Small Cap Biotech January/Febuary 2010 FDA Decision Dates

Below is a list of Small cap biotech January and February FDA decision dates – and the publicly traded companies that could see a price movement in their share prices as those dates approach, wheather is up or down all depending upon the decition. Good luck!

FDA decision due: Jan. 16, 2010
MannKind Corporation (NASDAQ:MNKD)
Regarding: Preliminary approval an inhaled insulation device called Afresa.
Share price as of 12/30/2009: $25.40

FDA decision due: Jan. 18, 2010
Roche Holding Ltd. (OTC:RHHBY)
Regarding: Approval for the use of Taceva for the treatment of lung cancer in patients already responding to chemotherapy.
Share price as of 12/30/2009: $42.18

FDA decision due: Jan. 22, 2010
Acorda Therapeutics (NASDAQ:ACOR)
Regarding: New drug application review for Fampridine-SR to be used to improve conduction in nerve fibers when the insulating layer (myelin) has been damaged.
Share price as of 12/30/2009: $25.39

FDA decision due: Jan. 30, 2010
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Regarding: The results of a meeting with the FDA to discuss the viability of continuing to seek approval for Fusilev for the treatment of colon cancer will be announced.
Share price as of 12/30/2009: $4.42

FDA decision due: Feb. 9, 2009
XenoPort, Inc. (NASDAQ:XNPT)
Regarding: FDA review results of gabapentin encarbil for the treatment of moderate-to-severe primary Restless Legs Syndrome.
Share price as of 12/30/2009: $18.48

FDA decision due: Feb. 11, 2009
Labopharm Inc. (NASDAQ:DDSS)
Regarding: Approval of Trazodone Contramid for depression.
Share price as of 12/30/2009: $2.03

FDA decision due: Feb. 12, 2009
Cadance Pharmaceuticals (NASDAQ:CADX)
Regarding: Approval of acetavance (intravenous acetamenophin) for the treatment of fever and pain.
Share price as of 12/30/2009: $9.73

FDA decision due: Feb. 13, 2009
Gilead Sciences (NASDAQ:GILD)
Regarding: Approval of Cayston for the treatment of cystic fibrosis.
Share price as of 12/30/2009: $43.93

FDA decision due: Feb. 28, 2009
Shire Pharmaceuticals (NASDAQ:SHPGY)
Regarding: Approval of velaglucerase to treat Gaucher’s disease (a genetic condition that causes fat buildups around internal organs).
Share price as of 12/30/2009: $58.20

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!