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Trading FDA, Clinical Trial Binary Events:$BPTH.OB $OREX $VRUS $ARNA

publication date: Jul 30, 2010
 | 
author/source: Mike Havrilla
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Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...

On 7/29/10, BioPath (OTCBB:BPTH) announced that the first patient was dosed in a Phase I study of Liposomal Grb-2 (BP-100-1.01) (anti-sense, nucleic acid anti-cancer agent). The study includes patients (18-30) with chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS) with an estimated cost of $2 million and ClinicalTrials.gov ID NCT01159028.

Orexigen Therapeutics (NASDAQ:OREX) announced publication of Phase 3 data for CONTRAVE 32 (32mg naltrexone SR + 360mg bupropion SR) in the medical journal Lancet with 62% patients who completed the study losing at least 5% of body weight vs. 23% on placebo. OREX has an upcoming Metabolic and Endocrine Drug Products FDA Advisory Panel meeting scheduled for 12/7/10 and a PDUFA action goal date of 1/31/11 under standard 10-month review for an expected FDA decision.

On 7/28/10,Pharmasset (NASDAQ:VRUS) initiated a Phase 1b multi-ascending dose study for PSI-938 (a third generation purine nucleotide analog polymerase inhibitor of hepatitis C virus), which adds to an ongoing Phase 1a single-ascending dose study. The Company expects to report results from both studies by the end of this quarter.

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...

EXACT Sciences (NASDAQ:EXAS) - Clinical Trial Results for ColoRectal Cancer Screen 10/29/10

ALR Technologies (OTCBB:ALRT) - FDA 510(k) Filing for Health-e-Connect (HeC) System - Health Care for Diabetes Patients.  ESTIMATED Date of 3/31/10

Hologic (NASDAQ:HOLX) - FDA Advisory Panel for breast cancer screening / diagnosis on 9/24/10

AstraZeneca (NYSE:AZN) - FDA PDUFA for Brilinta 9/16/10

Merck KGaA (OTC:MKGAY.PK) - FDA Priority Review for Cladribine Tablets 12/8/10

Arena Pharma (NASDAQ:ARNA) - A "Poster Child" for Run-Ups

We first discussed ARNA back on May 20th, back when ARNA was $2.90 a share. That is a far cry from today's close of nearly $7 per share.  Take a look at the incredible chart for ARNA over the past few months.  Can ARNA maintain this momentum up to the FDA Panel on September 16th?  Can the 200% price increase hold...

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 619 entries and 430 companies (with approximately 200 stocks trading under $5 per share and 79 private companies). Click on the following email archive web link for a 50% discount promo code and for more details on the mikehavRx.com Personalized VIP service... http://eepurl.com/L7y1

Disclosure: No positions

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www.mikehavRx.com is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and binary event tracking for FDA decisions and clinical trials, including 600+ events and 400+ companies with approximately 200 stocks trading under $5 per share and 80+ private companies. The home page includes an overview of the binary event tracking service and the secure checkout page includes currently offered discount promo codes at https://mikehavrx.ssl.subhub.com/subscribe