Update: Small Cap Biotech Important FDA/ Action Dates for October

Here are the biotech ticker action dates for October, enjoy and now go play!

Oct. 8th

The FDA accepted Spectrum Pharma’s (biotech ticker: SPPI)supplemental New Drug Application (sNDA) for FUSILEV (levoleucovorin) for injection on 3/26/09 in combination with 5-FU containing regimens in advanced metastatic colorectal cancer. The user fee goal (PDUFA) date for the sNDA is October 8 2009.

Oct. 13
Presentation at the American Neurological Association meeting of detailed data from the phase III study of Avanir Pharmaceuticals’ (biotech ticker: AVNR) Zenvia, an experimental drug for the treatment of uncontrollable laughing and crying episodes — a condition known medically as pseudobulbar affect.

Oct. 14
The FDA’s Peripheral and Central Nervous System Drug Advisory Committee will convene to review Acorda Therapeutics’ (biotech ticker: ACOR) fampridine (brand name Amaya). The proposed indication for Amaya is to improve the walking ability of patients with multiple sclerosis.

Oct 22

Acorda Therapeutics, Inc. (ACOR). The U.S. Food and Drug Administration (FDA) is currently reviewing a New Drug Application (NDA) for Fampridine-SR. The NDA was assigned Priority Review and a Prescription Drug User Fee Act (PDUFA) date of October 22, 2009.

Oct. 24-28
The Obesity Society annual meeting convenes in Washington, D.C. Detailed data from phase III studies of three closely watched weight-loss drugs will be presented at the meeting: Arena Pharmaceuticals’ (biotech ticker: ARNA) lorcaserin, Vivus (biotech ticker: VVUS) Qnexa and Orexigen Therapeutics’ (biotech ticker: OREX) Contrave

Oct. 30
FDA approval decision date for GTXI Inc. (biotech ticker: GTXI) Acapodene for the reduction of bone fractures in prostate cancer patients undergoing androgen deprivation therapy.
FDA approval decision date for Transcept Pharmaceuticals’ (biotech ticker: TSPT) Intermezzo for insomnia.

Tagged with: Biotech Ticker Clinical Trials, FDA Approval, GTXI, TSPT, ARNA, VVUS, SPPI, AVNR, ACOR, OREX,

FDA approved: Allos Therapeutics' Great News

Great news for Allos Therapeutics (biotech ticker: ALTH) with FDA approval, congrats to the long (decade long) and hard work they have put into this anticancer lymphoma, the novel drug (one only for T-cell lymphoma refractory treatment) So this is a paramount turning point for the company right ? With production and marketing already in place, and the technology to further advance in t-cell targeted specific drug? With price target conservatively at 12-15 pps by most analysts?
Well, despite the FDA approval of ALTH; all the great news and long term prospects (makes that end of this month with launching of Fotolyn) the short term play by individuals manipulation of the stock are at it again. Selling off and price manipulation or quite possibly the feared of company future public stock offering to raise capital and dilute existing shares. (i.e. SPPI) But who knows, these are all speculative and manipulation. One huge speculative put to rest is that the drug is approved will treat and cured cancer, save lives and will make money period. So best hedge to play this stock is load up more on the dip (now or if public stock offering) and hold at least til end of this October. I suspect IF no announcement of stock offering but announcement of partnership (or better yet M&A is not unlikely) in the near future. So hang tight! it's a jungle out there, now go and play or sit on the bench and watch.:)

disclosure: long on ALTH, DNDN, eyes out: GTXI, SLXP



tag: ALTH, DNDN, GTXI,SLXP

Will this time; Arena Pharmceuticals Phase III Proved Positive?

Arena Pharmaceuticals announced today (9/17/2009) that they will release their second trial data from the BLOSSOM study (Arena Pharma Phase III results) of their anti-obesity drug, Locaserin on Friday. Will the results of the ARNA Phase III be a positive and stay in the race with their top competitors; OREX and VVUS or will it be an inconclusive results and receive similar fate as their first data result back in 3/30/09? There have been huge anticipation for ARNA Phase III results since their lack luster prelim phase III, since then their share have soar 10%. Currently, there are two views of speculators in play on ARN BLOSSOM results; some analysts speculate that the results will be significance and with buy rating at $11 and anticipate ARNA high safety number and will receive FDA approval. In the other view, Rodman & Renshaw downgraded Arena to market perform from market outperform, with no price target. With analysts speculate ARNA's Locasarin if approved still not be doctor's first choice in treatment and rather prefer VVUS's Qnexa or Orexigen's Contrave as monotherapy drug.

All speculations will soon put to rest, and the best part, we don't have to wait for days, just 24 hrs. Arena pharma price soar 35% with 3.3millions in volume after market trading in anticipation of the news. Will the news be repeated like the last time or will the news set a standard for the new anti-obesity treatment therapy? Only time will tell.



tag: ARNA, VVUS, OREX

Dendreon: The Next Great Small Biotech Co.

Could Dendreon (biotech ticker: DNDN) be the next great small cap biotech in the pharma world of maga pharmaceuticals? There is a good article series by Mark Mitchell on Dendreon, a small cap Seattle based biotech, that has a flagship drug called Provenge, which is a novel prostate cancer treatment , but has revolutionary treatment approach, has to traverse paramount obstacles with the great hope in saving lives.

