So you missed out on former biotech penny stocks, such as DNDN, VNDA and HGSI and don’t what it to happen again or have an inclination of searching for that next big surge biotech penny stocks. Well, I am not going to say that these biotech penny stocks will be the next big thing, but it sure worth watching for the upcoming days/weeks.
During trading hours on Friday 8/28/2009, these penny (under $2) biotech stocks showed unusual surge and moving above their resistance levels of 100, 50 and recently 10 days trading averages with significant volume comparable to total volume behind the upward trend. As always do your homework it’s a jungle out there, now go and play!
1. Encorium group inc (biotech ticker: ENCO)
(current:0.260) 44% up with 2.2 million volume
2.Helicos BioSciences Corp.(biotech ticker:HLCS)
(current:1.75) 37% up with 6 million volume
3. Curis, inc (biotech ticker: CRIS)
(current:1.99) 20% 4.5 million volume
4. Bionovo inc (biotech ticker: BNVI)
(current:0.665) 18% up with 1/2 million volume
5. Uluru inc (biotech ticker: ULU) (current:0.197) 17% up with 6 million volume
Sunday, August 30, 2009
Friday, August 28, 2009
Second time around for SPPI ?
Let's take a second look at biotech, SPPI: Recall back on June 29-30 volume moved above 5 millions and closed price $7.6 respectively 3 days prior to SPPI July 2nd FDA action date Thursday. Everyone knows, priced dropped two days prior, profit taking, risk mitigation or whatever you call it, if it's not approved. PPS further dropped again as actual news released. So, here we are at it again, price moved above resistance levels with good volume in anticipation for Zevalin getting the nod from the FDA. The question being raised, will this time around be any resemblance that of the last? To answer let's speculate on now vs then question.
1. This time huge action, volume and price over resistance levels 6
days prior to action date vs 4 days last time?
2. This is the second time around with all data are in, second time
the charm, less risky vs the first time?
3. Potential in sales of Zevalin are more established vs last time?
4. SPPI's leading product now has fast track vs no news last time?
5. SPPI enhanced their impressive pipelines and compound by acquired
total rights Renazorb and Renalan
6. Fusilev FDA action date Oct 8th which is 2 months closer now vs then
With more factors are now known vs back then, and as a biotech, SPPI
being a speculative play. The more known, the more the price will
reflect upon it. However, will investors' trading impulses and mm and
hedge fund risky leverages on day trading will fair on SPPI this time
around? Will trading similar to that of the last or this time is
different some new facts are in leading to FDA approval? Will have to
wait and see, now let's go and play.
1. This time huge action, volume and price over resistance levels 6
days prior to action date vs 4 days last time?
2. This is the second time around with all data are in, second time
the charm, less risky vs the first time?
3. Potential in sales of Zevalin are more established vs last time?
4. SPPI's leading product now has fast track vs no news last time?
5. SPPI enhanced their impressive pipelines and compound by acquired
total rights Renazorb and Renalan
6. Fusilev FDA action date Oct 8th which is 2 months closer now vs then
With more factors are now known vs back then, and as a biotech, SPPI
being a speculative play. The more known, the more the price will
reflect upon it. However, will investors' trading impulses and mm and
hedge fund risky leverages on day trading will fair on SPPI this time
around? Will trading similar to that of the last or this time is
different some new facts are in leading to FDA approval? Will have to
wait and see, now let's go and play.
Tuesday, August 25, 2009
Update: Small Cap Biotech Important FDA Action Dates for September
Here are the FDA action dates for September, enjoy and now go play!
Sept. 1
-FDA advisory Committee meets to review Vion Pharmaceuticals' (biotech ticker: VION) Onrigin, drug for treatment of acute myeloid leukemia.
Sept. 2
-FDA advisory Committee meets to review Allos Therapeutics' (biotech ticker: ALTH) pralatrexate, drug for treatment of lymphoma.
-FDA approval action date for Endo Pharmaceuticals' (biotech ticker: ENDP) Nebido, a long-acting testosterone replacement therapy.
Sept. 7
-FDA approval action date for Spectrum Pharmaceuticals' (biotech ticker: SPPI) Zevalin, a drug for non-Hodgkin's lymphoma.
Sept. 11
-FDA approval action date for Salix Pharmaceuticals’ (biotech ticker: SLXP) Metozolv (Metoclopramide), a drug for treatment of gastroesophageal reflux who fail to respond to conventional therapy
Sept. 12
-FDA approval action date for ISTA Pharmaceuticals’ (biotech ticker: ISTA) Bepreve, a drug for ocular itching associated with allergic conjunctivitis.
Sept. 16
-FDA Advisory Committee meets to review Auxilium Pharmaceutical's (biotech ticker:AUXL) Xiaflex for advanced Dupuytren's disease.
-FDA approval action date for Theravance's (biotech ticker: THRX) antibiotic Telavancin.
Sept. 24
-FDA approval action date for Eurand Pharmaceuticals' (biotech ticker: EURX) Zenpep, a drug for pancreatic insufficiency.
