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Trading FDA, Clinical Trial Binary Events: $ATHX $AZN $VRTX $MKGAY

By Mike Havrilla on 07/28/2010 – 2:14 pm PDTLeave a Comment

Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news….

On 7/28/10, Athersys (NASDAQ:ATHX) announced positive results and no safety concerns in a Phase I study following acute myocardial infarction (MI or heart attack) based on four-month post-treatment data for MultiStem (Adult Progenitor or MAPC Stem Cell Technology), which is partnered with Angiotech Pharma (NASDAQ:ANPI). Additional data will be presented from the study on 9/22/10 in Washington, D.C. at the Symposium “Strategies for Cardiovascular Repair: Stem Cell Therapy and Beyond,” at the Transvascular Cardiovascular Therapeutics Conference.

The Cardiovascular and Renal Drugs FDA Advisory Committee voted 7-1 this afternoon in favor of approval for BRILINTA (ticagrelor) as an oral anti-platelet treatment (blood thinner to reduce incidence of clots, etc.) for the reduction of major adverse cardiac events in patients with acute coronary syndrome. A final FDA decision is expected by 9/16/10.

Vertex Pharma (NASDAQ:VRTX) reported its quarterly results today and provided guidance to report pivotal ILLUMINATE Phase 3 data for Telaprevir (VX-950 or TVR) in August and REALIZE (treatment failure hepatitis C virus or HCV patients) Phase 3 data in September. VRTX expects to complete its rolling New Drug Application (NDA) filing by year-end.

Merck KGaA (OTC:MKGAY) announced that the FDA accepted its NDA for Cladribine Tablets (oral, experimental compound for multiple sclerosis or MS) and issued a six-month priority review with a final decision by the Agency expected during 4Q10. In addition, the Company expects a European Medicines Agency (EMA) decision during 3Q10 and previously announced marketing approval in Russia earlier this month. 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. The HavRx Regulatory Catalyst Index update report is currently tracking 618 entries and 429 companies (with approximately 200 stocks trading under $5 per share and 78 private companies). Click here for a subscriber overview article that includes an email archive web link for a 50% discount ($150) promo code off the regular one-year, non-recurring subscription price.

Disclosure: No positions

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