New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 3, 2013
07:36 EDTDRRX, ZGNXDurect announces positive results from Relday Phase 1 clinical trial
Durect (DRRX) announced that its licensee, Zogenix (ZGNX) reported positive single-dose pharmacokinetic results from the Phase 1 clinical trial of Relday, an investigational candidate of a proprietary, once-monthly subcutaneous formulation of risperidone for the treatment of schizophrenia. According to Zogenix, adverse events in the Phase 1 trial in patients diagnosed with schizophrenia were generally mild to moderate and consistent with other risperidone products.
News For DRRX;ZGNX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
May 27, 2015
08:44 EDTZGNXZogenix announces new efficacy data from study of low-dose fenfluramine
Zogenix announced new data demonstrating sustained efficacy and tolerability for patients treated with low-dose fenfluramine as an adjunctive therapy for Dravet syndrome. The data was authored by world-renown experts in the field of Dravet syndrome, Berten Ceulemans, M.D., Ph.D. and Lieven Lagae, M.D., Ph.D., from the Universities of Antwerp and Leuven in Belgium, and was presented at the European Paediatric Neurology Society meeting taking place this week in Vienna, Austria. Zogenix intends to initiate Phase 3 clinical studies for ZX008, the company's investigational proprietary pediatric formulation of low-dose fenfluramine, during the second half of 2015. ZX008 is designated as an orphan drug in both the U.S. and Europe for the treatment of Dravet syndrome. The results presented are from the latest 5-year follow-up period in a group of Dravet syndrome patients being treated with low-dose fenfluramine. This analysis, which includes ten patients from the original study group and two patients who began treatment in 2011, demonstrated that during any given year of the follow-up period, at least 80% of patients achieved a greater than or equal to 75% reduction in the frequency of seizures. In addition, three patients were seizure-free for all 5 years and five patients were seizure-free for 2 to 4 years. The use of low-dose fenfluramine in this group of patients was shown to be generally well tolerated, with the most common adverse events being transient loss of appetite and fatigue/somnolence. No clinically meaningful cardiac adverse events were noted. No patient discontinued treatment due to adverse events. In addition, a recently published translational research study to elucidate fenfluramine's mechanism of action in Dravet syndrome demonstrated the ability of fenfluramine to significantly reduce locomotion and eliminate epileptiform EEG activity in a gene knockdown zebrafish model of Dravet syndrome. These data support the clinical results obtained in the Belgium cohort of patients.
May 18, 2015
08:31 EDTDRRXDURECT announces positive results from DUR-928 Phase 1 study
DURECT announced that it has obtained positive results from a multi-dose Phase 1 clinical trial with an oral formulation of DUR-928, the lead molecule in DURECT's Epigenomic Regulator Program. DUR-928 is an endogenous, small-molecule, new chemical entity, which may have broad applicability in metabolic diseases such as nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. It may also play an important role in protecting against acute kidney injury and other types of acute organ injury. This Phase 1 trial was a single-site, randomized, double-blinded, placebo-controlled, multiple-ascending-dose study to evaluate the safety, tolerability, and pharmacokinetics of DUR-928 when orally administered once daily for 5 consecutive days to healthy volunteers. The 20-subject study evaluated DUR-928 in 2 consecutive 10-subject cohorts, the first receiving DUR-928 at a lower dose and the second at a higher dose. Following multiple dosing, DUR-928 was well-tolerated at both dose levels, with no clinically significant changes in vital signs, laboratory values or ECG parameters, no severe or serious drug-related adverse events reported and no subjects withdrawing from the study. Peak plasma concentrations achieved were at least 100-fold higher than endogenous levels, no accumulation in plasma concentrations were observed with repeat dosing, and dose related increases in plasma concentrations were observed with peak plasma concentration at approximately 2 6 hours after dosing.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use