Here are some Bio Pharma stocks with possible catalysts factors to watch today, Wednesday June 13, 2012. Catalyst trades in the bio-pharma sector can provide big profits if traded correctly. Some traders and investors who enjoy bringing more risk into play often times will hold through the catalyst event. While this does bring a lot more risk into play, the reward from engaging in this can be a massive one.
Genzyme has submitted applications to the U.S. Food and Drug Administration and European Medicines Agency for the approval of its multiple sclerosis drug Lemtrada. The submission included two Phase III studies of the drug.
The drug candidate was a key bargaining chip in the Cambridge, Mass.-based company's acquisition negotiations with its new parent, French drug maker Sanofi (NYSE:SNY), leading up to the deal announcement in February 2011.
The potential MS therapy is already approved to treat leukemia under the name Campath, and Genzyme executives called results from a second Phase III trial for Lemtrada, released earlier this year, "unprecedented."
The data showed that in a study with over 600 patients who had previously been treated with other drugs, there was a 49 percent reduction in the annualized relapse rate, versus Rebif, made by Rockland, Mass.-based EMD Serono.
"There remains a large unmet treatment need for patients living with active disease and we believe that Lemtrada, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS," Genzyme CEO David Meeker said in a statement.
Approximately 95 percent of the patients stayed in the trial until the end. Three patients died, but two of those were in motor vehicle accidents, and the other Genzyme attributed to disability associated with a relapse from before the patient joined the trial.
Regenicin, Inc. (OTCPK:RGIN) a biotechnology company specializing in the development of and commercialization of regenerative cell therapies to restore the health of damaged tissues and organs, announced yesterday that the FDA has granted Orphan Status for the PermaDerm® product, the only tissue-engineered skin prepared from autologous (patient's own) skin cells consisting of both epidermal and dermal layers, that is indicated for catastrophic burn patients.
Over 4 million shares of the stock traded within a couple of hours, compared to a daily average of 136K after the company's tissue replacement therapy, which creates a substitute skin to treat catastrophic burn victims using the patients' own skin cells finally received the orphan product designation which investors had been waiting for.
Investors please take note: The FDA has not approved this treatment, but has simply granted orphan drug status.
Arena Pharma (NASDAQ:ARNA) closed yesterday at $7.88, and as of 9:36AM ET today was trading at $8.19. Anticipation is mounting on an approval of its weight loss drug, Lorcaserin receiving approval before its actual PDFUA of June 27th, 2012.
Lorcaserin, an investigational drug candidate intended for weight management, is a new chemical entity that is believed to act as a selective serotonin 2C receptor agonist. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area believed to be involved in the control of appetite and metabolism. Arena has patents that cover Lorcaserin in the United States, Europe and other jurisdictions that in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity Arena might obtain.
Vivus' (NASDAQ:VVUS) own weight loss drug candidate Qnexa, is set to have its NDA review by the FDA by July 17th, 2012.
Qnexa is an investigational drug candidate being developed to address weight loss, type-2 diabetes and obstructive sleep apnea. The drug is a once-a-day, proprietary, oral, controlled-release formulation of low-dose phentermine and topiramate, which is designed to decrease appetite and increase satiety (the sense of feeling full), the two main mechanisms that impact eating behavior.
Qnexa has completed Phase III clinical trials for obesity, and Phase II trials for diabetes and obstructive sleep apnea. After the initial red-light from the FDA advisory committee in 2010, the pending FDA decision on July 17th, 2012 could determine the longer term future of Qnexa.
Alkermes (NASDAQ:ALKS) announced Tuesday that Janssen Research & Development, LLC has initiated a phase 3 clinical research program for a three-month formulation of INVEGA® SUSTENNA® (paliperidone palmitate), an injectable medicine for the treatment of schizophrenia.
Two phase 3 studies are expected to enroll approximately 1,800 patients with schizophrenia and will assess the efficacy, safety and tolerability of the three-month injectable formulation. Results are expected from these studies in 2014.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
DISCLAIMER: This article is intended for informational and entertainment use only and should not be construed as professional investment advice, but rather my opinions as a writer only. Always do you own complete due diligence before buying and selling any stock.