-FDA approval action date for Allos Therapeutics' (biotech ticker: ALTH) Pralatrexate, a drug for peripheral T-cell lymphoma.
Sept. 1
-FDA advisory Committee meets to review Vion Pharmaceuticals' (biotech ticker: VION) Onrigin, drug for treatment of acute myeloid leukemia.
Sept. 2
-FDA advisory Committee meets to review Allos Therapeutics' (biotech ticker: ALTH) pralatrexate, drug for treatment of lymphoma.
-FDA approval action date for Endo Pharmaceuticals' (biotech ticker: ENDP) Nebido, a long-acting testosterone replacement therapy.
Sept. 7
-FDA approval action date for Spectrum Pharmaceuticals' (biotech ticker: SPPI) Zevalin, a drug for non-Hodgkin's lymphoma.
Sept. 11
-FDA approval action date for Salix Pharmaceuticals’ (biotech ticker: SLXP) Metozolv (Metoclopramide), a drug for treatment of gastroesophageal reflux who fail to respond to conventional therapy
Sept. 12
-FDA approval action date for ISTA Pharmaceuticals’ (biotech ticker: ISTA) Bepreve, a drug for ocular itching associated with allergic conjunctivitis.
Sept. 16
-FDA Advisory Committee meets to review Auxilium Pharmaceutical's (biotech ticker:AUXL) Xiaflex for advanced Dupuytren's disease.
-FDA approval action date for Theravance's (biotech ticker: THRX) antibiotic Telavancin.
Sept. 24
-FDA approval action date for Eurand Pharmaceuticals' (biotech ticker: EURX) Zenpep, a drug for pancreatic insufficiency.
-FDA approval action date for Allos Therapeutics' (biotech ticker: ALTH) Pralatrexate, a drug for peripheral T-cell lymphoma.
Sunday, August 23, 2009
All eyes on ARIAD this time around?
Remember Ariad Pharmaceuticals,Inc (Biotech Ticker: ARIA)run up started back in June 22 til late July, that's almost doubled in price from 1.58 to 2.8 in speculated news of the Rida Phase III interim data results to report in 2Q, well, it never happened. Ariad didn't report any result data. Well, we are at it again in 3Q speculating that Ariad is going to report the data result, let's take a closer look, if this time around is on purely speculative or something is brewing for major break out?
1. Recent News of the US appeal court reconsider the patent dispute,which in favor of Ariad, if awarded, $65 million plus royalties and back royalties of the billion dollar drug;Evista.
2. With "outperform" rating by Oppenheimer and price target of $4.00.
3. CEO bought 1.7million shares on 08/04/2009 at an average price of $1.9.
4. Positive data results on Phase II on their flagship drug,Rida treatment of sarcoma, and most analysts speculate that these data will carry over to Interim Phase III, which will be announced in 3Q if not sooner.
5. Partnership with Merck not only for Sarcoma, but in other Phase II of multi-cancer treatment settings.
On the flip side there has been an increasing number of short sellers on recent months and on key dates, Sept 9,Sept 30th. However, with trading volume increasing steadily in recent months, July 60 million, August 69 million, and in recent week moved and closed above barrier point of 1.80 on August 13, recently moving pass 2.05 and above 10,30 and 50 days moving averages and closed at 2.12 on August 21 2009.
So is this stock on the verge of major breakout? All speculative news are out, factual news are in and technical trends pointing in an uptrend direction. It will be a huge surprise not to see this stock break out in a few weeks, but in what direction? One can only speculate but it's well worth to keep your eye out for this one.
1. Recent News of the US appeal court reconsider the patent dispute,which in favor of Ariad, if awarded, $65 million plus royalties and back royalties of the billion dollar drug;Evista.
2. With "outperform" rating by Oppenheimer and price target of $4.00.
3. CEO bought 1.7million shares on 08/04/2009 at an average price of $1.9.
4. Positive data results on Phase II on their flagship drug,Rida treatment of sarcoma, and most analysts speculate that these data will carry over to Interim Phase III, which will be announced in 3Q if not sooner.
5. Partnership with Merck not only for Sarcoma, but in other Phase II of multi-cancer treatment settings.
On the flip side there has been an increasing number of short sellers on recent months and on key dates, Sept 9,Sept 30th. However, with trading volume increasing steadily in recent months, July 60 million, August 69 million, and in recent week moved and closed above barrier point of 1.80 on August 13, recently moving pass 2.05 and above 10,30 and 50 days moving averages and closed at 2.12 on August 21 2009.
So is this stock on the verge of major breakout? All speculative news are out, factual news are in and technical trends pointing in an uptrend direction. It will be a huge surprise not to see this stock break out in a few weeks, but in what direction? One can only speculate but it's well worth to keep your eye out for this one.
Thursday, August 20, 2009
No News is Good News on Biotech CTIC Surge?
