Shares of Amarin Corp (AMRN) were setting new 52-week highs during early trading on Thursday as investors jumped in to take positions before next week's key date when the FDA is set to render a decision on the approval of AMR-101 for the treatment of high triglycerides. As noted earlier in the week, approval is all but assured - at least according to most investors and analysts who believe in the very strong Phase III data registered by AMR-101 - especially after a curious "gaffe" on Thursday morning, seemingly by Amarin itself, that sparked a rally and led to the setting of the new 52-week high.
A website advertising the "FDA approved" Vascepa drug - AMR-101 - briefly came on line on Thursday morning, hinting to investors that the company has already received notification from the FDA that the product was approved - even though no such formal announcement has been made. The site was quickly taken back off line and Amarin issued a statement regarding the incident via an 8k filing stating that the information on approval "was inadvertently published through a draft website that is under design by third parties on behalf of Amarin. The information was outdated and should not be relied upon as accurate. AMR101 review at FDA is still pending. No determinations have been made by FDA on its review of the AMR101 New Drug Application ("NDA")."
Regardless of what the company said about the incident, the rumor mill is swirling.
Theories are circulating that the company 'accidentally-on-purpose' wanted to give the investing community a heads up that approval was coming to drive the shorts out of the stock in order to allow the share price to run, while other theories believe that the intended run is to boost the value of the company in preparation for buyout offers.
Many also believe that this was a clear sign that Amarin already has a partnership in hand, pending the products approval, and the product is soon set to hit the open market following an official FDA announcement.
AMRN shares retreated later in the day, although still closed up by fiver percent, and are likely to receive a fair amount of attention over the next week in the biotech and healthcare sectors now that most of the hype and drama surrounding the approval of both Vivus' (VVUS) and Arena's (ARNA) weight loss pills is in the rear view mirror.
Website "gaffe" or not, Amarin's AMR-101 is looking more and more likely to receive approval and become the blockbuster that everyone seems to believe it can be. Even with the recent runup, it's still quite the 'buyout play'. Much of the speculation over the past 24-hours revolves around a deal already being done with Pfizer (PFE), a company on the prowl for another blockbuster or two after suffering from the expiration of key patents over the past couple of years.
Now is not the time to let this one slip off the radar - we're still likely to see some more day, swing, momentum and catalyst traders enter the stock and drive prices higher.
Disclosure: Long AMRN.
Disclosure: Long CELH. May purchase long shares in MRIC, SSH within the next 72 hours.
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