Dendreon recent run up of about 10% (closed at $26.4)in past two days with volume of approximately 21 millions on apparently no news. Could this surge be due to market adjustment of the stock or on anticipated news ? Well just have to wait and see. However, many speculates that Dendreon recent surged came from rumor of a buyout talk in Europe. Whichever may this be, I believe that Dendreon and it history has established itself to be huge force in the biotech market once their flagship drug Provenge get the approved from the FDA.


tag: DNDN,Provenge,Dendreon

The Race is Heating Up for Anti-Obesity Drug Makers

Lipitor, Zocor, Nexium, Prevacid, Advair, Plavix, Zoloft, and Epogen just to name a few. So what do these drugs have in common? Yes, these are not only the most recognizable drugs due to their huge marketing effect, but these are also a multi-billion dollar drugs. So what do these drugs have to do with obesity? Well, nothing, but the fact that obesity is the most prevalence, 65% of American adult are obese, and American spent $123 billion a year in medical and related cost, therefore the potential market for obesity is a multi-billion dollar one. And the race to be the first to market the next anti-obesity and assume a leading position in the multi-billion dollar market is beginning to heat up. So who are the key players in this race?

- Orexigen Therapeutics, Inc.(biotech ticker: Orex) Drug: Contrave
Company announced that their anti-obesity,Contrave, met phase III end point for their obesity drug on July 20th and since the announcement shares are up 60% and will file with the FDA by 1Q 2010.

- Vivus Inc (biotech ticker: VVUS) recently announced a positive phase III results of their flagship antiobesity drug,Qnexa, and since the announcement on Sept 8th 2009 the stock price up almost 75%. Company announced they will file with FDA by year end.

- Arena Pharm (biotech ticker: ARNA) plan to announce their phase III drug, Lorcaserin, and soon after will file for FDA to market their anti-obesity drug by year end.

There you have it, the top leading small cap biotech anti-obesity drug makers. The race to be the first to market the drug, sign big partnership and capture the huge market potential has begun. So the question, Who will win the FDA approval and get a crack at the huge market potential? We will have to wait and see, and definitely worth keep an eye out.



tag: ARNA,VVUS,OREX

SPPI got positive news from FDA but turned negative on the market

This past Friday(8/4/09) the FDA gave Spectrum Pharma(biotech ticker:SPPI) the much anticipated news, in fact it came 3 days before the actual action date, that they approved SPPI’s drug Zevalin for first line use of non-Hodgkin’s lymphoma. The approval of zevalin will enable SPPI to expand the drug beyond their current use and open up to new market potential and hence increasing their company valuation. And one would think that the market will put this new valuation of the company in place and lift their pps higher. Well, to everyone surprised the market did just that, but only for a few minutes, and turned negative and closed near 5% down. So what happened? Why negative on positive news? Is this the case of buy the rumor and sell the news? The market so keen on the valuation and figured that SPII is already priced in or is the something else entirely?

Well, to answer these questions let just take a closer look.
1. There is huge anticipation and speculation of SPII’s FDA action date.
The lesson here is the speculators driving the herds.

2. Why negative and not stayed same?
The lesson here is buying on rumor and sells on news.
Once the price reached it resistance point, speculators a sell off trend, in SPPI case $ 10, so this is the case of a mad sell off to make quick money on the news, and once it started the effect, it also takes out limit, stop loss and combining it with short position into play created the snow ball effect.
However, the snow ball effect didn’t turn into an avalanche effect and only minimized to 5% loss. In my opinion, it is because the news were released 3 days early as suppose to wait until Tuesday where the price could go well over the $10 range and the manipulators/speculators play will inevitably played out and the loss could be in the 25% with huge swing, so I believe the company knew this and to overall protect the interest of the company investors the company released the news early.

3. Is the current price reflected the current valuation for SPPI pps?
The lesson here, don’t buy on hype but buy on a sell off.
The market overall is not a very good at valuating the company in general especially small cap biotech company, and this is where it is most exploited and manipulated. There is no magical formula in the valuation of speculative play in SPPI, no trends (in spite of most claims), statistical indications, or simple rule of thumbs, but it is based purely on speculations of their future valuation. However, one speculation did put to rest, in that SPII got approved on Zevalin and two more to go, with one valuation already played and a massive selloff and price resistance at 7.90-8.10 one can fairly feel confident that this is the new low for SPPI in their upcoming speculative plays.
There you have, now go and play!

Dark Tuesday for the market, even darker for a few small cap biotech stocks

Acadia Pharma (biotech ticker: ACAD) shares tumbled nearly 70% (closed at 2.00) after company announced that their flagship, Parkinson’s drug, pimavanserin did not meet end point in their phase III testing.

Vion Pharma (biotech ticker: VION) shares dropped 23% (closed at 2.60) after FDA's cancer drug advisory panel voted unanimously against approval of Vion's leukemia drug Onrigin.

Sequenom, Inc (biotech ticker: SQNM) shares moved 14% (closed at 5.50) lower after sources confirmed that the rumor on news about strong indications for Sequenom's genetic prenatal test for Down syndrome results were fabricated and false, no news were released.


Tuesday update from top 5 Monday biotech gainers
HLCS gave back 14.5% closed at 2.39
ENCO gave back 10% closed at 0.225
BNV gave back (5.31%) closed at 0.606
CRIS gave back (0.5%) closed at 2.10
ULU unchanged closed at 0.18

Top 5 Gainers: Biotech Penny Stocks on the Move

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

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.

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.

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.

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.

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).

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

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.

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.

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.

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.

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"