|Healthcare Review: Pluristem Therapeutics, Vanda Pharmaceuticals, VIVUS, Protalix BioTherapeutics, Keryx Biopharmaceuticals|
|By Staff and Wire Reports|
|Wednesday, 19 June 2013 14:47|
Pluristem Therapeutics Inc. (NASDAQ:PSTI) stock is trading at $2.79. The company on June 19 provided an update on the status of its clinical trials in Intermittent Claudication (IC). As previously announced, on June 4, 2013 the company received notification from the U.S. Food & Drug Administration (FDA) that its U.S. phase II IC trial was put on hold following the hospitalization of a patient with an allergic reaction in the company's IC trial in the United States.
Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) shares dropped 18.96% to $8.86. The company on June 17 presented additional data at ENDO 2013, the Endocrine Society's 95(th) Annual Meeting, demonstrating that tasimelteon can entrain (synchronize) both melatonin and cortisol rhythms. This effect further confirms tasimelteon's potential to reset the master body clock and address the circadian desynchrony which is inherent in Non-24-Hour Disorder (Non-24).
The SET (Safety and Efficacy of Tasimelteon) and RESET (Randomized-withdrawal study of the Efficacy and Safety of Tasimelteon to treat Non-24-Hour Disorder) Phase III studies were designed to assess the safety, efficacy and maintenance effect of tasimelteon for Non-24. Currently there is no approved FDA treatment for Non-24.
VIVUS, Inc. (NASDAQ:VVUS) shares gained 1.09% to $13.91. The company on June 19 announced positive results from a multicenter, placebo-controlled study, TA-501, designed to assess the efficacy of STENDRA™ (avanafil) in approximately 15 minutes. In the study, STENDRA patients achieved statistically significant improvement over placebo, in the mean proportion of attempts that resulted in erections sufficient for successful intercourse, as early as 10 minutes for the 200 mg dose and 12 minutes for the 100 mg dose after being taken.
Protalix BioTherapeutics Inc. (NYSEMKT:PLX) shares gained 2.17% to $5.19 in the morning hour. The company on June 19 announced that it has entered into a supply and technology transfer agreement with Fundação Oswaldo Cruz (commonly referred to as Fiocruz), an arm of the Brazilian Ministry of Health for UPLYSO™ (alfataliglicerase), the Company's proprietary enzyme replacement therapy for the treatment of Gaucher disease. Gaucher disease is a rare lysosomal storage disorder that affects approximately 10,000 people worldwide.
Keryx Biopharmaceuticals (NASDAQ:KERX) shares gained 8.73% to $8.33. J.P. Morgan analyst Cory Kasimov initiated coverage on Keryx Biopharmaceuticals on June 19 with a rating of Overweight and a price target of $13.
Additionally, the company on June 3 announced the presentation of updated efficacy and safety data from the Phase 3 long-term clinical trial of Zerenex (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis.