Biotech/Pharma Stocks and Upcoming FDA Actions Dates

A few biotech stocks whose FDA approval/response dates are coming up are listed here without any analysis or predictions. Momentum traders could use these tickers, study the stock behavior and make appropriate trades. Or look at the drug/device's long term trial/data process and make bets on either side of the trade and hold steady. Good luck and don't be greedy. Stocks are listed from the nearest date of decision onward. Thanks for a diligent poster (sxyam) on the yahoo message board of HUN.
Chelsea Therapeutics(CHTP Quote)
Drug/indication: Droxidopa for neurogenic orthostatic hypotension
Outcome of FDA meeting to discuss changing primary endpoint of phase III study: December 2009.

Cephalon(CEPH Quote)
Drug/indication: Nuvigil for jet lag disorder
FDA approval decision date: Dec. 29

Arena Pharmaceuticals(ARNA Quote)
Drug/indication: lorcaserin for obesity
Filing for FDA approval: December 2009

Auxilium Pharmaceuticals(AUXL Quote)
Drug/indication: Xiaflex for Dupuytren's contracture
FDA approval decision date: December 2009

Biodel(BIOD Quote)
Drug/indication: Viaject for diabetes
Filing for FDA approval: December 2009

Novartis(NVS Quote)
Drug/indication: fingolomid for multiple sclerosis
Filing for FDA approval: December 2009

Novo Nordisk(NVO Quote)
Drug/indication: Victoza for diabetes
FDA approval decision date: December 2009

Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: Replagal for Fabry's disease
Filing for FDA approval: December 2009

Vivus(VVUS Quote)
Drug/indication: Qnexa for obesity
Filing for FDA approval: December 2009

Mannkind(MNKD Quote)
Drug/indication: Afresa for diabetes
FDA approval decision date: Jan. 16, 2010

Acorda Therapeutics(ACOR Quote)
Drug/indication: Amaya for multiple sclerosis
FDA approval decision date: Jan. 22, 2010

Spectrum Pharmaceuticals(SPPI Quote)
Drug/indication: Fusilev for colon cancer
Outcome of meeting with FDA to discuss complete response letter: January 2010

Labopharm(DDSS Quote)
Drug/indication: Trazodone Contramid for depression
FDA approval decision date: Feb. 11, 2010

Cadence Pharmaceuticals(CADX Quote)
Drug/indication: acetavance for pain
FDA approval decision date: Feb. 12, 2010

Gilead Sciences(GILD Quote)
Drug/indication: Cayston for cystic fibrosis
FDA approval decision date: Feb. 13, 2010

Salix Pharmaceuticals(SLXP Quote)
Drug/indication: Xifaxan for hepatic encephalopathy
FDA advisory committee meeting: February 2010
FDA approval decision date: March 24, 2010

Shire Pharmaceuticals(SHPGY Quote)
Drug/indication: velaglucerase for Gaucher's disease
FDA approval decision date: Feb. 28, 2010

Amylin Pharmaceuticals(AMLN Quote)
Drug/indication: Exenatide LAR for diabetes
FDA approval decision date: March 5, 2010

Clinical Data(CLDA Quote)
Drug/indication: vilazodone for depression
Filing for FDA approval: First quarter 2010

Somaxon Pharmaceuticals(SOMX Quote)
Drug/indication: Silenor for insomnia
Outcome of FDA meeting to discuss complete response letter: First quarter 2010

Cell Therapeutics(CTIC Quote)
Drug/indication: pixantrone for non-Hodgkin's lymphoma
FDA approval decision date: April 23, 2010

Eli Lilly(LLY Quote)
Drug/indication: Erbitux for first-line non-small cell lung cancer
Filing for FDA approval: First quarter 2010

Dendreon(DNDN Quote)
Drug/indication: Provenge for prostate cancer
FDA approval decision date: May 1, 2010

Avanir Pharmaceuticals(AVNR Quote)
Drug/indication: Zenvia for pseudobulbar effect
Filing for FDA approval: Second quarter 2010

Alkermes(ALKS Quote)
Drug/indication: Vivitrol for opioid addiction
Filing for FDA approval: First half 2010

InterMune(ITMN Quote)
Drug/indication: pirfenidone for idiopathic pulmonary fibrosis
FDA advisory committee meeting: First half 2010

FDA approval decision date: Second half 2010

Human Genome Sciences(HGSI Quote)
Drug/indication: Benlysta for lupus
Filing for FDA approval: First half 2010

Orexigen Therapeutics(OREX Quote)
Drug/indication: Contrave for obesity
Filing for FDA approval: First half 2010

CDC Update

The Center for Disease Control (CDC) analyzes influenza activity and publishes key findings each week.