In the past couple of days Cell Therapeutics (biotech ticker: CTIC) stock has jumped up over 10% with huge volume of 84 million shares but pulled back today of 5% of about 45 million shares in volume and closed at $1.65 of what appeared to be no news. Is this the case of anticipated news is the news? Most anticipates on news of CTIC application for FDA priority review of their flagship drug, Pixantron, which filed on June 24th 2009 to be announced. According to FDA policy, after the company filed for priority review, FDA will determine it’s destination within 45 days. Since CTIC filed Pixantron on June 24th that would make decision already be made already in the first week of August, but no news. Therefore, one can only speculate that news will come within 45 business days, since federal agency only operates on business day, so that would make it August 26th to be the last day for the FDA decision and the company to be announced within 3 days of the any news.
With huge volume recently and $30 million institution investment on board fueled even more speculations that FDA decision has already been made and that the company to announce the decision on Monday August 24th.
With huge volume recently and $30 million institution investment on board fueled even more speculations that FDA decision has already been made and that the company to announce the decision on Monday August 24th.
Monday, August 17, 2009
A few positive biotechs upbeat amidst negative Monday sentiment in the broader market
Shares of Ariad Pharmaceuticals Inc. (biotech ticker:ARIA) rose as much as 10% to 2.16 in early hour trading on Monday and settled 2.08 (7%) at end of trading day after analysis stated the company’s leading multi-treatment drug candidate, Ridaforolimus has good prospects for eventual FDA approval. Also, Oppenheimer initiated the stock with an "Outperform" rating and a $4 price target.
Shares of Protalix Biotherapeutics Inc (biotech ticker:PLX) up 30% pre-market trading and settled at 6.39 from Friday close of 5.77, after FDA approved treatment protocol for Gaucher disease drug.
Keryx Biopharmaceuticals, Inc. (biotech ticker:KERX) shares also climbed in that latter day of trading and closed up 8% at 1.46. The company freed up 13.4million in cash from cost cutting in operating expenses and from other security investments. Also, the company leading drug candidate, Periforisine; treatment for Multiple Myeloma, received FDA nod for the critical phase III trial protocols.
BioSante Pharmaceuticals, Inc. (biotech ticker:BPAX) shares rose 25% in early trading after company said that its adjuvant increased the efficacy of vaccines designed to guard against various flu strains, including swine flu
Vion Pharmaceuticals, Inc. (biotech ticker:VION) shares up 5% as investors speculate on the September 1st Oncologic Drugs Advisory Committee (ODAC) vote for their cancer treating drug Onrigin(TM).
Shares of Protalix Biotherapeutics Inc (biotech ticker:PLX) up 30% pre-market trading and settled at 6.39 from Friday close of 5.77, after FDA approved treatment protocol for Gaucher disease drug.
Keryx Biopharmaceuticals, Inc. (biotech ticker:KERX) shares also climbed in that latter day of trading and closed up 8% at 1.46. The company freed up 13.4million in cash from cost cutting in operating expenses and from other security investments. Also, the company leading drug candidate, Periforisine; treatment for Multiple Myeloma, received FDA nod for the critical phase III trial protocols.
BioSante Pharmaceuticals, Inc. (biotech ticker:BPAX) shares rose 25% in early trading after company said that its adjuvant increased the efficacy of vaccines designed to guard against various flu strains, including swine flu
Vion Pharmaceuticals, Inc. (biotech ticker:VION) shares up 5% as investors speculate on the September 1st Oncologic Drugs Advisory Committee (ODAC) vote for their cancer treating drug Onrigin(TM).
Sunday, August 16, 2009
Small Cap Biotech with Large September FDA Action Date
Allos Therapeutics, Inc (biotech ticker: ALTH)
Drug: Pralatrexate is intended as a treatment for T-cell lymphoma that has recurred or not responded to other drugs.
FDA Committee to vote September 2 2009
FDA action Date: September 24th 2009
Salix Pharmaceuticals, Ltd. (biotech ticker:SLXP)
Drug: Metozolv (Metoclopramide) fast–dissolving formulation of metoclopramide, acquisition from Wilmington Pharmaceuticals in September 2007. an Oral disintegrating tablet (ODT) formulation of metoclopramide, for the treatment of short–term therapy (4–12 weeks) for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis
FDA action date: September 11th 2009
ISTA Pharmaceuticals, Inc. (biotech ticker: ISTA)
Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5% as an eye drop treatment for ocular itching associated with allergic conjunctivitis. June 26 2009; FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee recommended the approval of Bepreve 7-0 in favor.
FDA action date: September 12th 2009
Drug: Pralatrexate is intended as a treatment for T-cell lymphoma that has recurred or not responded to other drugs.
FDA Committee to vote September 2 2009
FDA action Date: September 24th 2009
Salix Pharmaceuticals, Ltd. (biotech ticker:SLXP)
Drug: Metozolv (Metoclopramide) fast–dissolving formulation of metoclopramide, acquisition from Wilmington Pharmaceuticals in September 2007. an Oral disintegrating tablet (ODT) formulation of metoclopramide, for the treatment of short–term therapy (4–12 weeks) for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy and for the relief of symptoms associated with acute and recurrent diabetic gastroparesis
FDA action date: September 11th 2009
ISTA Pharmaceuticals, Inc. (biotech ticker: ISTA)
Drug: Bepreve (bepotastine besilate ophthalmic solution) 1.5% as an eye drop treatment for ocular itching associated with allergic conjunctivitis. June 26 2009; FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee recommended the approval of Bepreve 7-0 in favor.
