The broad markets have taken an early-week swan dive, chiefly due to concern about the health and future of the European economy, but there are still some hot companies to keep an eye on as they make headlines this week.
Amarin Corporation (NASDAQ:AMRN): Amarin is just a day away now from the expected approval decision by the FDA regarding AMR-101 for the treatment of high triglycerides. AMRN shares have already been on the rise over the past few months in anticipation of this date, but have declined during the opening of this trading week. Much of that decline could be attributed to the market sell-off, but investors are still banking on an approval with a determination that AMR-101 will also receive a new chemical entity [NCE] status, a designation that would add five years to the product's market exclusivity.
Amarin is also a hot one to watch for the buyout or partnership speculation that surrounds the key FDA approval date. Many believe that a deal with a still unknown entity is already essentially in place, with the final word on FDA approval and NCE status being the last formalities before calling it a done deal.
The strong buyout speculation may be enough to help Amarin shares to buck the current trend of companies experiencing heavy sell-offs following positive FDA approval decisions, but if such an announcement does not materialize quickly, then AMRN could drop. Shares have already fallen from nearly twenty dollars at one point when a rumored buyout did not become a reality.
A hot one to watch right now.
Sunshine Heart (NASDAQ:SSH): Shares of Sunshine Heart were moving big during the pre-market on Wednesday after the company announced that it had received CE Mark Approval in Europe for its C-Pulse Heart Assist device in the treatment of heart failure.
Sunshine was already one of the biggest winners earlier this week when the company again made the Nasdaq's list of early day gainers on Monday. Shares declined on Tuesday, however, as did most of the market.
After having ran from roughly three dollars to over seventeen in a short period of time early this month, Sunshine has since dropped back to the ten dollar mark, but events announced this week by the company, including a positive two year review of the first patient to have been implanted with the company's C-Pulse heart assist system in conjunction with its North America feasibility trial, stands as a reminder that the best may still be yet to come for this company.
Sunshine's C-Pulse Heart Assist device has been designed for the treatment of Class III and Ambulatory Class IV heart failure and has proven to control - and even reverse - the symptoms and progression of the disease. The latest data announced this week related to the feasibility trial, for which enrollment was completed in June of last year. Full data are expected later this year, around the same time that the company could register its first commercial sales in Europe, especially with the outcome of the CE Mark approval known..
According to Sunshine's Monday press release, Dr. Andrew Kao, Heart Failure Cardiologist at St. Luke's Hospital in Kansas City, MO, noted the following in regards to the subject patient receiving the two year review:
I witnessed this patient experience an amazing recovery of function. The first time I met him, he could not walk or even say a few words without extreme perspiration and shortness of breath. After C-Pulse implantation, he can do many more activities -- he can walk around comfortably and also has improved self-confidence.
Additionally, Sunshine also emphasized the positive trends in both efficacy and safety in regards to the six and twelve month follow-ups and noted that, thus far in clinical development, the C-Pulse system has proven to be more effective than current standards of treatment.
The C-Pulse technology falls well in line with today's healthcare trends of finding cheaper and more effective ways to treat what have previously been known to be very expensive and invasive conditions. C-Pulse is implanted with a minimally invasive procedure, which alone cuts monetary costs in relation to surgery and recovery. The system has also thus far demonstrated that it can reduce the number of a patients required visits to the doc while also enabling the target patient group to avoid the extended hospital stays that often accompany treatment - factors that help to reduce monetary costs behind treatment.
Another benefit is that the device is implanted outside of the blood stream, which offers extra convenience and quality-of-life improvements for a patient who is able to 'disconnect' the device at will, in order to shower, for example.
Volume has increased significantly, as well as price, and Sunshine has enough pending catalysts and past successes to keep this one on the radar.
Also keep this one on the list of potential buyout plays as C-Pulse could be a game-changer in the treatment of heart failure, should the encouraging results keep up.
Horizon Pharma (NASDAQ:HZNP): Horizon, like Amarin, also has a key date with the FDA set for Thursday, and shares had also been on a roll for weeks leading into this decisive day before a modest decline on Tuesday. Shares have more than doubled since early June when investors started taking positions in anticipation of the probable approval of the company's treatment for rheumatoid arthritis, Rayos. Horizon also has the already-approved osteoarthritis and rheumatoid arthritis drug, Duexis, on the market, although sales for that product have been modest, thus far.
The total market potential of both products is still a relatively unknown factor, especially considering that Rayos is considered a "me, too" drug by some since it is a controlled-release dosage of a product already on the market.
That said, as a catalyst play Horizon has already returned swift and steady gains and has received a boost from increasing institutional and hedge fund interest. While trading into Thursday's catalyst, investors may also take note that the current sector trend, as noted in regards to Amarin, has seen many biotech stocks drop after positive FDA approval decisions.
The same buyout and/or partnership speculation surrounding Amarin is not there - at least not on the same scale - as it is for Amarin, so any potential drop could be a bit more protracted. Should either of this company's products pick up steam on the market, however, additional future gains are possible, as HZNP still has a relatively speculative market cap.
Cytosorbents, Inc. (NASDAQ:CTSO): Cytosorbents has consistently been building momentum for its potentially breakthrough treatment for severe sepsis and other indications of high cytokines, and shares spiked by over twelve percent on Tuesday amid a market sell-off after the company received analyst coverage by Brean Murray, who initiated said coverage with a rating of 'Buy.'
This company's medical device, CytoSorb, is already approved in Europe and has recently been formally launched onto the commercial market in Germany. Given that the company is small in size and resources are limited, CEO Chan has taken a methodical approach in undertaking this commercial launch, but should CytoSorb demonstrate the commercial successes that were proven in trials, the potential for growth is unlimited as there is currently no effective treatment on the market to combat severe sepsis, and indications where high cytokines are present.
With that being the case, the product is currently going through a period of "I'll believe it when I see it" with medical professionals. While European authorities were compelled to approve CytoSorb before the European trial was even completed, based on the encouraging results, many still want to see results from a larger trial - or commercial success stories - before giving CytoSorb widespread acceptance.
Cytosorbents is currently in preparations to conduct a larger trial in the United States, with FDA approval as the ultimate goal.
Given the potential of this company's blood purification technology, CTSO shares could be heavily discounted right now. Based on its potential, look for the company to eventually seek to trade on a larger exchange as the stock and product gain more widespread attention.
For a developmental company going commercial, the new analyst coverage is huge, as evidenced by Tuesday's twelve percent price spike.
Another hot one to watch?