Stocks and stories for the coming week...
DNDN: Dendreon's earnings report, set for Wednesday, November 2nd, will be a key event for not just investors of the DNDN stock, but also for investors of the biotech/pharmaceutical sector as a whole.
The global market rebound last week was kind to Dendreon (DNDN), as shares closed Friday at over eleven dollars in anticipation of a quarterly earnings report set to hit during the coming week. Given the drastic revision of expected Provenge sales numbers during the last earnings call, investors are by no means looking for numbers in line with earlier company estimates that had Provenge sales approaching the $500 million mark for the year.
Another uptick, however, in positive sales momentum would have investors heavily interested again, judging by DNDN's quick rebound last week from its sub-$10 prices.
If Dendreon can prove that the issue of reimbursement is no longer much of a concern, then it's possible that this stock can continue its upward momentum to back towards $20. Even with the bad news of last quarter , Provenge sales still came in at over $50 million, offering a glimpse that Dendreon's true 'heyday ' is still underway.
HGSI: The ever-volatile shares of Human Genome Sciences (HGSI) closed last week on a downtick - or was it an uptick - after releasing an earnings report that demonstrated still-sluggish sales numbers for Benlysta, the company's lupus-fighting drug that is partnered with GlaxoSmithKline (GSK).
Shares had hit as high as fifteen dollars through the previous trading week on rumors that Glaxo might be lining up to acquire its smaller partner, although the price spike quickly subsided when nothing materialized from those rumors.
HGSI quickly dipped to below the ten dollar mark, although only briefly, after the earnings report, but closed Friday near the eleven dollar mark after some likely short covering and buying by those who don't believe that we've heard the last of the buyout talk.
Attention is increasing on this stock and company as the longs and shorts are starting to battle it out in the markets and on the message boards, much like the passionate investors of both Dendreon (DNDN) and SiriusXM (SIRI) do.
The rebound Friday will undoubtedly add fuel to the fire of the long argument that it's only a matter of time before a buyout offer for HGSI is announced, but expect continued volatility both to the long and short side as positions are consolidated and price guidances are adjusted.
SPPI: Spectrum Pharmaceuticals (SPPI) has been another big mover during the recent market rebound, with shares closer Friday at well over ten bucks on increased volume.
A full earnings report came out last week in a press release on Friday morning which offered a glimpse into what is being touted as 'record numbers' for the company, in terms on income and cash position.
In addition to the increasing cash position and sales numbers for its two lead products, Fusilev and Zevalin, another milestone is set for November as the FDA is due to rule on whether the bioscan requirement for Zevalin treatment will be lifted. The lifting of the bioscan requirement is expected to significantly increase the likelihood that doctors prescribe Zevalin, as the treatment will then be more convenient and less expensive for the doctor, patient and reimbursement process.
Spectrum continues to roll along with positive milestone events, and further share price increases are possible as pending developments unfold.
Keep an eye out for additional earnings details this week, but SPPI could continue to move higher on the higher revenue and solid cash position.
NVIV: As Geron (GERN) steals all the spotlight for the future treatment of spinal cord injuries (SCI), another company has preclinical data before the FDA and is looking to soon move invo human trials within the next couple of quarters.
InVivo's (INVO) biopolymer scaffold device (BSD) has proven effective in healing injured spinal cords in rats and non-human primates, with 100% of paralyzed monkeys able to walk again after treatment, and should the scaffold prove successful in human trials, then the scope of SCI treatment could be revolutionized.
A strategic partnership has been consummated between InVivo and the Miami Project in the search for a cure for paralysis and further trials testing the BSD with numerous drug and cell therapies are expected.
The technology behind this novel SCI treatment led to company co-founder Robert Langer, ScD, to be nominated for this year's Nobel Prize in medicine.
InVivo is awaiting the green light from the FDA to conduct human trials, and that green light could come at any time, making NVIV one to keep an eye on for the coming months. It's also worth noting that InVivo's BSD is being developed as a medical device, not as a new drug, meaning that the expected timeline to approval is drastically reduced when compared to new drug treatments.
TTNP: Since announcing the very significant news that the trial data compiled to date would be enough for Titan Pharmaceuticals (TTNP) to file for Probuphine approval with the FDA, shares have climbed on high volume to the $1.50 mark before stabilizing in that area to close last week.
Titan plans to outline the updated path to Probuphine approval in the coming weeks and is again a hot stock to watch, now that the FDA questions are resolved. Investors had speculated that the regulatory agency would request another trial or additional data before allowing Titan to proceed with the approval process.
Trading volume continued to sustain its increased rate to close the week and the more solid footing that the FDA/Probuphine news gives the company, it's likely that some takeover talk will be reinvigorated.
Given the current trading price, if TTNP were to be taken out, the $2.50-$3.00 range would be a likely expectation, although Titan's ProNeura drug delivery technology and additional application of Probuphine for the treatment of chronic pain provide Titan with more value over the long term.
One to watch again.
KERX: Shares of Keryx Biopharmaceuticals (KERX) have done a good job at rebounding from the lows seen the past few weeks that resulted over questions about the success of the ongoing Phase III Perifisone trial. Friday's close saw shares up another seven percent, with another inch higher achieved during after-hours trading.
Both Perifisone and Zerenex trial results are expected early next year, making Keryx a company with enough milestone news pending to be a hot story for the coming months. The results of these trials will determine this company's viability as an investment and/or a stand-alone entity, with respect given to some increased buyout speculation.
MNKD: Mannkind (MNKD) will be reporting quarterly earnings on November 3rd, as shares continue to hover right around the three dollar mark. Some MNKD options activity to close last week hinted at some pre-earnings interest in this company, but nothing out of the ordinary is expected of Mannkind as it continues to develop its inhaled insulin, Afrezza, for market.
The FDA asked for an additional trial earlier this year, and that has dominated the headlines for the company.
It's usually around earnings time that buyout and partnership talk starts to emulate around Mannkind, but I wouldn't expect anything more than updates on the new trial and new timelines for the approval process.
Another earnings play to watch.
CCLR: Ever sit up at night wondering why there's not more Hooters in the world? It might be time to keep an eye on Chanticleer Holdings, Inc., as this holding company is quickly making an international play to bring more Hooters restaraunts to the quickly-growing emerging markets of the world.
In the past couple of months, Chanticleer announced the opening of its fourth Hooters restaraunt in South Africa as well as the opening of a location in Australia's capital city.
Chanticleer, as a holding company, also owns a successful portfolio of value-based investments and, along with its partners, is the largest Hooters franchisee in the U.S. and owns more than 450 restaurants in 44 states and 28 foreign countries.
With Hooters being one of America's finest brands, keep an eye on the international growth being established and expanded by Chanticleer.
SIRI: It didn't take long for SIRI to rebound from its dip to the $1.30s, having closed last week above $1.80. SiriusXM (SIRI) is another earnings play for the upcoming week, and as usual the fervent longs and shorts of the stock are gearing up and taking their positions.
The launch of the next generation of SiriusXM receivers and services and some recent announcements by used car dealers to offer a free trial of the satrad service have investors excited again, and SIRI is going to be a stock to watch leading into the company's earnings report this week.
As usual, this stock offers numerous trading opportunities , but also retains a loyal 'Buy & Hold' following.
ACTC: Shares of Advanced Cell Technology (ACTC) quickly dropped to below the ten cent mark last week following the announcement of a lawsuit revolving around shares and warrants, but a late-week turnaround had ACTC up over twelve cents again.
Still a recognized leader in embryonic stem cell research and treatment, the recent slide might be a good time to take a closer look at this company. Although still a long way from bringing its stem cell technology to market, ACT is developing treatments in very lucrative markets and always attracts a solid following when embryonic stem cell research headlines the news reports.
With the lawsuit adding increased volatility to this stock, keep an eye on the moves, as opportunities to trade and/or accumulate for the future are sure to materialize.
CLDX: Nice rebound to over three bucks that materialized quickly. Still worth watching, given the potential of its developing cancer immunotherapy treatments.
CTSO: Did not enjoy a price rebound along with the rest of the market, but this company's blood purifying technology should not be ignored. Although approved in Europe for the treatment of conditions with high cytokines in the blood, investors stateside may be skeptical about the length of time needed for a US approval, even with the relatively quick time frame for approvals of medical devices.
CELH: Celsius Holdings is starting to look like it has a pulse again, although the true measure of any potential rebound will be told in the next quarterly report. Given the consistency in the last two earnings announcements, it's likely that the next report could show Celsius bringing in revenue worth more than half of the company's current market cap. Concerns over financing may be weighing down the optimism.
CPST: The next earnings report for Capstone is still over a week away, but investors will be anxiously awaiting evidence that this company is making continued strides towards profitability. A growing domestic and international presence has had Capstone in the news all year for the potential of its green, low-emission microturbine units.
Enjoy the trading week, and the earnings season...and Happy Halloween!!!
Disclosure: Long DNDN, HGSI, NVIV, TTNP, KERX, MNKD, CELH, CTSO, CPST, ACTC.