Stocks and Stories to watch this week:
DNDN: As the aftermath from the Dendreon fallout continues to play out in the healthcare and cancer immunotherapy sectors, the company recently announced a round of mass layoffs resulting from the failure of Provenge to sell at rates previously expected by the company and investors.
Roughly 25% of the Dendreon work force is slated to be cut in order to reduce expenses, while the sales team will be on a campaign to spread awareness and "education" to Doctors about the ease of ensuring reimbursement for the expensive Provenge treatment.
Volatility should be expected for this company over the coming months, until sales guidance and revenues match up, and as many investors debate whether the 'Golden Age' for Dendreon has fizzled before it even gathered momentum.
On another note, the stock price crash and reduced market cap could have this company looking like a merger or acquisition candidate to a larger pharmaceutical. There's little doubt that a strong, brand-named sales force might be able to influence Provenge sales on a grander scale than what's been seen thus far.
Still, Provenge revenue is increasing, just not at the levels expected in order to meet the company's previously-estimated $350-$500 million for 2011.
AMPE: Ampio Pharmaceuticals (AMPE) has returned a near double in just over a month's time as shares closed last week above the nine dollar mark. Multiple near term pipeline catalysts are beginning to play out as expected, and there's still yet more to come on the catalyst front that have the potential to push shares even higher.
Ampio announced a licensing deal with Daewoong Pharmaceuticals for its erectile dysfunction (ED) product Zertane in South Korea earlier this month, a deal that will bring in millions in an up-front payment, with additional milestones and a 25% royalty also written in.
Company officials have indicated a large amount of partnership interest for Zertane from countries around the globe since publishing positive results of a European trial back in June of 2011. The Daewoong deal illustrates that Ampio is following through on its strategy of landing regional partners for its products, rather than concentrating on one global partner who might not have the local influence as regional distributors.
Look for updates on other trials, as well.
Ampion for osteoarthritis (OA) in the knee and Optina for diabetic macular edema (DME) and diabetic retinopathy results are also due out before the end of the year.
TTNP: It's been crickets surrounding Titan Pharmaceuticals (TTNP.ob) since announcing positive results from a confirmatory Phase III trial for Probuphine in the treatment of opioid addicition earlier this year. While the confirmatory trial proved positive, as did previous trials, the path to approval for Probuphine is still not entirely set in stone.
A Pre-New Drug Application (Pre-NDA) meeting is scheduled for late October where a strategy should be agreed upon for bringing Probuphine to market, and Titan should be providing a full briefing document to the FDA in mid-September in preparation for the meeting.
Probuphine is an subcutaneous implant that delivers a steady, round-the-clock dose of buprenorphine over a six month period following a single treatment, alleviating the potential for patients to overdose or abuse their treatments.
Aside from the potential for Titan's novel ProNeura treatment to see market in the form of Probuphine, recent reporting has also identified the company as a potential buyout candidate.
Titan is not one to forget about as investors await news on the FDA approval path and volatility drives the speculative market lower.
CTSO: After seeing a brief spike in share price following the announcement of secondary results from the European trial for Cystosorb, shares of Cytosorbents (CTSO.ob) continue to trade for under two dimes as the company moves from the developmental to commercial phase.
Results from the trial were compelling enough for Cytosorbents to receive a CE Mark approval in Europe, but the slow and methodic roll-out of Cytosorb - which begins in Germany - requires patience as the plan unfolds.
Even as positive developments continue to unfold in regards to Cytosorbents and its flagship treatment, there's still enough time between the present day and full commercialization to where speculation and volatility can still play with the CTSO share price.
Given the market potential of the product, investors will want in before mass commercialization takes place. As speculative as this play has been over the past year, it's quickly becoming game time for Cytosorbents, meaning the day/swing/momentum traders are going to fly in and out, and long termers will start taking up their positions.
Each time CTSO pops, high volume comes in to take the price right back down, giving those investors the opportunity to re-load.
This company is sporting a potentially groundbreaking product in a field that shows a relative lack of adequate competition, and the story continues to develop. New statistical analysis was presented at the Rodman & Renshaw Global Investment Conference last week, and interest in Cytosorbents could continue to grow.
Might continue to be a 'buy the dips' kind of play until revenue starts rolling in to stabilize the situation.
GERN: Shares of Geron are still hanging out at the sub-$2.50 levels, a far cry from the near one billion dollar market cap that GERN enjoyed at the height of the stem cell research hype.
The stock is trading just above its 52-week lows, but the potential that everyone bought into to drive the stock to its previous highs still remains.
Geron is developing treatments for multiple indications utilizing embryonic stem cell technology and has a Phase I trial underway for spinal cord injuries. The company also has trials for cancer treatments in Phase II.
While trading in the mid two dollar range, it might be easy to ignore the potential of Geron, but it's hard to imagine that the arguable leader of the embryonic stem cell generation will remain repressed for too long.
As the market recovers and trials progress, look for a rebound in price.
OVIT: Here's one that might start making some noise again.
Oncovista has been relatively dormant for a while, and as a result the market cap of the company sits at ten million with a share price that hovers right around fifty cents.
Limited capital resources have hampered the forward progress of the pipeline through the height (or depths) of the global economic crisis, but there might be enough juice to spark some life in the pipeline over the short term.
The company's technology is geared towards developing personalized, efficacious cancer treatments based on specific biomarkers to detect metastatic tumors. The most advanced product, Cordycepin (OVI-123), is being tested in Phase I/II trials for treatment in patients with refractory leukemia. Although this trial had been placed on hold due to the company's limited resources available, a recent quarterly filing has indicated that patients might continue to be enrolled during the third quarter of 2011.
With minimal debt and a potentially lucrative pipeline to develop, OVIT could become an attractive speculative play. Any attention paid to this under-the-radar opportunity might quickly lead to a rise in share price, especially as the market cap continues to hover around ten million.
EPCT: Epicept now trades on the OTCBB with a share price still below the fifty cent mark. Still holding some long term potential based on a pipeline of multiple candidates, this one could still be a long term sleeper.
AMRN: Amarin is expected to file for FDA approval of AMR-101 in September. Positive results from two high profile trials launched this stock to near the twenty dollar mark early this year, and a positive review by the FDA is expected.
Partnership and/or buyout talk could return to add some speculative mojo to an Amarin investment, but it's still one to keep an eye on, regardless.
CELH: While still not announcing blow-away numbers for the second quarter, Celsius Holdings was able to maintain steady quarter-over-quarter sales for the first two quarters of the year in 2011. It's been a while since the company recorded back-to-back, steady and non-volatile quarters, and it could be a sign that consolidation into the retail sectors that work could be starting to pay off.
Still far from a turnaround story, there's evidence that Celsius could come back from the devastation that resulted from a failed marketing campaign and a push into retailers where the product didn't sell.
This stock is very lightly traded, and any significant attention with a positive tint could easily have it reaching the dollar mark again.
To note, however, financing is a concern, and investors that still might be hanging around are going to be looking for more significant quarter-over-quarter growth this time around.
SIGA: Still worth watching as the PIP trial looks to wind down.
GNBT: Share price not moving, but multiple positive updates and presentations have taken place on the pipeline front.
BDSI: Trending towards three, but long term potential remains.
Disclosure: Long AMPE, TTNP, CTSO, GERN, OVIT, BDSI, EPCT, CELH.
Stocks and Stories to watch this week: