which then releases molecular oxygen (free radicals) and hydroxide ions. These molecular entities act as cytotoxic agents to kill kertosis developing cells.
That's a very basic mechanism of action of how this drug works, and has very complicated chemistry involved that I'm not exactly clear on either. Hope this helps.
DUSA closed friday's trading up 23 cents per share at $3.43. Investors do not seem to be worried.
It reads as follows:
"The Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has reviewed an advertisement (MKT-1330 Rev C) for Levulan
Kerastick (aminolevulinic acid HCl) for Topical Solution, 20% (Levulan Kerastick) submitted by
DUSA Pharmaceuticals, Inc. (DUSA) under cover of Form FDA 2253. The advertisement is false or misleading because it presents efficacy claims for Levulan Kerastick, but omits and minimizes the risks associated with the use of the drug, broadens the indication, and overstates the efficacy of the drug. Therefore, the advertisement misbrands Levulan Kerastick in violation of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. §§ 352(n) and 321(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(5); (e)(6)(i). This advertisement raises significant public health and safety concerns because it suggests that Levulan Kerastick is safer and more effective than has been demonstrated by substantial evidence or substantial clinical experience."
Bascially they are saying the company is misrepresenting the product by making claims of treating keratoses without data to support these claims.
SO WHAT IS THIS Levulan Kerastick?
Levulan Kerastick is a topical treatment for actinic keratoses (AK). Actinic keratoses are a direct result of prolonged exposure to sunlight. It is a small crusty, scaly or crumbly bump or horn that arises on the skin surface. They most likely appear on the face, lips, ears, scalp, neck, backs of the hands and forearms, shoulders and back — the parts of the body most often exposed to sunshine. AK's are considered the earliest stage in the development of skin cancer and they have the ability to progress into malignant skin cancer (squamous cell carcinoma).
The mechanism of action of levulan is not completely known and what is know in complicated. In brief, the drug consists of aminolevulinic acid (ALA) which is involved in heme synthesis (circular molecular structures much like the heme group in hemoglobin that carries molecular oxygen in red blood cells). The aminolevulinic acid is activated by sunlight and another product the patient applies that centers a very specific wavelength of light onto the affected area. When activated by light, the ALA is converted to another compound which then releases molecular oxygen (free radicals) and hydroxide ions. These molecular entities act as cytotoxic agents to kill kertosis developing cells.
That's a very basic mechanism of action of how this drug works, and has very complicated chemistry involved that I'm not exactly clear on either. Hope this helps.
DUSA closed friday's trading up 23 cents per share at $3.43. Investors do not seem to be worried.
Thursday, April 26, 2007
Earnings update: 4-26-07
MMM up over 3 dollars per share (>4%) to $80.15.
BMY is down 60 cents a share to 29.11 as they are reporting lower 1Q profit as reflected by generic introduction of Plavix. BMY also lost patent protection of it's cholesterol drug Pravachol.
CYTK earnings due at 1:30pm Pacific. CYTK is trading down 5 cents/share in morning trading at $6.62.
IDIX earnings due at 1:30p pacific. Trading a bit down in light morning trading as investors await results.
MLNM is down 40 cents a share by narrowed 1Q losses, helped by higher sales of its cancer drug Velcade, royalties and a decrease in stock-based compensation expense. MLNM is trading at $11.55 a share at this hour.
BMY is down 60 cents a share to 29.11 as they are reporting lower 1Q profit as reflected by generic introduction of Plavix. BMY also lost patent protection of it's cholesterol drug Pravachol.
CYTK earnings due at 1:30pm Pacific. CYTK is trading down 5 cents/share in morning trading at $6.62.
IDIX earnings due at 1:30p pacific. Trading a bit down in light morning trading as investors await results.
MLNM is down 40 cents a share by narrowed 1Q losses, helped by higher sales of its cancer drug Velcade, royalties and a decrease in stock-based compensation expense. MLNM is trading at $11.55 a share at this hour.