FDA action date: September 12th 2009
Thursday, August 13, 2009
Small Biotech Makers with Big Blockbuster Drugs
1. Parkinson
A chronic neurological condition due to the degeneration of neurons in the brain that controls movement. American Parkinson's Disease Association indicated that there are approximately 1.5 million people in the United States suffer from this disease. Studies have suggested that up to 40 percent of patients with Parkinson's disease will develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. Currently there is no therapy in the United States approved to treat Parkinson's disease
psychosis. Researchers estimated that the annual economic burden associated with Parkinson’s disease (PD) in the United States to far exceed $25 billion.
Small Biotech Makers
Acadia Pharmaceuticals (biotech ticker: acad)
Drug: Pimavanserin is a small molecule product candidate that we discovered and have advanced to Phase III development as a treatment for patients with Parkinson's disease psychosis. In collaboration with Biobail, Acadia completed enrollment in the first pivotal Phase III trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in May 2009.
UPDATED: ACADIA expects to report top-line results from this trial in the third quarter of 2009(Sept30th). (November 5,2009 report date)
2. Obesity/Diabetes
Obesity- The prevalence of obesity continues to be a health concern and affects a large and growing proportion of the population, including over 30% (more than 60 million) of Americans. Worldwide more than 300 million people are obese. Obesity directly contributes to numerous life-threatening conditions: diabetes, cardiovascular disease, hypertension and stroke. Presently there are a number of anti-obesity agents in clinical development.
The worldwide obesity therapeutic market is currently estimated to be approximately $1 billion. Analysts speculate that the potential market for obesity in the United States could approach $5 billion.
Diabetes- There are 23.6 million children and adults in the United States, or 7.8% of the population, who have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, unfortunately, 5.7 million people (or nearly one quarter) are unaware that they have the disease. It is estimated that there are nearly 250 million diabetics worldwide. New cases of diabetes doubled over the last ten years due to obesity and lifestyle and it is now calculated that the lifetime risk of diabetes in this century is approximately 35%.
Analysts speculate that the market for an effective diabetes treatment could have multi-billion-dollar annual sales potential.
Small Biotech Makers:
VIVUS, Inc. (biotech ticker:VVUS)
Drug: Qnexa in treatment of obesity (phase III) and diabetes (Phase II). Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax) obesity candidate under development today. EQUIP and CONQUER data on track for mid-2009 year end.
Update: Vivus expects to announce Phase III Qnexa result in 3Q 2009 (Nov 4th 2009 report date)
3. Breathing
Asthma and COPD are the two most common respiratory diseases. According to data 7 percent of adults and 9 percent of children have asthma. . In 2004, approximately 4.2 percent of people in the U.S. had at least one asthma attack. Data from a national health survey shows around 24 million Americans are affected by the disease. About $20.2 billion will be spent on asthma medications in the U.S. per year. At the American Thoracic Society International Conference, it is estimated, over the next 20 years, medical costs related to chronic obstructive pulmonary disease (COPD) will total approximately $832.9 billion in the United States. There are currently no drug in the market that are being used treatment of COPD and Asthma in combination and of single dose application.
The most commonly prescribed asthma drug is Advair from GlaxoSmithKline's with projected sales of $7.4 billion. Another drug is Merck & Co's Singular. The common
COPD drug is Combivent/Atrovent/Spiriva by Boehringer Ingelheim Pharmaceuticals, Inc. However there is a lack of a single dose drug that can target the two diseases condition effectively.
Small Biotech Makers:
Theravance Inc (biotech ticker:THRX)
Drug: Fluticasone furoate, developed by GlaxoSmithKline, in partnership with Theravance Inc. The two companies are working on a potential follow-up to Advair. Glaxo and Theravance announced results of three separate Phase IIb studies of the candidate across a range of eight doses in more than 1,800 patients. Fluticasone furoate was effective in all but the lowest dose tested. Only the highest dose showed a statistically significant boost in a side effect typical of its type of inhaled steroid.
UPDATE: GSK currently expects to initiate the Phase 3 program in COPD in October of 2009.
A chronic neurological condition due to the degeneration of neurons in the brain that controls movement. American Parkinson's Disease Association indicated that there are approximately 1.5 million people in the United States suffer from this disease. Studies have suggested that up to 40 percent of patients with Parkinson's disease will develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. Currently there is no therapy in the United States approved to treat Parkinson's disease
psychosis. Researchers estimated that the annual economic burden associated with Parkinson’s disease (PD) in the United States to far exceed $25 billion.
Small Biotech Makers
Acadia Pharmaceuticals (biotech ticker: acad)
Drug: Pimavanserin is a small molecule product candidate that we discovered and have advanced to Phase III development as a treatment for patients with Parkinson's disease psychosis. In collaboration with Biobail, Acadia completed enrollment in the first pivotal Phase III trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP) in May 2009.
