Nanosphere, Inc. (NSPH) $3.40, up $0.17 (5.26%)
Nanosphere continues to move up on bullish chart technicals and speculative fundamental sentiment after its August 7 earnings call indicated the company was rolling out its Verigene System on better than expected demand. The Verigene System enables genomic and protein testing on a single platform. This System includes a bench-top molecular diagnostics workstation with nanoparticle technology that provides the ability to run multiple tests simultaneously on the same sample. A break out over $4 dollars a share looks to be on the horizon in my opinion. My recent feature article covering Nanosphere has more detailed information about the company for those who might be interested in researching this one further.
Arena Pharma (NASDAQ:ARNA) $8.28 up $0.02 (0.22%)
Arena trading has been mostly flat today after yesterday's strong move from $7.24 to $8.26 on 26,924,400 shares traded. Many sources I have spoken to about this move say it was in part fueled by acquisition speculation. Arena to date is up massively from a 52 week low of $1.23, rallying as high as $13.50 after the FDA approved its weight loss drug Belviq in June.
Amarin Corp. (NASDAQ:AMRN) $11.96, down $0.24 (1.97%)
Amarin is expecting an FDA orange book decision on New Chemical Entity (NCE) status as early as the end of this week for it's recently FDA approved Vescepa -- a prescription-only omega-3 fatty acid comprising icosapent ethyl, or ethyl-EPA for the treatment of patients with moderately to extreme elevated levels of high triglyceride levels or hypertriglyceridemia.
Vascepa hopes to compete with GlaxoSmithKline's (NYSE:GSK) 1 billlion dollar drug Lovaza. Both Vascepa are Lovaza are essentially pharmaceuticalized fish oil drugs that went through the full phase 1-to-phase 3 process, and are now approved by the U.S. Food and Drug Administration (FDA) for treating very high triglyceride levels.
It is my opinion that Amarin has a 70/30 chance to receive NCE status for Vescepa. If FDA wasn't prepared to provide Amarin with the eight or so years of market exclusivity that comes with NCE status, would the agency really demand the conduct of an 8,000-patient cardiovascular outcomes study that will cost $120 million?
Cornerstone Therapeutics (CRTX) $7.30, up $0.15 (2.10%)
Cornerstone continues to move up ahead of its PDUFA date of October 29th, 2012, for CRTX 080, indicated for the treatment of hyponatremia. An advisory committee first will meet on September 13th which will decide whether or not to recommend the drug for approval.
I believe the committee will give a recommendation to approve CRTX 080 for the sole reason the FDA has been under considerable pressure from the Obama administration to get these types of drugs out on the market. Therefore, I place the odds for a favorable recommendation from the advisory committee at 75/25.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Additional disclosure: Family Member holds NSPH stock. Disclaimer: This article is intended for informational and entertainment use only, and should not be construed as professional investment advice. They are my opinions only. Trading stocks is risky -- always be sure to know and understand your risk tolerance. You can incur substantial financial losses in any trade or investment. Always do your own due diligence before buying and selling any stock, and/or consult with a licensed financial adviser.