Key Flu Indicators

FluView.*

During the week of November 1-7, 2009, a review of key indicators found that certain indicators declined, while others continued to rise. Overall, flu activity in the United Sates remained very high. Below is a summary of the most recent key indicators:

• Visits to doctors for influenza-like illness (ILI) nationally decreased this week over last week. This is the 2nd week of national decreases in ILI after four consecutive weeks of sharp increases. (Visits to doctors for ILI is still higher than what is seen during the peak of many regular flu seasons.
• Total influenza hospitalization rates for laboratory-confirmed flu continue to climb and remain higher than expected for this time of year.
  
• The proportion of deaths attributed to pneumonia and influenza (P&I) based on the 122 Cities Report continues to increase and has been higher than what is expected for six weeks now.
• Forty-six states are reporting widespread influenza activity at this time; This many reports of widespread activity at this time of year are unprecedented during seasonal flu.
• Almost all of the influenza viruses identified so far continue to be 2009 H1N1 influenza A viruses. These viruses remain similar to the virus chosen for the 2009 H1N1 vaccine, and remain susceptible to the antiviral drugs oseltamivir and zanamivir with rare exception.

Our inferences and predictions:
The rare exception as well as the cases of hospitalization both seem to be good candidates for increased use of peramivir (BCRX) or intravenous Relenza (GSK)/Tamiflu (RHHBY.PK).

NVAX Special Opinion

If any new investors to NVAX are panicking because of this article on Motley Fool, fear not. The Fool used to be a good source, but with their open source approach of letting anyone write articles, it has become a general bulletin board where everyone is free to dish their opinion. For instance, the author Tim Hanson has completely missed Novavax's long standing work in virus like particle (VLP) technology based vaccines for seasonal flu.
In fact NVAX is currently initiating phase II studies on comparing the dosing of its VLP based vaccine to existing flu vaccines (of other companies) {press release pdf}.

The problem with this approach is that there is no objective or comprehensive coverage of companies. Instead, we have a piecemeal approach picking on factors and comments on "absence of long term plans" -(paraphrased).

Tim Hanson says:
"I'm not here to be negative about either Novavax"

That was a funny circuitious route towards attacking a company which has very clear long term plans. Especially with long term manufacturing agreements with Cadila (india) and another company in Spain. They also have seasonal flu vaccines for long term (let me see) EVERY YEAR. Stop whining about sour grapes and actually make some real research. In addition, NVAX CEO has come to Novavax with 25 yrs big pharma experience because he saw big potential here.

Anyways, i am sitting in NVAX, long term with several long calls for next year. I am not concerned much. But what I am concerned is for small retail investors (who I was one of 3 years back) who would be misled by these opinions posing as research.

With today's search capabilities, it is quite easy to come up with a timeline of almost anything. In case of NVAX, you can check out their timeline with vaccine development and other progress here.

SVA NVAX BCRX APT

Expect moves in Sinovac (SVA), Novavax (NVAX), Biocryst (BCRX) and Alpha Protech (APT) this week and in early November. I expect most of these moves to be on the upside.

Biocryst Pharma recently received Emergency Use Authorization for Permamivir (it's IV administered antiviral for use in hospitals against H1N1 flu disease). Sinovac accounced additional orders on Tuesday morning. Novavax and Alpha Protech are solid bets, APT has true revenues from products and Novavax is producing vaccines for trials in Mexico, has joint agreements in India and other good prospects.

• Sinovac Biotech Ltd. (courtesyYahoo finance)
  

BEIJING, Oct. 27 /PRNewswire-Asia/ -- Sinovac Biotech Ltd. (NYSE: SVA - News), a leading provider of biopharmaceutical products in China, announced today that it has received its third purchase order for its H1N1 vaccine, PANFLU.1, from China's Ministry of Industry and Information Technology for the national stockpiling plan. Under this purchase order, Sinovac is required to produce an additional 5.19 million doses of PANFLU.1 (15ug/0.5ml) for the Chinese central government. Out of today's announced PANFLU.1 order, Sinovac is required to complete delivery of 2.89 million doses to the appointed provincial and municipal governments by the end of this year and supply the remaining 2.3 million doses for the central government stockpiling.

Symbol	Price	Change
SVA	8.06	0.00

The latest 5.19 million dose purchase order is in addition to an initial order for 3.3 million doses and second order for 3 million doses received by Sinovac from the Ministry of Industry and Information Technology of China on September 4, 2009 and September 30, 2009, respectively, for a total of 11.49 million doses.