UPDATED: ACADIA expects to report top-line results from this trial in the third quarter of 2009(Sept30th). (November 5,2009 report date)
2. Obesity/Diabetes
Obesity- The prevalence of obesity continues to be a health concern and affects a large and growing proportion of the population, including over 30% (more than 60 million) of Americans. Worldwide more than 300 million people are obese. Obesity directly contributes to numerous life-threatening conditions: diabetes, cardiovascular disease, hypertension and stroke. Presently there are a number of anti-obesity agents in clinical development.
The worldwide obesity therapeutic market is currently estimated to be approximately $1 billion. Analysts speculate that the potential market for obesity in the United States could approach $5 billion.
Diabetes- There are 23.6 million children and adults in the United States, or 7.8% of the population, who have diabetes. While an estimated 17.9 million have been diagnosed with diabetes, unfortunately, 5.7 million people (or nearly one quarter) are unaware that they have the disease. It is estimated that there are nearly 250 million diabetics worldwide. New cases of diabetes doubled over the last ten years due to obesity and lifestyle and it is now calculated that the lifetime risk of diabetes in this century is approximately 35%.
Analysts speculate that the market for an effective diabetes treatment could have multi-billion-dollar annual sales potential.
Small Biotech Makers:
VIVUS, Inc. (biotech ticker:VVUS)
Drug: Qnexa in treatment of obesity (phase III) and diabetes (Phase II). Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax) obesity candidate under development today. EQUIP and CONQUER data on track for mid-2009 year end.
Update: Vivus expects to announce Phase III Qnexa result in 3Q 2009 (Nov 4th 2009 report date)
3. Breathing
Asthma and COPD are the two most common respiratory diseases. According to data 7 percent of adults and 9 percent of children have asthma. . In 2004, approximately 4.2 percent of people in the U.S. had at least one asthma attack. Data from a national health survey shows around 24 million Americans are affected by the disease. About $20.2 billion will be spent on asthma medications in the U.S. per year. At the American Thoracic Society International Conference, it is estimated, over the next 20 years, medical costs related to chronic obstructive pulmonary disease (COPD) will total approximately $832.9 billion in the United States. There are currently no drug in the market that are being used treatment of COPD and Asthma in combination and of single dose application.
The most commonly prescribed asthma drug is Advair from GlaxoSmithKline's with projected sales of $7.4 billion. Another drug is Merck & Co's Singular. The common
COPD drug is Combivent/Atrovent/Spiriva by Boehringer Ingelheim Pharmaceuticals, Inc. However there is a lack of a single dose drug that can target the two diseases condition effectively.
Small Biotech Makers:
Theravance Inc (biotech ticker:THRX)
Drug: Fluticasone furoate, developed by GlaxoSmithKline, in partnership with Theravance Inc. The two companies are working on a potential follow-up to Advair. Glaxo and Theravance announced results of three separate Phase IIb studies of the candidate across a range of eight doses in more than 1,800 patients. Fluticasone furoate was effective in all but the lowest dose tested. Only the highest dose showed a statistically significant boost in a side effect typical of its type of inhaled steroid.
UPDATE: GSK currently expects to initiate the Phase 3 program in COPD in October of 2009.
Small Cap Biotech Pharma in Phase III
ACADIA Pharmaceuticals (biotech ticker:ACAD)
Phase III: Pimavanserin development for Parkinson's disease psychosis in collaboration with Biovail. ACADIA completed enrollment in the first pivotal Phase III trial of Pimavanserin in patients with Parkinson’s disease psychosis (PDP) in May 2009.
UPDATED: ACADIA expects to report top-line results from this trial in the third quarter of 2009 (November 5 2009).
ARIAD Pharmaceuticals, Inc. (biotech ticker:ARIA)
Phase III: Ridaforolimus in treatment for Sarcoma. ARIAD is collaborating with Merck & Co., Inc. (“Merck”) to globally develop and commercialize ridaforolimus
Medivation, Inc. (biotech ticker: MDVN)
Phase III: Dimebon an investigational drug for treatment in patitients with Huntington disease.
Update: July 30, 2009. Pfizer Inc (biotech ticker:PFE) and Medivation, Inc. (biotech ticker:MDVN) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease.
Amicus Therapeutics (biotech ticker:FOLD)
Phase III: Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease
Update: June 23, 2009. Amicus Therapeutics today announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease.
Oncothyreon Inc (biotech ticker:ONTY)
Phase III: Stimuvax(R) treatment of metastatic breast cancer
June 22, 2009. Today announced that Merck KGaA of Darmstadt, Germany, has initiated a global Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine, L-BLP25) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
OSI Pharmaceuticals, Inc. (biotech ticker:OSIP)
Phase III: Tarceva in treatment of patients with advanced non-small cell lung cancer (NSCLC)
Update: August 3, 2009, announced further results from the Phase III SATURN study showing that Tarceva extended the survival of patients with advanced non-small cell lung cancer (NSCLC) when used as single agent, maintenance therapy in patients who did not progress following first-line treatment with platinum-based chemotherapy.
