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

Shares of Vivus (NASDAQ:VVUS) lost over 50% in after-hours trading last evening following the Endocrinologic and Metabolic Drugs FDA Advisory Panel vote of 10-6 against whether the overall risk-benefit of QNEXA is favorable to support approval. The PDUFA action goal date is 10/28/10 under a standard 10-month review for an expected FDA decision.

During after-hours trading on Thursday, shares of Arena Pharma (NASDAQ:ARNA) (lorcaserin) rallied 15% while Orexigen Therapeutics (NASDAQ:OREX) (CONTRAVE) shed 10% as ARNA appears to be the market favorite at the moment in the race for an FDA-approved obesity / weight loss drug, in addition to being the only company of the three with pending FDA decisions that has recently signed a partnership with Japan's Eisai (OTC:ESALY).

Angiodynamics (NASDAQ:ANGO) reported its fiscal 4Q10 financial results yesterday and recently updated the status for its ongoing pilot study for the NanoKnife Irreversible Electroporation (IRE) System (a minimally-invasive tissue ablation device). On 4/20/10, ANGO announced that the first patient was treated in this pilot study for the treatment of early stage primary liver cancer (hepatocellular carcinoma or HCC), which is being tracked as ClinicalTrials.gov ID NCT01078415 with results expected mid-2011.

Below are summaries of the most recent articles written by Mark Messier at www.BioRunUp.com - please visit the site to read the full articles, in addition to many other free tools and strategies related to binary event investing...

FDA Calendar Updates 7/16/10

Posted: Fri, 16 Jul 2010 09:30:43 +0000

Protalix (AMEX:PLX) - PDUFA Date set for 2/25/10 CPIX - Priority PDUFA date of 9/30/10 Keryx Biopharma (NASDAQ:KERX) - Granted Orphan Drug Status (No PDUFA date)

Run-Up Schedule of Trades

Posted: Fri, 16 Jul 2010 09:30:06 +0000

This is a tentative list and may change at a moments notice, but I thought it would be a good idea to post what I am planning to do with my own trading account over the next few months.  I will update this post as situations change.  Remember- do your own research and make your [...]

VVUS- An Example of Why to Use the Run-Up Method

Posted: Thu, 15 Jul 2010 20:46:56 +0000

This afternoon the FDA Advisory Panel voted 7 Yes to 9 No that the FDA should approve Vivus' QNEXA.  Shares of VVUS fell into the low $4 range when the market opened after hours on Thursday.  This is a huge drop from the $12 - $13 VVUS has been trading at within the past few [...]

www.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. The HavRx Regulatory Catalyst Index update report is currently tracking 601 entries and 405 companies (with approximately 200 stocks trading under $5 per share and 65 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