Novavax, Biocryst to make big moves

Novavax and Avimex are initiating the blinded, placebo-controlled clinical trial in Mexico City to evaluate the safety, immunogenicity and efficacy of Novavax's 2009 H1N1 VLP vaccine in healthy adults. Biocryst Pharma is showing lot of promise with its antiviral drug Peramivir. (after the jump)

The first stage will evaluate the vaccine's safety, immunogenicity and efficacy among 1,000 subjects, including 750 VLP recipients and 250 placebo recipients. Pending favorable results from the first stage, the second stage of the study will be initiated to evaluate the safety of the vaccine in a larger cohort of 3,000 subjects (2,000 vaccine and 1,000 placebo recipients). The primary safety and immunogenicity results are expected within 3 months of the start of this study in January 2010. If the results are clinically acceptable, they will be used to seek registration of Novavax's 2009 H1N1 pandemic flu vaccine in Mexico. These data are also expected to support development of the company's pandemic and seasonal flu VLP vaccines in other countries, including the United States.
http://www.marketwatch.com/story/novavax-ge-avimex-set-mexico-h1n1-vaccine-trial-2009-10-20?siteid=yhoof2


Watch this video to find out more:
http://www.wral.com/business/story/6241972/DIRECT LINK TO VIDEO

Insurance Securitization and how it might affect cures to any fatal diseases

This post is big time speculation/prediction without any facts to back it up, really. This is, at this point of time, a flight of imagination on how conflicts of interest can develop for investors who invest in life insurance settlement policies etc.

Refer to this article on NY Times and then read comments (italics) below in context:


"Enter life settlement companies. Depending on various factors, they will pay 20 to 200 percent more than the surrender value an insurer would pay."
but this will obviously be much less than the policy benefit value. but the reporter does not even mention that.

Another quote: "That is because if too many people with leukemia are in the securitization portfolio, and a cure is developed, the value of the bond would plummet."
Using my complex math models, I can predict that investors in this class of assets will be against healthcare advances curing diseases like leukameia, cancer, etc - ie many fatal diseases. I think I will now repeat my comment: Welcome to a new class of private death panels, it used to be just insurers, but now wall st investors also join that group.

Performance Report

(click image to see full size) or link below to see chart on yahoo finance.

PERFORMANCE CHART OF SOME OF MY MAJOR PREDICTIONS FROM MAY 31 to AUG 31.

Except for HEB almost all other small caps have had more than 100% returns (also except of BMY of course)


http://finance.yahoo.com/echarts?s=HEB#chart2:symbol=heb;range=3m;compare=nvax+apt+medx+bcrx+ino+apwr+bmy;indicator=split+ke_it+volume+mfi+rsi;charttype=line;crosshair=on;ohlcvalues=0;logscale=on;source=undefined


Loss making stocks/bad trades: MENT (got out at wrong time, 3% loss), INO never got in, MEDX - got out too soon.

place only Limit price orders

Here is a good article on why even limit pricing orders does nt guarantee you to fair access to sellers's prices. But at least you will not be screwed over like in a 'market" order.
High Frequency Trading, Impact on 'slow traders'.

BMYcovered

BMY (bristol myers squibb) Covered calls strategy example.
If by some stroke of good luck you had bought BMY when it was trading at 19.21 (hypothetical example), i will explain here how you can make some money on regular basis by selling covered calls for higher strike price alongwith your usual dividend income also. (See wiki link at bottom for basic definition etc.)

All numbers hypothetical
BMY basis price: 19.20
No of shares = 800

Suppose you write covered calls for the $20 strike price (I usually recommend writing calls on a bullish day, early on in the options cycle, ie the first week after OPEX)

When you write a call at $20 you are guaranteeing delivery of the stock at a price of $20 at OPEX or anytime in between if called. In return you get the premium.

If you write 4 covered call contractss = you guarantee delivery of 400 shares (1 contract = 100 shares) at $20. The premium which you get (depending on the day etc.) would be the option price x 100 minus commissions.
The July BMY $20 call BMYGD.X has traded between 0.20 to 1.27. let us say you wrote the call on a day when the price was at 0.65. Then you get 0.65 X 100 X 4 =$260 (minus commission of 28+3) for the calls you write. YOU GET THIS MONEY into your account as cash.

Now if the stock stays at $20.01 or above on the third Friday of the month of July, your 400 BMY shares will be called out at the prevailing price, let us assume it is 20.01, and your 400 shares will be sold at 20.00 (a profit of 0.81 cents/share) minus sell commissions. If the prevailing price were 20.20 then they will still be sold at 20.00 so you "lose" as theoretical profit of 0.20 addl cents. If the stock had gone up to $25 (due to any reason), then you lose the $5.80 profit potential. So covered call is not a great strategy with super volatile stocks, imo.

