Trading FDA, Clinical Trial Binary Events: $BIIB $BNC.TO $HGSI $JAZZ $QCOR $NVS

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

Biogen Idec (NASDAQ:BIIB) announced yesterday that it made an equity investment and deal that included potential license payments up to $345M with Pittsburgh, PA based Knopp Neurosciences for KNS-760704 (dexpramipexole) (oral, neuro-protective compound), which is being developed for treatment of amyotrophic lateral sclerosis (ALS) (Lou Gehrig’s disease). The compound has both FDA Orphan Drug and Fast Track status and BIIB expects to begin the Phase 3 clinical development program during 1H11.

Bioniche Life Sciences (BNC.TO) (BNHLF.PK) announced plans with partner Endo Pharma (ENDP) to begin an additional Phase 3 study by year-end 2010 for UROCIDIN (a intravesical formulation of Mycobacterial Cell Wall-DNA Complex or MCC) and ENDP is expected to complete analysis by the end of September for 12-month data for a Phase 3 study conducted in patients with non-muscle-invasive bladder cancer refractory to current therapy.

Human Genome Sciences (NASDAQ:HGSI) announced FDA priority review (six-month) designation for BENLYSTA (belimumab), which is seeking approval for treatment of systemic lupus erythematosus (SLE) along with partner GlaxoSmithKline (NYSE:GSK).

Privately held Quark Pharma announced a licensing option agreement yesterday with Novartis (NVS) for QPI-1002 (p53 inhibitor siRNA compound), which is being evaluated in a Phase 2 study for the prevention of acute kidney injury (AKI) in patients undergoing cardio surgery and for delayed graft function (DGF) in kidney transplant patients.

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

Jazz Pharma (NASDAQ:JAZZ) FDA Advisory Panel Notes Released

This morning the FDA released the Advisory Panel’s briefing documents. (Link)  First of all, congrats to longs. For your sake I hope the panel goes well and JAZZ rockets up in value. Looking at the current market price ($11.25) I have a few thoughts: – Was it worth the risk? Many sold JAZZ a few [...]

Rolling a Percentage of JAZZ Profits into Risky Questcor Pharma (NASDAQ:QCOR) Calls

Back in June we released an article entitled “Using 10% of Run-Up Gains for Risky FDA Decision Plays” .  This strategy involves risking “house money” (profits) into potential exponential growth.  One of the best ways to do this is trading options.  When risking money in the stock market- and ESPECIALLY when trading options, you must [...]

Reminder- Get the Most out of BioRunUp.com

We have gained quite a few subscribers over the past month and we have been adding features to the site, so we wanted to post a reminder outlining the different features of BioRunUp.  This will allow our users to get the most out of the site.  Take a look at the following: Email Updates /Alerts [...]

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