Disappointing Day For Alexza Pharmaceuticals

Image via CrunchBaseI quietly predicted today's FDA outcome on Alexza and Jazz Pharma's CRL, last week in my FDA Calendar prediction.  Here were My Predictions which stated that investor's should be shorting Alexza last week.  That would have netted a huge profit on Alexza's demise.  I think that shorting stocks or place put call options on FDA catalyst events can be profitable if done properly.  Although Jazz did not go down today, I do not see good things for their future

You really have to know what you are doing though when you make projections like this as is the drugs are approved then you will not be too happy with the results.  It's really a difficult line to cross but I see the value of Shorting Stocks under the Obama FDA panel.  The panel has rejected 4 drugs so far in October. 

That doesn't mean that you should have shorted Hospira or Human Genome Sciences (HGSI) because these are large and mid cap stocks that are affected less by these FDA decisions.  Human Genome has an upcoming drug approval in December for their Lupus therapy and I actually like the stock right now and consider it a buy.  Alexza and Jazz just had too many red flags for me for approvals.  You have to do your homework and look through the clinical trial data available.  Or just follow BioPharma Investor and let me give you helpful advice on these decision. 

Wikinvest--Alexza Pharmaceuticals (ALXA)  Closed:  1.35 Down 1.65 for a 54.46% Loss

Wikinvest--Jazz Pharmaceuticals (JAZZ)  Jazz will probably will be going down with today's CRL.

Jazz Pharmaceuticals Receives FDA Complete Response Letter Regarding JZP-6 for Treatment of Fibromyalgia


FDA O-Fer October Drug Approvals

BOSTON (TheStreet) -- U.S. regulators have to approve at least one new drug in October, right?


The U.S. Food and Drug Administration has a perfect 0-4 record so far this month -- four drug approval decisions, four drug rejections. Monday, Alexza Pharmaceuticals(ALXA) and Jazz Pharmaceuticals(JAZZ) received the bad news. Last week, it was FDA rejections for Human Genome Sciences(HGSI) and Hospira(HSP).

Perhaps the best shot for more positive news will come Tuesday when Alkermes(ALKS) is expecting FDA to rule on its drug for opioid addiction.

FDA Advisory Panels Recommends Fewer Drugs This Year

Image via Wikipedia It has been a rough year for Drug Candidates this year. Time after time FDA panels are rejecting more qualified drug approvals. So what really is going on here. Are drug up for FDA approval less safe, less effective, or are the panels more cautious on approvals. These panels have had a devastating effect on the company's stock after these No recommendations. Let's take a closer look into what's really going on.

FDA Advisory Panels: A Coin Flip

FDA staff: Jazz drug works, risk plan an issue

By Lisa Richwine

WASHINGTON | Wed Aug 18, 2010 11:23am EDT

(Reuters) - U.S. drug reviewers said a Jazz Pharmaceuticals Inc medicine helped patients with the pain disorder fibromyalgia, sending shares up 14 percent Wednesday on hopes an approval could sharply boost the company's sales.

Food and Drug Administration staff said the drug, sodium oxybate or JZP-6, was effective. But they also questioned if the company's proposed safeguards would adequately prevent improper use. The medicine contains an ingredient notoriously abused as a "date rape" drug.

Jazz Up Today Before Tomorrow's FDA Hearing, While Xoma Has Reverse Split

Image via Wikipedia By Val Brickates Kennedy, MarketWatch

BOSTON (MarketWatch) -- Shares of biotech group Xoma Ltd. spiked over 1,000% at market open Wednesday as the company conducted a 1-for-15 reverse stock split in order to boost its stock price to meet Nasdaq compliance rules.

For the next 20 trading sessions, Xoma will trade under the stock symbol XOMAD to reflect the split; after that time, the stock will revert back to its previous trading symbol of XOMA.

Xoma also announced that it has sold its royalty rights to the antibody treatment Cimzia for $4 million to an undisclosed buyer. The product, which is approved in the U.S. for the treatment of Crohn's disease and rheumatoid arthritis, is marketed by UCB S.A.


Shares of Xoma(XOMAD 3.68, -0.54, -12.82%), trading under its new symbol, were down 11% at $3.77.

Jazz Pharmaceuticals shares (JAZZ 11.37, +1.12, +10.93%) rallied after documents released by the U.S. Food and Drug Administration revealed that agency reviewers believe its drug candidate JZP-6 is effective in treating the pain condition fibromyalgia. The documents, however, also showed that they still have certain safety concerns about the medication.

