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Andrew Nava
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Andrew Nava LLC is a healthcare focused consulting and investment firm. Prior to launching Andrew Nava LLC, I was a venture analyst, buy-side analyst, and most recently, the Director of Research at Actin Biomed, a New York-based healthcare investment firm where I was responsible for the medical,... More
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  • GSK and Xenoport Meet with FDA to Discuss Horizant Complete Response Letter 0 comments
    May 26, 2010 12:33 PM | about stocks: XNPT

    In an 8-K filing today, Xenoport (NASDAQ:XNPT) disclosed that on May 18, 2010, along with GSK, it conducted an end-of-review meeting with the FDA to discuss the Complete Response letter (NYSE:CRL) resubmission regarding the Horizant (gabapentin enacarbil) NDA for moderate-to-severe primary restless legs syndrome (RLS).

    XNPT stated that the FDA is suggesting additional preclinical data and data analyses which may be useful in the evaluation of the resubmission. The good news (for investors who were shocked by the FDA's decision) is that no new clinical trials are expected at this time. XNPT says it expects the CRL resubmission will be filed with the FDA in the second half of 2010.

    As a reminder, XNPT's stock price was vaporized in February 2010 after the FDA issued a CRL for the Horizant NDA for RLS citing that "a preclinical signal of pancreatic acinar cell tumors in rats was determined to be of sufficient concern to preclude approval of the Horizant NDA for RLS in its current form."

    Stay tuned...

    For a full list of company catalysts, including CRLs, NDAs, PDUFAs, expected clinical trial results, and much more, visit www.andrewnava.com

    Andrew Nava LLC provides institutional and retail healthcare investors with buy-side equity research tools which focus on value-driven investing, profitable trading ideas and clinical, commercial, and regulatory catalysts. Our research is supported by consulting with KOL's, industry professionals, company management, and our database of clinical trial data and upcoming company milestones.


    Disclosure: No positions

    Stocks: XNPT
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