VFC's Stock House has been monetarily compensated to cover IMUC and CYTR. The fact that VFC has been compensated inherently indicates a strong bias on my behalf. The goal of my website and all articles published on my behalf is to provide investors with information, opinions and starting points about various companies across many sectors. It's up to each individual investor to decide what he or she finds relevant.
Some companies in the biotech and pharmaceutical sectors making news this week:
APRI: Shortly after announcing that the FDA had granted clearance to Apricus Bio's wholly-owned subsidiary, NexMed USA, to market the anti-fungal cream Tolnaftate-D, marking the first such clearance for the NexAct drug delivery technology, Apricus followed-up this week with news that the FDA had granted a second over-the-counter clearance for a NexAct product, this time for the anti-itch drug, Hydrocortisone-D.
The back-to-back FDA clearances contributed to the APRI share price climbing above the four dollar mark again, after having dropped over the previous weeks as the market as a whole took a slide.
Apricus' game plan for growth includes initiating and then expanding its over-the-counter (OTC) product offerings, and the these two FDA clearances show that this strategy is beginning to take effect as a core of potential new revenue streams takes shape.
Also on the horizon for Apricus is the Canadian launch of the erectile dysfunction drug, Vitaros, which is expected to take place later this year. A commercial partner for that launch is expected to be announced over the near term, according to recent statements made by company officials.
Although back to trading for above four dollars, APRI could still experience some short term volatility, especially given that it doesn't look like the market has settled down too much.
DNDN: Shares of Dendreon have rebounded from their recent lows of below ten dollars, but the haircut experienced by the company earlier this month after revising the end-of-year sales guidance for Provenge has yet to set itself right again.
Although the sales guidance was shifted, developments have been panning out positive, with the company also receiving news that the Centers for Medicare and Medicaid Services (CMS) recently finalized its decision to grant full reimbursement for Provenge.
With production capability continuing to increase with the recent FDA facility approvals, and with demand for Provenge still growing, there's no reason to believe that this setback is just a temporary glitch on this company's way to fulfilling the 'Golden Age' expectations that the sector and investors have placed on Dendreon as the grand-daddy of cancer immunotherapies.
Given previous expectations and trends, along with the fact that Doctors will likely become more comfortable prescribing Provenge treatment knowing that full reimbursement is coming, it's likely, in my opinion, that the potential sales of Provenge during the next year will likely justify a return of the DNDN share price to previously-traded levels.
One thing is for certain, DNDN never fails at delivering some excitement.
Keep an eye on it as a rebound play.
IMUC: On the subject of Dendreon and Provenge, it's tough to leave Immunocellular Therapeutics (IMUC.ob) out of the conversation, as this company may be following in Dendreon's footsteps to become the leader of the next generation of cancer immunotherapy treatment.
Because Immunocellular views its technology as the next step in the realm of cancer immunotherapies, one should also consider the company as a perpetual candidate to either be bought out or land a major partnership.
IMUC's technology, from which lead candidate ICT-107 was devised for the treatment of glioblastoma (GBM), attacks the stem cells behind the growth and spreading of cancer. Maybe even more important than the step forward in the technology, however, may be the logistical advantages that the company has developed in production and manufacturing, which significantly reduces the costs associated with production.
Given that much of Dendreon's recent troubles stem from the high cost of Provenge treatment, IMUC's logistical advantage should be noted. Patients treated with ICT-107, for example, need to have their dendritic cells harvested only once, while those receiving Provenge need this process conducted three times during treatment, elevating the cost of treatment.
ICT-107 is still a Phase II product, but the development of this treatment and the technology should be monitored by investors of the sector, with DNDN being the example of what comes with a successful cancer immunotherapy stock.
GERN: Having fallen below the radar, the once high-flying Geron is still trading in the mid $2 range, where the company's arguable status as the leader of the stem-cell era remains in tact.
Mounting losses and a lack of investor attention contributed to GERN's slide, which coincided with the broad market sell-off, but the technology behind the company's previous success could also lead to its resurgence.
Geron's pipeline is full, with cancer trials in Phase II and its stem cell treatment for spinal cord injuries thus far successful in Phase I. The spinal cord trial was the first of its kind, when approved for initiation by the FDA.
It's my opinion that if ever there was a time to take a closer look at GERN, now's the time.
Geron's competitor company Advanced Cell Technology (ACTC) - competitor in the sense that it was the second to launch human trials with a stem cell therapy - has held up fairly well in the downturn, trading for just a couple of pennies from where it was before the market collapse started, and both could benefit by a market turnaround and increased speculative attention on the stem cell market.
Don't let Geron slip from the watch list.
CYTR: With seven clinical trials either under way or in the works, including bafetinib and tamibarotene already in multiple Phase II trials, CytRx is one to keep on the potential rebound list as the share price has dropped down to near thirty cents.
The pipeline is full, and until the recent market slide the positive updates were forthcoming on a regular basis as well, most concerning INNO-206, an experimental doxorubicin conjugate that targets cancerous tumors that was granted and orphan drug designation (ODD) for the treat treatment of soft tissue sarcomas from the FDA early last month.
Also of note, the company recently indicated that it might be looked to partner the development and commercialization of INNO-206, potentially CytRx's most lucrative product, based on its vast applications in the cancer treatment market.
Well worthy of a spot on the watch list.
SIGA: Siga shares spiked higher this week, after a recent return to sub-$5 prices, on news that the company landed a near-$8 million grant from the National Institutes of Health (NIH) for the development of antivirals to combat Lassa fever and other hemorrhagic fevers of Arenavirus origin.
SIGA's strategy of obtaining government money has paid off well, between the growing relationship with the NIH and with the recent contract award from BARDA, and although working with (or for) the US government doesn't come without its drama, companies that are "in," can usually stay "in" for quite some time, if not for their entire existence.
One drain on the SIGA share price at the current time - aside from the large short percentages noted this year - is the pending outcome of the PharmAthene (NYSEMKT:PIP) trial, where PIP claims that SIGA still owes them a cut of ST-246 due to an agreement that never fully materialized years ago.
Should the trial turn out in favor of SIGA, then a quick rebound in share price could result, but even if a settlement is in the works, the fact that this trial goes away serves as a bonus in itself.
The market drop didn't help SIGA any, as well, and it's another that could see a quick rebound if pending event pan out.
Disclosure: Long GERN, IMUC. VFC's Stock House is compensated to cover IMUC and CYTR for a period of 90 days.