ACTC: Shares of Advanced Cell Technology jumped 43% on Monday after the company announced that the FDA had given the green light to commence a trial measuring the safety and effectiveness of the company's embryonic stem cell treatment for severe vision loss.
Included with the significant rise in price was a volume surge that reached over a dozen times the normal trading average.
As I mentioned yesterday and according to public information, this trial is only the second of its kind approved for go-ahead by the FDA - the first being Geron's embryonic treatment for spinal cord injuries - and is a milestone for ACT in the sense that small, speculative company is validated along with with the big boys in a growing sector.
As with all developing biotech and small pharmaceutical companies, money will be an issue at some point, but ACT is primed to attract the interest of larger, deep-pocketed partners as the pipeline advances.
Judging by the impressive volume to open the new week, investor interest could be skyrocketing as well.
The noted trial is due to start early in 2011. With the company garnering more and more attention of late, it may be worth considering the accumulation shares for under a dime; just be aware of the risks of the volatile biotech and penny stock worlds, and keep in mind that financing will have to come from somewhere, and that could mean dilution will be a factor.
Disclosure: Long ACTC.
AVNR: Avanir Pharmaceuticals announced the completion of a public offering of common stock, a move intended to raise money for the upcoming commercial launch of Nuedexta. Nuedexta recently received FDA approval for the treatment of uncontrollable and spontaneous fits of laughing and crying.
After initially doubling in price, AVNR dropped to the current trading levels as fears of dilution and profit taking put a damper on what started out to be an impressive 'FDA approval' rally.
However, with the financing taken care of and the commercial launch of a new product pending, AVNR looks like a nice long term growth pick - one that should also be considered a possible takeover target in a time when large pharma is on the lookout for smaller companies who can boost pipelines for a relatively low price.
Twenty million shares of AVNR common stock were offered for a price of $4.40 a pop.
Disclosure: No position.
CVM: Cel-Sci Corp, a company preparing to launch a world wide head and neck cancer trial for its flagship immunotherapy product Multikine, announced on Monday that a "clinical investigator meeting" was held in the Czeck Republic last week discussing the upcoming trial.
According to a press release issued by the company, over 120 attendees from nine countries were present.
Multikine is slated to be a first line treatment for head and neck cancer, if the product makes it to market, and the upcoming Phase III trial is expected to be the largest ever conducted for this indication.
Cel-Sci has released a step-by-step synopsis for investors during the lead-up to a trial commencement, but the only news of concern at this point will be when the first patient is enrolled. No longer are we surprised or interested in the preparations, no more mac-n-cheese and jalepeno poppers - just bring the turkey, already.
There's no doubt that valid discussions regarding the upcoming trial took place in Prague, but it's hard not to imagine that Prague wasn't a nice perk that the board of Cel-Sci enjoyed on the investors' dime. After all, Prague is known for its history - and maybe most of all - its night life.
So the party time is over, boys, let's enroll a patient.
Disclosure: Long CVM.