Last Week's Top Performers for the BioPharma Market

I was almost too distaught to write an article after last Friday but decided we have to move on and look for gems in the rough. So there were a few Gems but a lot of Glooms. BioPharma Indexes are down almost 5 percent based on last weeks momentum downslide in the overall market. For just a taste of how bad it was ProShares UltraShort S&;P500 (ETF) (NYSE:SDS) was up 7.4% on shorting the market.

But lets take a look at some Top Performances last week.

Market Thoughts for Wednesday August 11th

The market took a hammering today but some stocks actually performed or are now great buys. The DOW Industrial average DIJA is closing sharply lower today at 10379. That's a 265 drop from yesterdays close of 10644 and a 2.49% decline as Global Fear strikes domestic and foreign markets.

Today's top performers in BioPharma for August 11th.

Biotech

Top BioPharma Pipeline Plays August 2010

Image via CrunchBase Stocks currently on my Watchlist for top BioPharma plays in the near future.

1. Valeant Pharmaceuticals (NYSE:VRX)

Biotechnology Research Report on Valeant's Potiga

On August 11, 2010, we expect the U.S. Food and Drug Administration's (FDA) Peripheral and Central Nervous System Drugs Advisory Committee to review the marketing application of Valeant Pharmaceuticals International’s (VRX) Potiga (formerly known as Retigabine), designed for the treatment of partial-onset seizures in epilepsy patients who have become refractory (failing to show response to prior therapy) to anti-epilepsy drugs (AEDs).

Trascept and Jazz Have Risen After Newsmakers in Biotech Industry Conference

Two stocks of note in the past week are Jazz Pharmaceuticals (JAZZ) and Transcept Pharmaceuticals .(TSPT). Last week Transcept attended the BioCentury Thomson Reuters Newsmakers in the Biotechnology Industry Conference on Sept 16, 2009. Jazz was also in attendance. It seems this conference is playing out as stocks have risen in the last week.

Transcept's stock has risen from a low of 11.00 before the conference to its current trading at 13.75. This is a fast rising company in its first year on Nasdaq. Jazz has jumped from a low of 9.16 to its current trading value of 9.72. Jazz has been up from earlier news that the CEO purchased 150,000 shares on Sept. 1-2, 2009 at 7.21 a share. Jazz Pharmaceuticals (JAZZ) Running On Buy From Smart Investor.

Jazz Pharmaceutical pays back loans and interest owed. Stock up big for today. JAZZ

Jazz Pharmaceuticals Pays Accrued Interest Under Senior Secured Notes

PALO ALTO, Calif., July 7, 2009 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals, Inc. (Nasdaq: JAZZ) today announced that it has paid to the holders of its senior secured notes the interest payments that were due, but not paid, on December 31, 2008, March 31, 2009 and June 30, 2009, for a total payment of approximately $14.6 million. The $119.5 million principal amount of the notes is due in June 2011. Jazz Pharmaceuticals also announced today that it has delivered to the holders of the notes financial statements for the quarter ended June 30, 2009, which indicate that Jazz Pharmaceuticals had achieved as of June 30, 2009 net product sales at the level required to suspend its prior obligation to maintain a minimum cash balance in an account that is pledged to the collateral agent for the notes. The requirement to maintain the account was triggered in May 2009, and Jazz Pharmaceuticals did not, at that time, establish the required account.


Jazz Pharmaceuticals believes that it has cured all material defaults under the agreement governing the notes, and that it will be able to comply with the agreement on an ongoing basis, including payment of future interest payments when due and repayment of the principal amount of the notes when due in June 2011.


About Jazz Pharmaceuticals, Inc.

Jazz Pharmaceuticals is a specialty pharmaceutical company that identifies, develops and commercializes innovative treatments for important, underserved markets in neurology and psychiatry. For further information, please see www.jazzpharmaceuticals.com.


The co also announced the signing and closing of a private placement of an aggregate of 1,895,734 units, comprised of an aggregate of 1,895,734 shares of common stock and warrants to purchase up to 947,867 additional shares of common stock for aggregate gross proceeds of approx $7 mln. The per unit purchase price for a share of common stock and a warrant to purchase 0.50 of a share of common stock was $3.6925. The warrants have an exercise price of $4.00 per share and are exercisable for seven years.

Jazz Quote FROM NASDAQ:
7/7/2009 12:56:39 PM Market Open
NASDAQ Last Sale
4.3001 0.67 18.46% UP
Volume
3,141,201
Previous Close
$ 3.63
Today's High
$ 4.98
Today's Low
$ 3.61
52 Wk High
$ 8.85 52 Wk Low
$ .515
NASDAQ Official Price
Open Price/Date
$ 3.86
Jul 07, 2009 Close Price/Date
$ 3.63
Jul 06, 2009
1y Target Est
$ 4.50