VIVUS, Inc.(biotech ticker:VVUS)
Phase III: Qnexa in treatment of obesity
Update: Jul 7, 2009, Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax) obesity candidate under development today. EQUIP and CONQUER data on track for mid-2009 year end.
Orexigen Therapeutics, Inc. (biotech ticker:OREX)
Phase III: Contrave investigational drug for the treatment of obesity, met their co-primary endpoints
Update: July 20, 2009. OREX announced that all three remaining Phase 3 trials evaluating Contrave(R), its investigational drug for the treatment of obesity, met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first half of 2010.,
MAP Pharmaceuticals, Inc. (biotech ticker:MAPP)
Phase III: Levadex, novel in treatment of migraine
Update: May 26, 2009. MAP Pharmaceuticals, Inc. (MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX(TM) orally inhaled migraine therapy met all four primary endpoints.
Avanir Pharmaceuticals(biotech ticker:AVNR)
Phase III: Zenvia drug reduced emotional outbursts tied to a little-known neurological disorder, meeting the main goal of a late-stage study.
Update: Aug 11, 2009 drug to treat pseudobulbar affect met its primary efficacy endpoint in a Phase III trial
Halozyme Therapeutics, Inc. (biotech ticker:HALO)
Phase III: GAMMAGARD LIQUID with rHuPH20 for the treatment of primary immunodeficiency disorder
Update: Aug 07, 2009. Patient enrollment has been completed in the Phase 3 pivotal study of GAMMAGARD LIQUID with rHuPH20 for the treatment of primary immunodeficiency disorder
Keryx Biopharmaceuticals, Inc. (biotech ticker:KERX)
Phase III:
Update: August 3, 2009. announced today that it has reached agreement with the U.S. FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (VELCADE((R)))
Osiris Therapeutics, Inc. (biotech ticker:OSIR)
Phase III: Prochymal
Update: Prochymal is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn's disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA)
Inspire Pharmaceuticals, Inc (biotech ticker:ISPH)
Phase III: Denufosol for CF
Update: August 04, 2009. Inspire just reported positive phase III data of Denufosol for CF. Company has a strong collaborative alliance with Allergan Pharmaceuticals for key products that treat dry eyes and allergic conjunctivitis
Vical Incorporated (biotech ticker:VICL)
Phase 3: Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma,
Isis Pharmaceuticals, Inc. (biotech ticker:ISIS)
Phase III: of mipomersen, a novel lipid-lowering drug
Update: Aug 2008 (biotech ticker:GENZ) and Isis Pharmaceuticals, Inc. (biotech ticker:ISIS) announced that they have begun a phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH), a genetic disorder that causes exceptionally high levels of LDL cholesterol. It is the first of four new trials the companies plan to initiate by the end of this year, and the second late-stage study of mipomersen, a novel lipid-lowering drug that utilizes antisense technology. The primary endpoint will be percent reduction in LDL cholesterol, and data are expected to be available in 2010
Dyax Corp (biotech ticker:DYAX)
Phase III: DX-88 in the treatment of hereditary angioedema (HAE)
Update: The second Phase 3 trial, EDEMA4, was conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.
JAZZ Pharmaceutical (biotech ticker:JAZZ)
Phase III: JZP-6 (sodium oxybate) to address three important symptoms of fibromyalgia: pain, fatigue and sleep disturbances
Update: On June 24, 2009, Jazz Pharmaceuticals announced that the results of its second Phase III clinical trial of the JZP-6 product candidate were positive and consistent with the results of the first Phase III study, and that JZP-6 achieved its primary endpoint in both Phase III studies. New Drug Applications is expected to be submitted to the Food and Drug Administration later this year for JZP-6.
Phase III: Pimavanserin development for Parkinson's disease psychosis in collaboration with Biovail. ACADIA completed enrollment in the first pivotal Phase III trial of Pimavanserin in patients with Parkinson’s disease psychosis (PDP) in May 2009.
UPDATED: ACADIA expects to report top-line results from this trial in the third quarter of 2009 (November 5 2009).
ARIAD Pharmaceuticals, Inc. (biotech ticker:ARIA)
Phase III: Ridaforolimus in treatment for Sarcoma. ARIAD is collaborating with Merck & Co., Inc. (“Merck”) to globally develop and commercialize ridaforolimus
Medivation, Inc. (biotech ticker: MDVN)
Phase III: Dimebon an investigational drug for treatment in patitients with Huntington disease.
Update: July 30, 2009. Pfizer Inc (biotech ticker:PFE) and Medivation, Inc. (biotech ticker:MDVN) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease.
Amicus Therapeutics (biotech ticker:FOLD)
Phase III: Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease
Update: June 23, 2009. Amicus Therapeutics today announced it has commenced the U.S. registration Phase 3 trial with its investigational drug, Amigal(TM) (migalastat hydrochloride) for the treatment of Fabry disease.
