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mikehavRx.com News Bytes: $EXAS, $ITMN, $FACT, $ABT
Click here for a link to my coverage of EXAS at Seeking Alpha over the past three years, which has been a wild ride for long-term shareholders. However, with a new management team in place from Third Wave and pending external validation study results from Mayo Clinic for the Company's stool DNA (sDNA) based colorectal cancer (CRC) screening test kit; the future looks very bright given the U.S. market alone of approximately 90 million over the age of 50 who are not being screened adequately for CRC. It is important to note that the Company's sDNA test kit for CRC is not meant to replace colonoscopy, but is being developed as a more effective population-based, non-invasive first-line screening tool to integrate / replace FIT / FOBT based tests which simply detect the presence of blood in the stool rather than genetic mutations associated with CRC - the key distinction is the potential for a much higher rate of detection for pre-cancerous polyps and early stage disease for sDNA testing. EXAS has provided guidance for external validation study results during 2H10, which will lead to a pivotal clinical trial to support FDA marketing clearance and possible commercialization of the test in 2012. Shares of InterMune (NASDAQ: ITMN) are surging today ($38.50, +65%) on heavy volume after a FDA Panel voted to recommend approval of the Company's experimental lung drug, Esbriet (pirfenidone) for a condition known as idiopathic pulmonary fibrosis (IPF), with a final decision by the Agency expected by early May. Shares of Facet Biotech (NASDAQ: FACT) are trading near $27 per share (+66%) after a takeover offer by Abbott Labs (NYSE: ABT). The deal follows a rejected offer late last year from Biogen-Idec (NASDAQ: BIIB) for $17.50 per share, which proved to be a prudent decision by FACT shareholders. The ABT deal is expected to close 2Q10 and FACT's lead experimental multiple sclerosis (MS) treatment daclizumab is expected to begin a Phase 3 pivotal study during the same time frame. mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed HavRx Regulatory Catalyst Index. Please visit www.mikehavRx.com for more details. Disclosure: Long EXAS |
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