CXS 0.00% 70.0¢ chemgenex pharmaceuticals ltd

this stock is da bomb, page-14

  1. 664 Posts.
    from RBS...

    ChemGenex (CXS) has two key milestones approaching. Firstly, we are expecting the
    US FDA to provide CXS with a priority review date next week. Secondly, we are
    expecting a partnering deal (ex-US) to be signed before Christmas. Buy CSX today in
    anticipation of the FDA granting priority review over the weekend and trade the stock
    as the two key milestones are achieved.

    Table 1 : Milestones to focus on
    Estimated date Milestone Impact
    Achieved Complete submission of rolling NDA for Omapro to the FDA Positive
    November 2009 FDA decision on whether Omapro is eligible for Priority Review Positive
    End CY09 Complete non-US partnering discussions concerning Omapro Major positive
    4QCY09 Initiate European regulatory filing for Omapro Positive
    2QCY10 Anticipated approval and commercial launch of Omapro in the US Major positive
    3QCY10 Anticipated approval and commercial launch of Omapro in EU Major positive

    The biotech sector has matured significantly
    Life science stocks have long been considered speculative. While still high risk, we believe
    the sector has matured significantly over the last three years, with a number of companies
    reporting late stage clinical trial results, applying for product approvals or being acquired. To
    this end, we closely monitor approaching milestones of a number of the life science
    companies, with the goal of clearly highlighting potential value inflection points. Cancer
    company ChemGenex (CXS), has two key near-term milestones, which if achieved will be
    significant for the company and may lead to a rerating of its shareprice. We always
    acknowledge the higher risk nature of these companies and encourage investors to take
    profits once milestones are achieved.
    Receipt of priority review would be positive, as it sets out a schedule for approval
    CXS’ lead drug, Omapro, is under development to treat a type of leukaemia. In early
    September 2009, CXS announced submission of its New Drug Application (NDA) to the US
    FDA for Omapro. As part of this CXS applied to the FDA for Priority Review. For products
    believed to address unmet needs (like Omapro), the receipt of Priority Review can shorten
    the average amount of time from application to a decision by the FDA on whether to approve
    the drug for sale, from 10 months to 6 months, accelerating market launch and ultimately
    revenues. We expect CXS to receive notification on whether or not it is eligible for priority
    review in early November (our estimate is 8 November US time - which is this weekend). If
    priority review is received, we expect the FDA to make a decision on whether to approve
    Omapro for sale in early March; a company making event. If priority review is not received in
    November this would be negative for sentiment, although it is unlikely to have a material
    impact on the company’s long term ambitions.
    European partner due to be announced by year-end
    The next milestone we are focused on is a partnering deal for Omapro in Europe, which is
    expected before the end of CY09. If achieved, this will be a major positive for CXS and will
    reduce the need for additional capital to be raised to fund the US launch in CY10. Buy CXS
    today in anticipation of the FDA granting priority review over the weekend and take some
    profits as the two key milestones are achieved.
 
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