Oncothyreon Inc (biotech ticker:ONTY)
Phase III: Stimuvax(R) treatment of metastatic breast cancer
June 22, 2009. Today announced that Merck KGaA of Darmstadt, Germany, has initiated a global Phase 3 trial of Stimuvax(R) (BLP25 liposome vaccine, L-BLP25) in patients with hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer.
OSI Pharmaceuticals, Inc. (biotech ticker:OSIP)
Phase III: Tarceva in treatment of patients with advanced non-small cell lung cancer (NSCLC)
Update: August 3, 2009, announced further results from the Phase III SATURN study showing that Tarceva extended the survival of patients with advanced non-small cell lung cancer (NSCLC) when used as single agent, maintenance therapy in patients who did not progress following first-line treatment with platinum-based chemotherapy.
VIVUS, Inc.(biotech ticker:VVUS)
Phase III: Qnexa in treatment of obesity
Update: Jul 7, 2009, Qnexa is a combination of two existing drugs, phentermine and topiramate (marketed for epilepsy and migraine as Topamax) obesity candidate under development today. EQUIP and CONQUER data on track for mid-2009 year end.
Orexigen Therapeutics, Inc. (biotech ticker:OREX)
Phase III: Contrave investigational drug for the treatment of obesity, met their co-primary endpoints
Update: July 20, 2009. OREX announced that all three remaining Phase 3 trials evaluating Contrave(R), its investigational drug for the treatment of obesity, met their co-primary endpoints. The results from the successfully completed Contrave Obesity Research, or COR, program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company's plan to file a New Drug Application (NDA) with the US Food and Drug Administration (FDA) in the first half of 2010.,
MAP Pharmaceuticals, Inc. (biotech ticker:MAPP)
Phase III: Levadex, novel in treatment of migraine
Update: May 26, 2009. MAP Pharmaceuticals, Inc. (MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX(TM) orally inhaled migraine therapy met all four primary endpoints.
Avanir Pharmaceuticals(biotech ticker:AVNR)
Phase III: Zenvia drug reduced emotional outbursts tied to a little-known neurological disorder, meeting the main goal of a late-stage study.
Update: Aug 11, 2009 drug to treat pseudobulbar affect met its primary efficacy endpoint in a Phase III trial
Halozyme Therapeutics, Inc. (biotech ticker:HALO)
Phase III: GAMMAGARD LIQUID with rHuPH20 for the treatment of primary immunodeficiency disorder
Update: Aug 07, 2009. Patient enrollment has been completed in the Phase 3 pivotal study of GAMMAGARD LIQUID with rHuPH20 for the treatment of primary immunodeficiency disorder
Keryx Biopharmaceuticals, Inc. (biotech ticker:KERX)
Phase III:
Update: August 3, 2009. announced today that it has reached agreement with the U.S. FDA regarding a Special Protocol Assessment on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in relapsed or relapsed / refractory multiple myeloma patients previously treated with bortezomib (VELCADE((R)))
Osiris Therapeutics, Inc. (biotech ticker:OSIR)
Phase III: Prochymal
Update: Prochymal is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn's disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA)
Inspire Pharmaceuticals, Inc (biotech ticker:ISPH)
Phase III: Denufosol for CF
Update: August 04, 2009. Inspire just reported positive phase III data of Denufosol for CF. Company has a strong collaborative alliance with Allergan Pharmaceuticals for key products that treat dry eyes and allergic conjunctivitis
Vical Incorporated (biotech ticker:VICL)
Phase 3: Allovectin-7(r) Immunotherapeutic for Metastatic Melanoma,
Isis Pharmaceuticals, Inc. (biotech ticker:ISIS)
Phase III: of mipomersen, a novel lipid-lowering drug
Update: Aug 2008 (biotech ticker:GENZ) and Isis Pharmaceuticals, Inc. (biotech ticker:ISIS) announced that they have begun a phase 3 study of mipomersen in patients with heterozygous familial hypercholesterolemia (heFH), a genetic disorder that causes exceptionally high levels of LDL cholesterol. It is the first of four new trials the companies plan to initiate by the end of this year, and the second late-stage study of mipomersen, a novel lipid-lowering drug that utilizes antisense technology. The primary endpoint will be percent reduction in LDL cholesterol, and data are expected to be available in 2010
Dyax Corp (biotech ticker:DYAX)
Phase III: DX-88 in the treatment of hereditary angioedema (HAE)
Update: The second Phase 3 trial, EDEMA4, was conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.
JAZZ Pharmaceutical (biotech ticker:JAZZ)
Phase III: JZP-6 (sodium oxybate) to address three important symptoms of fibromyalgia: pain, fatigue and sleep disturbances
Update: On June 24, 2009, Jazz Pharmaceuticals announced that the results of its second Phase III clinical trial of the JZP-6 product candidate were positive and consistent with the results of the first Phase III study, and that JZP-6 achieved its primary endpoint in both Phase III studies. New Drug Applications is expected to be submitted to the Food and Drug Administration later this year for JZP-6.