Wednesday, April 25, 2007
Biotech Earnings Reports for Thursday, 4-26-07
Of the major pharmaceutical companies reporting tomorrow are:
3M (MMM)- time not specified. 3M has a hefty pipeline of drugs. Of note is the line of TLR agonists of their HCV and cancer interest. They are actively seeking a drug to complement imiquimod that treats HCV in addition to genital warts. MMM is expected to earn over 1 dollar per share.
Bristol-Myers Squibb (BMY) will announce earnings at an unspecified time. BMY has interests in cancer, ERBITUX and TAXOL. Viral products include Baraclude, which is a HBV drug. BMY is anticipating a 23 cent per share earning.
Cytokinetics (CYTK) will announce again at an unspecified time. CYTK is actively pursuing cardiovascular small molecule drugs. Cytokinetics is expected to report a net loss of40 cents per share.
Idenix Pharmaceuticals (IDIX) will announce a proposed loss of 30 cents per share. IDIX concentrates on viral diseases such as HCV, HBV and HIV. They have several drugs in phase IIb and II for treatment of HBV and HCV. IDIX is proposed to report a net 30 cent loss per share.
Millennium Pharmaceuticals (MLNM) will report no change before the market opens. MLNM has leukemia drugs in it's pipeline.
Will keep you posted on Friday's reports.
3M (MMM)- time not specified. 3M has a hefty pipeline of drugs. Of note is the line of TLR agonists of their HCV and cancer interest. They are actively seeking a drug to complement imiquimod that treats HCV in addition to genital warts. MMM is expected to earn over 1 dollar per share.
Bristol-Myers Squibb (BMY) will announce earnings at an unspecified time. BMY has interests in cancer, ERBITUX and TAXOL. Viral products include Baraclude, which is a HBV drug. BMY is anticipating a 23 cent per share earning.
Cytokinetics (CYTK) will announce again at an unspecified time. CYTK is actively pursuing cardiovascular small molecule drugs. Cytokinetics is expected to report a net loss of40 cents per share.
Idenix Pharmaceuticals (IDIX) will announce a proposed loss of 30 cents per share. IDIX concentrates on viral diseases such as HCV, HBV and HIV. They have several drugs in phase IIb and II for treatment of HBV and HCV. IDIX is proposed to report a net 30 cent loss per share.
Millennium Pharmaceuticals (MLNM) will report no change before the market opens. MLNM has leukemia drugs in it's pipeline.
Will keep you posted on Friday's reports.
Friday, April 20, 2007
AVNR--riding a wave of good fortune
Avanir is still riding gains made since wednesday's announcement of positive results of Zenvia in diabetic neuropathy.
Minutes before the market closes today AVNR is up 11.5%, (that's another 46 cents a share ) to $4.37.
This stock might hit 10 dollars before this is all over!
Minutes before the market closes today AVNR is up 11.5%, (that's another 46 cents a share ) to $4.37.
This stock might hit 10 dollars before this is all over!
Wednesday, April 18, 2007
AVANIR Pharmaceuticals Says Drug Shows Positive Results; Shares Soar
ALISO VIEJO, Calif.--(BUSINESS WIRE)--Avanir Pharmaceuticals today announced positive top-line results from the company's Phase III clinical trial evaluating the investigational drug Zenvia (dextromethorphan hydrobromide/quinidine sulfate ("DMQ")), an NMDA antagonist and sigma-1 agonist, in diabetic neuropathic pain.
HOW DOES ZENVIA WORK TO TREAT NEUROPATHIC PAIN? What is diabetic neuropathic pain?
Neuropathic pain is a condition basically defined by "as pain initiated or caused by a primary
lesion or dysfunction in the nervous system". That means researchers and doctors really don't know what actually causes neuropathy, but are working on how to treat the symptoms. The pain is described as shooting, electric or radiant. The pain was once described by elderly patients was that of their feet literally feeling like they were on fire and the patients had to be heavily sedated to combat it. I read somewhere in graduate school once that one person literally tried to cut their own foot off because of the pain.
So what about Zenvia? NMDA receptors are found in the brain (called glutamate receptors) that are mainly responsible for regulation of calcium flow in neurons. You may have heard of dextromethorphan as a cough suppressant. Inhibition of NMDA receptors stops calcium signaling, which is thought to alleviate pain.
