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.

The Street's FDA Drug Approval Contest: October's FDA Calendar

Image via CrunchBase Here is Ocotber's FDA Calendar. Along with the Calendar I have put my recommendation for each stock. Some you should really be buying, like Alkermes, others you should be shorting, like Arena, Vivus, and Jazz Pharma.

The poll has 3 results:
1. Full Approval
2. Complete Response Letter (aka delayed approval or no approval)
3. No Decision (more time, the FDA has a lot of approvals in such a given short period)

Oct. 1: Hospira's(HSP) Dyloject for acute moderate to severe pain in adults. (CRL)---Big Company so no big deal, still a buy

Oct. 4: Human Genome Sciences'(HGSI) Zalbin for hepatitis C. (CRL--Lupus drug approval set for December so still a buy)

Oct. 11: Alexza Pharmaceuticals'(ALXA) AZ-004 for agitation in patients with schizophrenia or bipolar disorder. (I'm going with No Decision, short this stock, as this is their first FDA decision for the Staccato technology) Slightly leaning toward CRL but I will say No Decision as my final answer.

Oct. 11: Jazz Pharmaceuticals'(JAZZ) JZP-6 for fibromyalgia. (CRL--FDA panel killed this drug, it works but the FDA isn't approving a GHB type drug right now. Short this stock)

Oct. 12: Alkermes'(ALKS) Vivitrol for opioid addiction. (Full Approval--Jim Cramer would say Buy, Buy Buy)

Oct. 16: ISTA Pharmaceutical (ISTA) XiDay is simply aonce daily version of twice daily solution, and avoid generic competition (FDA Approval)

Oct 22: Arena Pharmaceuticals'(ARNA) lorcaserin for obesity. (No way in he##, CRL) I would recommend shorting this stock.

Oct 22: Amylin Pharmaceuticals(AMLN) (Partnered with Alkermes and Eli Lilly) Once weekly Diabetes Shot exenatide or Bydureon---This is a delay from CRL in March so I expect Full Approval this time around.

Oct 28: Vivus'(VVUS) Qnexa for obesity. (Give me a break, CRL) I don't care what data they have come up with, I would recommend Shorting this stock.

Oct 29: Avanir Pharmaceuticals'(AVNR) Zenvia for pseudobulbar affect. (I'm going to go with Full Approval although it's a toss-up)

Forest Labs(FRX) ceftaroline for Community Acquired Pneumonia. I can't find this on the FDA calendar---But I will say Full Approval even though I can't find it.

Oct 30: Biodel's(BIOD) Linjeta for diabetes. (No Decision, short this stock) Again on the fence, possible CRL.

Jazz Pharma rejected for Fibramyalgia Drug by FDA vote 20-2

Image via Wikipedia Okay I'm not going to write an article about woulda coulda shoulda. But Jazz was shot down today heavily by the FDA by a vote of 20-No 2 Yes. Mostly due to concerns over abuse of the JZP-6 sodium oxybate drug which is highly similar to GHB. GHB was banned altogether by the FDA in 1990 and is viewed to have no medical benefits in the US.

Top Performing Biotech and Pharmaceuticals for Wednesday August 18th

Image via CrunchBase Today was a good day for recommendations and Friday gets even better with Jazz Pharmaceuticals presenting August 20th to the FDA for their Fibramyalgia medication JZP-6 sodium oxybate. Jazz had huge gains this morning as the FDA handed out their review of the clinical trial. Jazz shot up around the 11.90 mark and has been so oversold that right now it's pushing 10.49 in afterhours trading. It has been All Over The Map Today. Speaking of all over the map, BSD Medical exploded today with their medical device approval from the FDA. Just exploded all over the map. What a day.

Jazz was disappointing in the fact that everyone sold. Everyone is scared to death to leave it in the market for the FDA decision. Shoot the dice and let it roll sometimes. But we know where most people stand on this one. I'm taking my profits and waiting for tomorrow where I kick myself for selling. This one's a no-brainer in my department for Approval tomorrow.

Top Performing Biotech Stocks for Wednesday August 18th

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.

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).

