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  • ALXA - Potential For A Run-Up (FDA Catalyst on 10/11/10) 1 comment
    May 17, 2010 2:13 PM | about stocks: ALXA

    Another promising run-up play for October is Alexa Pharmaceuticals and its lead candidate AZ-004, which is an inhalation product candidate for the rapid treatment of agitation in patients with schizophrenia or bi-polar disorder.  It has a PDUFA date of October 11th, 2010.

    Let’s take a look at the chart for ALXA over the past few months:

     

    It is clear to see that a nice run-up is developing.  Let’s take a look at Alexza and it’s pipeline of products.

    About Alexza

    Alexza Pharmaceuticals is a pharmaceutical company focused on the research, development and commercialization of novel, proprietary products for the acute treatment of central nervous system conditions. Alexza’s technology, the Staccato(NYSE:R) system, vaporizes unformulated drug to form a condensation aerosol that, when inhaled, allows for rapid systemic drug delivery through deep lung inhalation. The drug is quickly absorbed through the lungs into the bloodstream, providing speed of therapeutic onset that is comparable to intravenous administration, but with greater ease, patient comfort and convenience.

    AZ-004 (Staccato loxapine) is Alexza’s lead program, which is being developed for the rapid treatment of agitation in schizophrenic or bipolar disorder patients. Alexza has completed and announced positive results from both of its AZ-004 Phase 3 clinical trials, submitted a New Drug Application submission in December 2009, and has a Prescription Drug User Fee Act (PDUFA) goal date of October 11, 2010. In February 2010, Alexza established a partnership with Biovail Laboratories International SRL, a subsidiary of Biovail Corporation, to develop and commercialize AZ-004 in the U.S. and Canada.

    Alexza has completed an end-of-Phase 2 meeting with the FDA for AZ-001 (Staccatoprochlorperazine) and has completed two Phase 2 studies with AZ-104 (Staccatoloxapine, low-dose). Both product candidates are being developed for the acute treatment of migraine headache.

    AZ-002 (Staccato alprazolam) has completed Phase 1 testing and one Phase 2a proof-of-concept clinical trial. Product candidates that have completed Phase 1 testing are AZ-003 (Staccato fentanyl) for the treatment of breakthrough pain, and AZ-007 (Staccatozaleplon) for the treatment of insomnia. More information, including this and past press releases from Alexza, is available online at alexza.com.

    Financials

    From Alexza’s most recent 10-Q filing with the SEC (5/10/10)

    As of March 31, 2010, we had $41.0 million in cash, cash equivalents and marketable securities. In May 2010, we borrowed an additional $15 million. Our cash and marketable securities balances are held in a variety of interest bearing instruments, including obligations of U.S. government agencies, high credit rating corporate borrowers and money market accounts. Cash in excess of immediate requirements is invested with regard to liquidity and capital preservation….

    We believe that with current cash, cash equivalents and marketable securities along with interest earned thereon, borrowings under the Hercules loan agreement, the proceeds from option exercises and purchases of common stock pursuant to our Employee Stock Purchase Plan, we will be able to maintain our currently planned operations through the second quarter of 2011 and will extend into 2012 if we achieve the eligible milestones under the Biovail collaboration during the next 12 months. Changing circumstances may cause us to consume capital significantly faster or slower than we currently anticipate. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available financial resources sooner than we currently expect.

    Trading Method

    ALXA seems to be another perfect candidate for the run-up method.  I already have a small position, however I look to increase my holdings as we get closer to July-August.  My target run-up price for ALXA is $8 per share.  Before a series of dilutions ALXA was trading at nearly $13 a share when it announced its positive results from the Phase 2b study of AZ-004.   My advice on this one is to get in early and hold until a few weeks out from the FDA date.

    Enjoy.

    Disclosure

    Long ALXA
     

    See my website at www.BioRunUp.com for more trading information and daily updates to the free, no registration, FDA calendar.  Make sure to sign up for the spam-free email updates through Google's FeedBurner. 



    Disclosure: long ALXA
    Stocks: ALXA
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  • jakebet
    , contributor
    Comment (1) | Send Message
     
    Has anyone tried to figure out what AZ-004 would be worth, if the FDA approves it?
    27 May 2010, 06:57 PM Reply Like
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