Quinidine sulfate was originally used as a cardiac rhythmic drug. It's use in this case is stop the action of enzymes that degrade the dextromethorphan, thus raising it's therapeutic window.
Because of the encouraging data, AVNR ended today's trading up over 300% or $3.92 per share to close at $5.40 after hours.
HOW DOES ZENVIA WORK TO TREAT NEUROPATHIC PAIN? What is diabetic neuropathic pain?
Neuropathic pain is a condition basically defined by "as pain initiated or caused by a primary
lesion or dysfunction in the nervous system". That means researchers and doctors really don't know what actually causes neuropathy, but are working on how to treat the symptoms. The pain is described as shooting, electric or radiant. The pain was once described by elderly patients was that of their feet literally feeling like they were on fire and the patients had to be heavily sedated to combat it. I read somewhere in graduate school once that one person literally tried to cut their own foot off because of the pain.
So what about Zenvia? NMDA receptors are found in the brain (called glutamate receptors) that are mainly responsible for regulation of calcium flow in neurons. You may have heard of dextromethorphan as a cough suppressant. Inhibition of NMDA receptors stops calcium signaling, which is thought to alleviate pain.
Quinidine sulfate was originally used as a cardiac rhythmic drug. It's use in this case is stop the action of enzymes that degrade the dextromethorphan, thus raising it's therapeutic window.
Because of the encouraging data, AVNR ended today's trading up over 300% or $3.92 per share to close at $5.40 after hours.
Tuesday, April 10, 2007
Memory Pharmaceuticqls Continues Gains
Memory Pharma extended it's gains from Monday today on news that it's leading Alzheimer's drug candidate MEM1003. MEMY is trading up in late afternoon action 47 cents a share (thats up almost 20%) at $2.83. Monday MEMY traded up over 44%. The company has fully enrolled it's phase IIa clinical trial for MEM1003 which means a, they found enough people to run the study with mild to moderate disease; b, it tells investors that the company has confidence in the drug and will rather quickly know whether or not there is efficacy.
MEM1003 is a drug that targets L-type calcium channels in patients with Alzheimer's. Ongoing research strongly suggests that aging alters brain Ca2+ regulation, resulting in impaired neuronal function and, eventually, neurodegeneration.
Voltage-dependent Ca2+ currents and potentials are enhanced in neurons of aged experimental animals, and apparently are mediated by an increase in the membrane density of L-type voltage-sensitive Ca2+ channels. In addition, selective L-VSCC antagonists and other Ca2+ blockers can counteract the effects of aging on several aspects of neuronal and/or behavioral function, implying that channel activity may be necessary for the aging changes.
MEM1003 selectively blocks these channels and could help regulate calcium flow.
MEM1003 is a drug that targets L-type calcium channels in patients with Alzheimer's. Ongoing research strongly suggests that aging alters brain Ca2+ regulation, resulting in impaired neuronal function and, eventually, neurodegeneration.
Voltage-dependent Ca2+ currents and potentials are enhanced in neurons of aged experimental animals, and apparently are mediated by an increase in the membrane density of L-type voltage-sensitive Ca2+ channels. In addition, selective L-VSCC antagonists and other Ca2+ blockers can counteract the effects of aging on several aspects of neuronal and/or behavioral function, implying that channel activity may be necessary for the aging changes.
MEM1003 selectively blocks these channels and could help regulate calcium flow.
Monday, April 09, 2007
A new look is coming!
I intend to drop publishing the press releases from specific biotech companies and start looking at clinical trial data and moving stocks and expand from there, so there will be all original material from here on. I hope this makes the site more interesting and helpful at the same time. Any feedback on what I might be missing or what can make the site better, drop me an email.
Friday, April 06, 2007
ImClone Rallies on Erbitux News
A brief review of thursday's action; Markets closed today for Good Friday:
ImClone Systems and Bristol-Myers Squibb said Apr. 4 that their cancer drug Erbitux can improve the odds of survival in patients on chemotherapy whose head and neck cancers have spread. Investors bid up ImClone's stock nearly 5% to $42.49 on the Nasdaq, while Bristol-Myers Squibb, which is responsible for most of Erbitux's development and marketing costs, rose 0.9% to $27.78. What does this mean?