But remember, you had already enjoyed a rental money of $260 on your 400 shares from the day you sell the calls. however you can still get that gain on your other 400 shares.

if the stock stays below 20, you dont do a thing you keep your stock and your 260 dollars.

RISKS: The risk is that if there is a catastrophic fall in price intra day anytime during the month, you cannot sell the shares UNTIl you close out your covered call by buying back calls (which will be at a lower price).

Anyways you can TEST strategies like these at OPTIONXPRESS using their VIRTUAL TRADING tool. You do need to create an account (no money needed, but only deal with occasional emails), and then you can practice this stuff.
UPDATE: Another free options but slightly complicated options simulator can be found here (courtesy RIGL board)

If you write calls on all 800 you make more rent plus you "lose" less on commissions. Option contract commissions vary, it is $7+ 0.75/contract with Scottrade. It is 4.50 + 0.50 /contract with ZECCO. Optionxpress has its commissions at 14.95 or 19.95. Others vary, but option commissions are kinda pricey.

Other References:
Wiki entry
Options Education
Daily Quotes of option prices (BMY)

HemispherX Annual Shareholder Meeting Update

HEB held its shareholder meeting yesterday in Philadelphia PA, USA. I didn't attend the meeting but followed it via a message board updates and then reviewed the press release today. Two things caught my eye there in the SEC filing...

One was this: As with last year's Annual Meeting of Stockholders, there was an extremely low turnout. The Company believes that this was due to the fact that more than 40% of its outstanding shares are held outside the United States

The other: The Company left the polls opened with regard to voting on the amendment of its certificate of incorporation to increase the number of authorized shares of Common Stock from 200,000,000 to 350,000,000 and adjourned the meeting solely with regard to this proposal until July 28, 2009 at 1:00 p.m. at the Embassy Suites Hotel, 1776 Benjamin Franklin Parkway, Philadelphia Pennsylvania 19103. The Company did this due to the extremely low vote turn out and the requirement that this proposal be approved by the holders of a majority of the outstanding shares, rather than just a majority of the shares present at the meeting. In fact, less than the requisite number of shares for approval of the proposal were present at the meeting. Obviously this is a good requirement and thankfully the BOD cannot wing through this without a full vote by majority shareholders. [SEC Filing] (smaller Press release).
Actually one other thing was this:

Adoption of our 2009 Equity Incentive Plan:

For: 10,688,703            Against: 3,166,098        Abstain: 569,495.
Fairly large no of people against and rightfully so in my personal opinion.
Shareholder rewards are not much yet so management/director rewards seem a
little high.

Anyhow, get ready for some wild action today and tomorrow. Or better yet, do not follow the ticker. Just hold - well that is my opinion anyway.

Microcap Biotech Companies: Are they hiring?

Depending on what kind of hiring some biotech companies are into, we can glean some insight into their future operations. Based on this we can "guess" stock moves slightly better than throwing darts while blindfolded, right? Maybe. This is still a risky method, requires patience [1: see HEB] and you may hit a home run only occasionally [2: see NVAX]. We will cover these companies today:
ABIO, GNBT, KOOL, NVAX (2nd time), PPHM, TTNP.PK, VPHM
First, let me point out that none of these are recommendations at this stage. I am holding HEB NVAX GNBT PPHM and KOOL, but I have also been trading in and out of these while holding a small core position. I do this because I have very low commissions with Zecco, and some free trades with Sogotrade (plug) and Scottrade. Anyhow moving to the topic at hand, let's first review ABIO:

Air Products - Long Term Play

Air Products (APD) 

Copied post from Updown.com Analysis:

Posted 912 days ago on 10/05/08

Market call:APD will go UP
Target: $85.00 on 10/05/09
Current: $92.30 (45.65% from time of market call)

I am reopening an older analysis because the broad market weakness and fall in oil prices have smashed this company's stock price. Air Products and Chemicals is a specialty gases company (primarily) but it also has large stakes in emerging industries that use carbon fibers, nanotechnology and hydrogen fuel applications. This company has paid out dividends regularly for about 25 years with modest increases in the dividend payout over time. Some of the negative factors against the company are reduced spending by other businesses (which draws down APD's earnings) and the strengthening dollar. Also if you look at the sector, APD's main competitor, Praxair (PX) has also been performing barely ok,in fact it is lagging the indices. However, at these valuations (~$64-66 range) the stock looks beaten down so I am not afraid to pick up some for long term or for short term trading. As always do your own additional due diligence. I intend to open a long postion this week in the 63-66 range if the broad market does not tank,