Three Hot BioPharma Investment Plays: ARNA, JAZZ, and PRAN

 I have a few investment plays in the BioPharma field that I would like to share with everyone. These plays include Arena Pharmacueticals, Jazz Pharmaceuticals, and Prana Biotechnology. The first play is Arena Pharmaceuticals NASDAQ:ARNA. JP Morgan recently downgraded the stock Monday August 2 to Neutral, however Jim Cramer recommended the stock as a buy last Friday on his show MadMoney. Today's afterhours earnings estimate for Q2 was a better than expected loss and I see the stock rising heavily in the next month with the highly anticipated FDA panel review September 16th. ---I have since changed my outlook on all these stocks and actually recommend shorting them lately.

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.

Top Weekly Performers in Biopharma

Top Weekly Performers from:
Fri 04 Sep vs. Fri 28 Aug


Top 15 Gains (%) - ranked on change in share price



Rank/Company/Currency/Market Cap/Change in Market Cap/Notes

1 Nutra Pharma USD +89% 74M +34
Sep 2: Shares rise on 12.5x average daily trading volume.

2 Aerocrine SEK +65% 144M +57
Sep 3: Health Canada approves Aerocrine's Niox Mino, a medical device that measures inflammation in the airways, for use in treating asthma.

3 Peplin AUD +50% 129M +43
Sep 2: Leo Pharma announces agreed takeover of Peplin, for $288m.

4 Facet Biotech USD +48% 378M +123
Sep 4: Company receives a hostile takeover offer from Biogen Idec at $14.50 per share, having previously rejected a $15 per share offer; Biogen's offer values Facet at $355m, only around $45m higher than Facet's estimated cash of $310m; Facet's shares closed at $15.38 suggesting that the market expects Biogen will eventually have to raise its bid to close the deal.

5 The Medicines Company USD +46% 583M +184
Sep 2: Company announces that it has received a new patent from the US patent office for its anti-clotting drug, Angiomax, raising analyst hopes that onset of generic competition for the drug will be delayed.

6 Sinovac Biotech USD +45% 388M +120
Sep 3: The Chinese State Food and Drug Administration (SFDA) issues a production license for the company's H1N1 swine flu vaccine, Panflu, prompting the company to raise its revenue guidance for the year to greater than 20% growth. 31 Aug: Company receives a positive opinion for Panflu by an expert committee held by the Chinese SFDA.

7 Diamyd Medical SEK +36% 162M +42
Sep 3: Company reports 4-year follow-up data from a phase II trial of type 1 diabetes patients who received just two injections of Diamyd vaccine.

8 Jazz Pharmaceuticals USD +31% 287M +68
Sep 4: Shares rise on 5.5x average daily trading volume.

9 Transcept Pharmaceuticals USD +24% 164M +31

10 Algeta NOK +24% 337M +64
Sep 3: Company licenses global rights to its phase III, bone metastases cancer drug, Alpharadin, to Bayer for $61m upfront and potentially $800m in total, whilst retaining a 50% co-promotion and profit-share option in the US; Bayer will cover the majority of further developmental costs for Alpharadin.

11 AVI BioPharma USD +23% 191M +36
Shares of companies engaged in the development of a swine flu vaccine rise following a positive recommendation for Sinovac Biotech's swine flu vaccine in China on 31 Aug.

12 Protalix BioTherapeutics USD +23% 565M +107
Sep 3: Shares rise to a one-year high of $7.57 on increasing confidence in the company's Gaucher disease product, prGCD, and heightened speculation the company is a takeover target given its low cost plant cell-based biological manufacturing technology. 2 Sep: Hapoalim Securities initiates coverage with an "outperform" rating and price target of $10, claiming Teva could be a likely acquirer. 1 Sep: Shares rise on 5.5x average daily trading volume.

13 Sepracor USD +23% 2533M +470
Sep 2: Shares rise to a five-year high prior to a halt in trading on news that the company is to be acquired by Dainippon Sumitomo Pharma for $23 per share, or $2.7bn in total.

14 Cellectis EUR +21% 186M +33
Sep 1: Monsanto licenses the use of Cellectis' genome modification technology for the development of meganuclease technology in plants; company to receive €3m upfront, milestones and royalties.

15 Curis USD +21% 159M +27
Sept 2[post-market]: The New England Journal of Medicine publishes two encouraging papers on GDC-0449, a drug which targets the hedgehog pathway, including phase I data from a trial in the rare skin cancer basal cell carcinoma; Curis and partner Roche have a phase II trial in the indication ongoing; the papers raise hopes that the drug will prove successful in fighting skin cancer and possibly other tumour types.

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