What is Erbitux and how does it work?
Erbitux is a humanized monoclonal antibody to the epidermal growth factor receptor (EGFR). The family of EGFRs include EGFR, HER2, HER3 and HER4. These receptors mediate and modulate the growth and differentiation of many cell types within the body. Specifically, [and in other cancers] it has been shown that in breast cancers, HER2 and EGFR are over-expressed and are a prognostic indicator of disease. Erbitux competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor alpha. Binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production.
IMCL closed thursdays trading up 45 cents per share to 42.94.
ImClone Systems and Bristol-Myers Squibb said Apr. 4 that their cancer drug Erbitux can improve the odds of survival in patients on chemotherapy whose head and neck cancers have spread. Investors bid up ImClone's stock nearly 5% to $42.49 on the Nasdaq, while Bristol-Myers Squibb, which is responsible for most of Erbitux's development and marketing costs, rose 0.9% to $27.78. What does this mean?
What is Erbitux and how does it work?
Erbitux is a humanized monoclonal antibody to the epidermal growth factor receptor (EGFR). The family of EGFRs include EGFR, HER2, HER3 and HER4. These receptors mediate and modulate the growth and differentiation of many cell types within the body. Specifically, [and in other cancers] it has been shown that in breast cancers, HER2 and EGFR are over-expressed and are a prognostic indicator of disease. Erbitux competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor alpha. Binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production.
IMCL closed thursdays trading up 45 cents per share to 42.94.
Thursday, April 05, 2007
News--Celgene Shares Jump on Revlimid Outlook
I will post more on how the drug works in a bit.........
Celgene Shares Gain on Positive Study and Market Outlook for Revlimid
NEW YORK (AP) -- Shares of biopharmaceutical company Celgene Corp. jumped Thursday on positive news that its cancer treatment Revlimid could be beneficial for multiple myeloma patients.
Shares of Celgene gained $1.83, or 3.3 percent, to $57.31 in afternoon trading on the Nasdaq Stock Market. The stock has traded between $36.02 and $60.12 over the last 52 weeks, and is off nearly 4 percent since the start of the year.
The drug was first approved to treat anemia and then to treat multiple myeloma, or blood cancer, in combination with the steroid dexamethasone. But that second approval is for patients who have already at least one prior treatment. A study released Wednesday by The Eastern
Cooperative Oncology Group said the drug improved survival rates, in combination with lower-than-normal doses of steroids for recently diagnosed patients.
In March the European Medicines Agency gave the drug a positive recommendation for approval.
Full results of the recent study will be presented at American Society of Clinical Oncology's June conference.
Merrill Lynch analyst Thomas McGahren reaffirmed a "Buy" rating with a $73 price target, suggesting upside of 31.5 percent over the stock's closing price Wednesday of $55.60, citing the research.
"We look for final results of the ECOG trial at ASCO in June, but it appears that a standard of care front-line treatment of Revlimid plus low-dose dex (dexamethasone) is taking shape," he wrote in a note to investors.
Piper Jaffray analyst Rachel L. McMinn reaffirmed a "Outperform" rating and boosted her price target to $68 from $63, also citing the study and drug's potential future market position.
"We expect the results will have a profound impact on the market acceptance for Revlimid -in combination with L-Dex- as a cornerstone of myeloma therapy," she wrote.
Other analysts reaffirmed positive outlooks including Lazard Capital Markets with a "Buy" rating and $70 price target.
Celgene Shares Gain on Positive Study and Market Outlook for Revlimid
NEW YORK (AP) -- Shares of biopharmaceutical company Celgene Corp. jumped Thursday on positive news that its cancer treatment Revlimid could be beneficial for multiple myeloma patients.
Shares of Celgene gained $1.83, or 3.3 percent, to $57.31 in afternoon trading on the Nasdaq Stock Market. The stock has traded between $36.02 and $60.12 over the last 52 weeks, and is off nearly 4 percent since the start of the year.