Wednesday, August 5, 2009
Could ACADIA be the next HGSI?
Two ways to play biotech ticker: ACAD before announcement of potential blockbuster Phase III Result.
1. Buy in now and wait for the conference
This is somewhat of a risk, if result are not promising price will inevitably drop, however i believe in my opinion, the drop in PPS is not as substantial as compare to disapproval of the drug vs the potential HUGE pay off if the result is significant. Look at HGSI, and you can read their very impressive pipelines. http://www.acadia-pharm.com/pipeline/
2. Wait for conference and buy on the results
This is a little less risk and required some long and patience, If result aren't positive, price drop and a good opportunity to get in on a bargain, because acadia has a very impressive pipelines and strong partnership or all together move to the next biotech stock. If positive result buy in hold for long and will pay off til filing NDA AND FDA APPROVAL.
1. Buy in now and wait for the conference
This is somewhat of a risk, if result are not promising price will inevitably drop, however i believe in my opinion, the drop in PPS is not as substantial as compare to disapproval of the drug vs the potential HUGE pay off if the result is significant. Look at HGSI, and you can read their very impressive pipelines. http://www.acadia-pharm.com/pipeline/
2. Wait for conference and buy on the results
This is a little less risk and required some long and patience, If result aren't positive, price drop and a good opportunity to get in on a bargain, because acadia has a very impressive pipelines and strong partnership or all together move to the next biotech stock. If positive result buy in hold for long and will pay off til filing NDA AND FDA APPROVAL.
Tuesday, August 4, 2009
Upcoming Biotech FDA Date for August 2009
I've put together an August '09 calender for the expected upcoming biotech FDA Decisions.
FDA Approval decision on a drug is a tremendous impact and huge significance for any biotech pharma, especially small cap biotech, for their years of research,labor and costs. Therefore, these FDA approval dates can be a make or break day for the company and demand great interest from investors for their company future valuation for the potential drug.
Nuvo Research Inc (biotech ticker: NRIFF)& Covidien (biotech ticker: COV)
FDA Decision Date: August 5 2009
Drug: Pennsaid (diclofenac sodium) topical solution
Updated: FDA extends NRIFF/COV new action date of Nov 4 2009.
NeurogesX Inc (biotech ticker: NGSX)
FDa Decision Date: August 16, 2009
Drug: Quentza for neuropathic pain
Auxilium Pharmaceuticals (biotech ticker: AUXL)
FDA Decision Date: August 28, 2009
Drug: Xiaflex for Dupuytren's contracture
Update: AUXL announced that FDA Arthritis Advisory Committee will reviewed Xiaflex on September 16 2009. FDA has not updated it new action date of August 28 2009.
I will update the next blog for this whole year soon, check back soon.
FDA Approval decision on a drug is a tremendous impact and huge significance for any biotech pharma, especially small cap biotech, for their years of research,labor and costs. Therefore, these FDA approval dates can be a make or break day for the company and demand great interest from investors for their company future valuation for the potential drug.
Nuvo Research Inc (biotech ticker: NRIFF)& Covidien (biotech ticker: COV)
FDA Decision Date: August 5 2009
Drug: Pennsaid (diclofenac sodium) topical solution
Updated: FDA extends NRIFF/COV new action date of Nov 4 2009.
NeurogesX Inc (biotech ticker: NGSX)
FDa Decision Date: August 16, 2009
Drug: Quentza for neuropathic pain
Auxilium Pharmaceuticals (biotech ticker: AUXL)
FDA Decision Date: August 28, 2009
Drug: Xiaflex for Dupuytren's contracture
Update: AUXL announced that FDA Arthritis Advisory Committee will reviewed Xiaflex on September 16 2009. FDA has not updated it new action date of August 28 2009.
I will update the next blog for this whole year soon, check back soon.
Welcome to BioTech Ticker, a biotechnology and investing blog
This is my first blog on BioTech Ticker, I've been wanting to write a blog specifically about stock market, biotechnology and investing for sometime now, make it 5 years, but haven't got around to get it done.
So, finally, here I am writing my first Biotechnology and Investing blog on Biotech Ticker. I created this blog for fun and hope that it maybe of some resources for what I called the "little guy", guys like myself, full-time career, trading on spare time, ticker watchers, like to take charge of his/her own financial freedom, risk takers with an ambitious goal in making money, who acknowledges that there are paramount risks and sometime all the odds are stacked against them, and still charge forward in the pursue of happiness.
My word of wisdom "It's a jungle out there, now go and play"
So, finally, here I am writing my first Biotechnology and Investing blog on Biotech Ticker. I created this blog for fun and hope that it maybe of some resources for what I called the "little guy", guys like myself, full-time career, trading on spare time, ticker watchers, like to take charge of his/her own financial freedom, risk takers with an ambitious goal in making money, who acknowledges that there are paramount risks and sometime all the odds are stacked against them, and still charge forward in the pursue of happiness.
My word of wisdom "It's a jungle out there, now go and play"
Subscribe to:
Comments (Atom)
Posts
