4:20 PM, Sep 30, 2009 --

• NYSE down 15.9 (0.23%) to 6,910.88.
• DJIA down 29.9 (0.3%) to 9,712.
• S&P 500 down 3.54 (0.3%) to 1,057.
• Nasdaq down 1.62 (0.1%) to 2,122.

GLOBAL SENTIMENT

From an anonymous poster regarding Discovery Labs (DSCO):

Hi VFC,

What about DSCO? Made a big move today - been around a long time.

In this post is a fresh list of 25 bullish stocks to watch for the week of September 14, 2009. I will be keeping my eye on all of these stocks this week, but chose only one to write a detailed option trade about this week. All of these stocks demonstrated tremendous strength during Friday's trade breaking out to the upside on huge volume. The table below shows the company, ticker, Friday's per share % increase, and Friday's volume increase (% increased compared to 50 day average). For your convenience I have ranked the stocks in order from greatest to least volume % change.

The stocks which are most attractive to me from the list above are: Informatica Corp, Innodata Isogen Inc, Fibertower Corp, and Select Comfort Corp. However from the four listed, the only stock which has options available to trade is Informatica, so below is a detailed option trade involving Informatica. To learn more about the option strategies outlined in this post, risks, pricing, calculations, other strategies, and options in general, click here.

4:10 PM, Sep 11, 2009 --

• NYSE down 6.98 (0.1%) to 6,843.83.
• DJIA down 22 (0.23%) to 9,605.
• S&P 500 down 1.41 (0.14%) to 1,043.
• Nasdaq down 3.12 (0.2%) to 2,081.

GLOBAL SENTIMENT

4:07 PM, Aug 14, 2009 --

• DJIA -76.7 or 0.8% to 9,321
• S&P 500 -8.6 or 0.9% to 1,004
• Nasdaq -23.8 or 1.2% to 1,986

GLOBAL SENTIMENT

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. I originally created this calendar to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Below are 12 extreme FDA trades for 11 companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included in extreme FDA and Clinical Trial Calendar trades, which are highlighted in periodic articles at BioMedReports.com.

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars.

. . . DSCO presents a model trade on a pending FDA decision at this time since it will likely enjoy a run-up in share price from current levels around $1.20 as the decision date nears. If DSCO experiences the bump in price, simply let the profits ride through the decision or just book all of the gains for a lower risk, lower reward trade on the expected increase in share price volatility heading into mid-April. . .

Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars.

Below are 12 companies with market caps below $200M which have pending new drug product decisions at the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced.

Disclosure: no positions

Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent.

Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved).

The wrinkle remover Medicis (MRX) is awaiting the approval of Reloxin, a type A botulinum vaccine. In 2006 the French drug company Ipsen granted Medicis rights to develop and commercialize its botulinum toxin product in the United States, Canada and Japan for aesthetic use. The development hit some wrinkles in 2007 when the FDA requested a re-filing of the BLA (Biologics License Application). The application was finally accepted in May 2008.

As a follow-up to my most recent article on the buyout binge among bio-pharma and diagnostic companies, below is a basket of 20 stocks (listed randomly) to consider for investing in 2009. The stocks are taken from the ETF Innovators Indexes of 250 companies which represent a mix of pending catalysts in the form of clinical trials or FDA decisions, innovative patent portfolios or drug discovery technology platforms, promising compounds in clinical development, and marketed therapeutic or diagnostic products. Click on any of the company names for links to all of my previous articles for those I have mentioned previously.

Emerging Diagnostic Index: Average loss of 63.2%, including 39 companies with average market cap of $50M

With news late Friday that Roche (RHHBY.PK) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic space.

Larger and well funded bio-pharma and diagnostic companies are opportunistically looking to expand their product offerings, pipeline prospects, patent portfolios, and drug discovery technology platforms with the huge declines in the stock prices for the 250 companies included in the following ETF Innovators Indexes:

Below are four companies I have not written about recently with expected catalysts in the first half of 2009 in the form of FDA decisions or clinical trial results.

Last fall, Discovery Labs (DSCO) received word from the FDA that its complete response for Surfaxin was accepted, but the six-month Class II review designation means that the decision date is pushed out to mid-April. DSCO presents a model trade on a pending FDA decision at this time since it will likely enjoy a run-up in share price from current levels around $1.20 as the decision date nears. If DSCO experiences the bump in price, simply let the profits ride through the decision or just book all of the gains for a lower risk, lower reward trade on the expected increase in share price volatility heading into mid-April.

Just before year-end, Electro-Optical Sciences (MELA) announced that the algorithms for analysis of the MelaFind pivotal trial were finalized with results expected to be released in several weeks. MelaFind involves a hand-held imaging device that emits light of multiple wavelengths to capture images of suspicious pigmented skin lesions and extract data for the early detection of melanoma, which is the most dangerous type of skin cancer.

Nanosphere (NSPH) recently filed 510(k) applications with the FDA for two new diagnostic products, including a cystic fibrosis assay and an infectious disease panel for respiratory viruses (influenza + respiratory syncytial virus or RSV). Since the 510(k) process is not as involved or length as a PMA; NSPH could receive word from the FDA by mid-2009.

The accompanying table of FDA decision dates (click to enlarge) is updated to include the following:

The accompanying table (click to enlarge) presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices.

Despite the notion of investing in the healthcare sector as a safe haven, the following six companies  Aspen BioPharma (APPY),  China Medical Technologies (CMED), Cypress BioScience (CYPB), Discovery Laboratories (DSCO),  Mylan Labs (MYL),  and Pfizer (PFE) are all down sharply over the past year, despite solid underlying fundamentals, which are largely unaffected by global economic conditions.

Diagnostics