The drug was first approved to treat anemia and then to treat multiple myeloma, or blood cancer, in combination with the steroid dexamethasone. But that second approval is for patients who have already at least one prior treatment. A study released Wednesday by The Eastern
Cooperative Oncology Group said the drug improved survival rates, in combination with lower-than-normal doses of steroids for recently diagnosed patients.
In March the European Medicines Agency gave the drug a positive recommendation for approval.
Full results of the recent study will be presented at American Society of Clinical Oncology's June conference.
Merrill Lynch analyst Thomas McGahren reaffirmed a "Buy" rating with a $73 price target, suggesting upside of 31.5 percent over the stock's closing price Wednesday of $55.60, citing the research.
"We look for final results of the ECOG trial at ASCO in June, but it appears that a standard of care front-line treatment of Revlimid plus low-dose dex (dexamethasone) is taking shape," he wrote in a note to investors.
Piper Jaffray analyst Rachel L. McMinn reaffirmed a "Outperform" rating and boosted her price target to $68 from $63, also citing the study and drug's potential future market position.
"We expect the results will have a profound impact on the market acceptance for Revlimid -in combination with L-Dex- as a cornerstone of myeloma therapy," she wrote.
Other analysts reaffirmed positive outlooks including Lazard Capital Markets with a "Buy" rating and $70 price target.
Wednesday, April 04, 2007
IDI Pharma Inc.Rockets up on FDA meeting
IDI Pharma Inc. ( IDMI8.25, +3.00, +57.1%) shares soared after the company said during Tuesday's session that the Food and Drug Administration has scheduled an Oncologic Drugs Advisory Committee meeting on May 9 to discuss Junovan. IDM Pharma has filed a new drug application for Junovan to treat patients with newly diagnosed resectable high grade osteosarcoma following surgical resection in combination with multiple agent chemotherapy.
Resectable high grade osteosarcoma is bone cancer that can be operated on or partially removed. Junovan stimulates the immune system by activating immune cells called macrophages. The drug is actually a derivative of bacterial cell walls and this is how it activates the immune system. How it works is [very simply] is to activate the macrophage which in turn releases cytokines that further manifest the immune response.
Junovan has orphan drug status in the U.S. and Europe.
IDMI is trading in mid-afternoon up 55% to $8.18, that's 2.93 a share.
Resectable high grade osteosarcoma is bone cancer that can be operated on or partially removed. Junovan stimulates the immune system by activating immune cells called macrophages. The drug is actually a derivative of bacterial cell walls and this is how it activates the immune system. How it works is [very simply] is to activate the macrophage which in turn releases cytokines that further manifest the immune response.
Junovan has orphan drug status in the U.S. and Europe.
IDMI is trading in mid-afternoon up 55% to $8.18, that's 2.93 a share.
Tuesday, April 03, 2007
Prostate drugs keep rolling: Cell Genesys gets positive data
Cell Genesys Stock Surges on Positive Follow Up Data for Prostate Cancer Drug Candidate
Shares of biotechnology company Cell Genesys Inc. jumped Tuesday on positive follow-up data from the company's prostate cancer drug candidate.
GVAX is akin to DNDN's product in that it serves as a vaccine for tumor formation. It primes the immune system to help fight against cancerous cells by using whole-cells designed to stimulate an immune response. The vaccines are comprised of tumor cells that have been genetically in the laboratory that are modified to secrete GM-CSF, [see DNDN from yesterday] an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines. I don't buy the skeptic saying the study numbers are too small. Always another angle.
CEGE closed today's trading up 32% per share to $5.70.
Shares of biotechnology company Cell Genesys Inc. jumped Tuesday on positive follow-up data from the company's prostate cancer drug candidate.
The stock gained $1.39, or 32.3 percent, to close at $5.70 on the Nasdaq Stock Market. Shares have traded between $2.77 and $8.10 over the last 52 weeks. Volume Tuesday neared 60.3 million shares, more than 58 times its normal trade.
