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  • XNPT XenoPort, Inc. PDUFA date set. 0 comments
    Feb 20, 2011 4:26 PM | about stocks: XNPT

    XenoPort, Inc. (NASDAQ:XNPT): Nasdaq are a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body’s natural nutrient transporter mechanisms to improve the therapeutic benefits of drugs. Our most advanced product candidate is currently being evaluated in a Phase 3 clinical program for the treatment of restless legs syndrome, or RLS. RLS is a common, under-diagnosed neurological condition that frequently manifests itself as a sleep disorder. This product candidate has also successfully completed a Phase 2a clinical trial for the management of post-herpetic neuralgia, or PHN. PHN is a chronic type of neuropathic pain, which is pain resulting from nerve damage. Our second product candidate has generated positive data in a Phase 2a clinical trial for reducing the number of reflux episodes in patients with gastroesophageal reflux disease, or GERD.

    Upcoming Catalysts for the first half of 2011

    Catalyst 1
    Arbaclofen placarbil also known as XP19986 is in Phase 2b clinical development for the treatment of gastroesophageal reflux disease, or GERD, and for the symptoms of spasticity. XenoPort currently holds all rights to this product candidate and top-line results are expected from now to the end of the 1st quarter of 2011  (NCT00978016).

    Arbaclofen placarbil also known as XP19986

     

     
    Catalyst 2
    XP13512, Brand Name, Horizant(NYSE:TM). The Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for Horizant for the treatment of moderate-to-severe primary restless legs syndrome (RLS) is April 6, 2011. Horizant is licensed to GlaxoSmithKline in the United States and several other countries.

    Horizant(TM) also known as XP13512

     

     

    About Horizant(TM) and FDA Approval
    As most new drugs, Horizant(TM) has had its fair share of problems with the FDA on getting an approval. On Feb 17, 2010 they received the dreaded CRL letter issued by the FDA's Center of Drug Evaluation and Research in which the FDA indicated that a preclinical finding of pancreatic acinar cell tumors in rats was of sufficient concern to preclude approval of Horizant for RLS at this time. FDA acknowledged that similar findings were known for gabapentin at the time of its approval for refractory epilepsy, but concluded that the seriousness and severity of refractory epilepsy justified the potential risks. This of course had a devastating effect of the share price of XenoPort, Inc. sending the $19.60 share price to a new all-time low of $6.39 with a close of $6.67. As with most crushed drug stocks it rebounded over the coming months never recovering from the major blow by the FDA.

    On Nov 05, 2010 XenoPort, Inc. announced that the U.S. Food and Drug Administration (FDA) had accepted for review GSK's response to FDA's Complete Response letter for Horizant(TM) (gabapentin enacarbil) Extended-Release Tablets. Horizant is under review for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA has designated the resubmission as a Class 2 response and set a new Prescription Drug User Fee Act goal date of April 6, 2011.

    Ok, so what's different and why was XNPT given another PDUFA date?. In the resubmission of Horizant to the FDA it also included safety updates and information in the clinical trials in patients who have been treated with Horizant(TM), and GSK amended the NDA from a 505(b)(1) to a 505(b)(2) application. What this means is that XenoPort, Inc. is now going for a 505(b)(2) application and will be able to use outside published non-clinical and historical studies and data for the FDA to consider, specifically studies to show if there is an association of gabapentin use with pancreatic cancer. Studies show high doses of gabapentin are associated with pancreatic acinar cell tumors in rats, but there has been no post marketing pancreatic carcinogenicity signal with gabapentin as reported by spontaneous reports in AERS or in the published literature. In a published case-control screening study of the association of gabapentin with 55 cancers, the only cancer that met the screening criteria for possibly increased cancer risk with gabapentin exposure was renal (including renal pelvis) cancer. This association was judged to be likely due to or substantially accentuated by confounding by cigarette smoking, hypertension, and lifestyle.  You can find more in-depth information provided by GlaxoSmithKline here at the ClinicalTrials.gov NCT01138124.

    Financings

    As of September 30, 2010, XNPT had cash and cash equivalents of $14,512,000 and they also did a finance deal on Dec 09, 2010 for 4,000,000 shares of its common stock at a price to the public of $7.15 per share and a 30-day option to purchase up to an aggregate of 600,000 additional shares of common stock.

    Shares Outstanding

    As of October 15, 2010; 30,576,614 shares of the registrant’s common stock were outstanding.

    Shares Short

    Shares Short (as of Jan 31, 2011) were 2.48M shares. Shares short prior month was 2.29M this is an approximate figures.

    Trading Range

    The 52 week trading range is $5.66 – $11.82. Shares finished at $7.45 on Friday 18th Feb 2011.

    Analyst Ratings

    Although the ratings are more than 7 months old the price targets for XNPT range from $6.00 low end to a high end of $26.00.

    Investor Relations

    XenoPort, Inc.
    3410 Central Expressway
    Santa Clara, CA 95051
    Phone: 408-616-7200 E-mail: IR@XenoPort.com

    In our opinion, XenoPort, Inc. would be a risky trade to hold through the PDUFA date, but short term, we could or might see some value as the share price is not trading too much higher than the finance deal they completed in December for $7.15. Also, we have the Phase 2b that could come at anytime on XP19986. A little more risk is involved by buying before the data is released, but even if the data is good the markets seem to be selling on the news, no matter what or how good the data is. The PDUFA catalyst could or might start to add shareholder value to XenoPort, Inc., we have 33 trading days left before the X date. We like to think we might even see a pre X price range of $9.00 to $9.50 + if the markets hold up and there are no delays in the PDUFA date. XNTP has yet to start its run up, although we feel that there is more risk involved with the 2b data. This could or might start the catalyst whatever way the clinical results fall.

    Always use your stop loss to limit your downside and know your sell targets before you trade if you trade any securities.
     



    Disclosure: I am long XNPT.
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