Mike Havrilla's  Instablog

Anadys Pharma (NASDAQ:ANDS) announced that six patients (100%) receiving 200mg twice daily of ANA598 (a direct-acting anti-viral agent against hepatitis C virus or HCV) maintained undetectable levels of HCV at 12-weeks post-treatment (Sustained Virological Response 12 or SVR12). Additional post-treatment results from other treatment arms in the ongoing Phase 2 study are expected later this year.

Bionovo (NASDAQ:BNVI) announced today that it received final guidance from the European Medicines Agency (EMA) for conducting a pivotal Phase 3 study of MENERBA for menopausal symptoms. In addition, BNVI has conducted a meeting with the FDA for the US development plan and will provide more details when the minutes from this meeting are released.

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...

Amarin Corp. (NASDAQ:AMRN) -- Clinical Trial with Upcoming Catalysts

Posted: 29 Jul 2010 02:38 AM PDT

I respect Mike Havrilla as a person, pharmacist, and trader, so when I found out that he expressed much confidence in a clinical trial, I wanted to learn more.  I am passing this information on to my subscribers. I currently have no position in AMRN, but I am looking to open one after the October Run-Ups. For [...]

EXACT Sciences (NASDAQ:EXAS) Updates - Detection Technology Achieves 100% Sensitivity

Posted: 28 Jul 2010 07:38 AM PDT

This post is to update you on some recent developments and research done on EXAS.  Clink on the title to read the article we published on Monday: "EXAS- Data Validation Study with a 10/29/10 Catalyst Date". Today, July 28th Exact Sciences reported their Q2 earnings.  Some of the highlights include: Financial Information Exact reported total [...]

Below is a summary of my recent real-time trading updates posted yesterday on the BioRunUp.com Forum...

With the run-up in EXAS shares over past few days, none of my orders got filled so I decided to buy back into AMRN today with a little less money on the table (withdrew approx. $27K for non stock related investments)...I expect some cash to free up ahead of 29-Oct results for EXAS and may take a position on any pullbacks or just pile into AMRN over the next few months...

AMR101 (Ethyl-icosopentate or Ethyl-EPA) (Prescription-Grade Omega-3 Fatty Acid) -- Pivotal Phase 3 MARINE (NCT01047683), ANCHOR (NCT01047501) Clinical Trials under SPA (ClinTrials.gov IDs) (6-8 week run-in periods prior to the12-week treatment periods). AMRN is fully funded through a potential NDA filing with ongoing partner talks. My estimate for MARINE study to be fully randomized is 3Q10 (early AUG) and to complete the study by end OCT for potential results by year-end 2010 in DEC or early 2011. My estimate for the ANCHOR study to be fully randomized is during 4Q10 with potential results during 1-2Q11.

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 617 entries and 428 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: Long AMRN

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.

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 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

On 7/27/10, Antares Pharma (AMEX:AIS) announced that its pivotal study for ANTUROL (transdermal oxybutynin ATD gel) met the primary endpoint with a statistically significant reduction in urinary incontinence episodes for both doses evaluated (56 / 84mg daily). An open-label extension study is ongoing to assess safety and is expected to be completed by 4Q10 with plans to file a New Drug Application (NDA) by year-end.

On 7/27/10, Hologic (NASDAQ:HOLX) announced that a meeting of the FDA Radiological Devices Advisory Panel is scheduled for 9/24/10 to review the Company's PMA submission for the Selenia Dimensions 3-D Digital Mammography Tomosynthesis System, seeking marketing clearance as a new method (3-D vs. 2-D imaging) for breast cancer screening / diagnosis.

On 7/27/10, Omeros (NASDAQ:OMER) announced that the first patient was enrolled in a Phase 2b study to evaluate OMS302 (anti-inflammatory plus pupil dilating Pharmaco-Surgery combo agent) following cataract eye surgery. OMER plans to enroll about 200 patients and advance the compound into Phase 3 development in 2011 contingent upon successful completion of the Phase 2b study.

Caraco Pharma Labs (AMEX:CPD) reported its quarterly results and provided an update following the June 2009 seizure of inventory from is MI manufacturing facilities and FDA Consent Decree. CPD is working with cGMP consultants to regain FDA compliance, and the Agency replied on 6/24/10 that the protocol to re-gain compliance was acceptable. As of 6/30/10, CPD has 33 pending ANDAs at the FDA, which includes 29 products and four tentative approvals.

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 617 entries and 428 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