The company said follow-up data from a mid stage clinical trial of GVAX showed patients survived longer. Cell Genesys is using the same dosage in its ongoing late-stage study of the drug.
JP Morgan analyst Richard Smith reaffirmed a "Neutral" rating on the stock citing the data and said the company is a longer term play, with Phase III clinical trial data expected in late 2008.
"In the meantime, we see close management of expenses as necessary to reach the goal line," he wrote in a note to investors.
Cell Genesys was also given a boost by the recent Food and Drug Administration panel endorsement of Dendreon Corp.'s prostate cancer vaccine Provenge, he said. The FDA is expected to make a decision on whether to approve that drug May 15.
Meanwhile, Canaccord Adams analyst Joseph Pantginis reaffirmed a "Buy" rating with a $7 price target, also citing Dendreon's good news.
The data update from Cell Genesys can also help the company in its partnering discussions, he wrote in a note to investors.
"We view this GVAX prostate survival update as a strong incremental positive for Cell Genesys that further solidifies our projection that GVAX Prostate will play an integral role in the treatment of prostate cancer," he wrote.
Some on Wall Street urged caution, however. Lehman Brothers analyst Jim Birchenough noted that the study showed promising results compared to the current standard of treatment, but added that the small number of patients involved and other issues may have biased the results. He pointed to a number of Phase II studies that showed positive results that didn't pan out under further testing. "Indeed with only 22 patients as a basis for GVAX analysis and no way to control for patient selection bias, we believe that GVAX survival data is more likely driven by better patient baseline status than specific drug effect," he wrote.
Birchenough reiterated an "Equal Weight" rating and $3 price target on the shares.
CEGE What is the product?GVAX is akin to DNDN's product in that it serves as a vaccine for tumor formation. It primes the immune system to help fight against cancerous cells by using whole-cells designed to stimulate an immune response. The vaccines are comprised of tumor cells that have been genetically in the laboratory that are modified to secrete GM-CSF, [see DNDN from yesterday] an immune stimulatory hormone that plays a key role in stimulating the body's immune response to vaccines. I don't buy the skeptic saying the study numbers are too small. Always another angle.
CEGE closed today's trading up 32% per share to $5.70.
Monday, April 02, 2007
Dendreon Continues to Gain on FDA Recommendation for Prostate Cancer Drug Provenge
Dendreon Continues to Gain on FDA Recommendation for Prostate Cancer Drug Provenge
Shares of Dendreon Corp., which doubled Friday after the company's prostate cancer vaccine was endorsed by a Food and Drug Administration advisory panel, continued to climb in early trading Monday.
The panel said Dendreon's Provenge could be useful in treating advanced prostate cancer. A final FDA ruling is expected May 15, and the agency usually follows recommendations from its committees. Results from a larger trial of Provenge are expected in May 2008.
Dendreon focuses on cancer drugs. Its has several prostate cancer drugs in late-stage clinical trials, and treatments for ovarian, colorectal and breast cancers in earlier testing. Treatments for those cancers, as well as kidney and cervical cancer, are in preclinical testing.
Analysts for JMP Securities and Banc of America Securities raised their prices targets for Dendreon Friday, but Wall Street overall has mixed views about the Seattle-based company's future. Four analysts reporting to Thomson Financial rate Dendreon stock at "Neutral" or the equivalent, three rate shares at "Sell" or its equal, and two at "Buy" or the equivalent.
Dendreon shares rose as high as $13.87 in early trading on the Nasdaq Stock Market before edging back to a gain of 52 cents, or 4 percent, at $13.45.
The stock closed at $12.93 Friday, up from $5.22 the previous day. Shares set an all-time high of $18.05 during the Friday session.
How does Provenge work?-----This is really cool. They take special immune cells from your body and put them in the laboratory. They then take very precise proteins from cancer cells and growth factors to make the cells grow [dendritic cells--which are the cells the body use to fight cancers and infections. They incubate cancer proteins with the cells basically to piss the cells off! Then they put the pissed off cells back into the patient and let them go to work! Bam.
DNDN is still trading up $1.52 (thats 11.7%) per share at 14.50.
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