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247 articles with Zogenix, Inc.
10/14/2019It was a busy week for clinical trial announcements. Here’s a look.
“This transaction advances Zogenix’s mission to become a leading rare disease pharmaceutical company by adding MT1621 to our pipeline of late-stage Fintepla programs,” stated Stephen J. Farr, president and chief executive officer of Zogenix.
There were two issues the agency had. First, the FDA wanted the inclusion of two animal studies to evaluate whether the drug caused thickening of the heart valve. The second was more of a goof—the contract research organization Zogenix employed uploaded the wrong data set for the application.
In April, the U.S. Food and Drug Administration (FDA) issued a Refuse to File (RTF) letter to Zogenix for its New Drug Application (NDA) for Fintepla (fenfluramine hydrochloride).
ZGNX DEADLINE ALERT: Rosen Law Firm Reminds Zogenix, Inc. Investors of Important June 11th Deadline in Securities Class Action -- ZGNX
Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of Zogenix, Inc.
SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in Zogenix, Inc. of Class Action Lawsuit and Upcoming Deadline- ZGNX
Pomerantz LLP announces that a class action lawsuit has been filed against Zogenix, Inc. and certain of its officers and directors.
ZGNX CLASS ACTION ALERT: Hagens Berman Alerts Zogenix (ZGNX) Investors to Securities Class Action, Encourages Investors to Contact the Firm
Hagens Berman Sobol Shapiro LLP alerts investors in Zogenix, Inc. to the securities class action pending in the United States District Court for the Northern District of California and to the June 11, 2019 Lead Plaintiff deadline.
Hagens Berman Alerts Zogenix (ZGNX) Investors of the Firm's Investigation of Possible Securities Law Violations, Encourages Investors to Contact the Firm
Hagens Berman Sobol Shapiro LLP alerts investors in Zogenix, Inc. to the firm's investigation of possible Federal securities law violations.
SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Zogenix, Inc. - ZGNX
Pomerantz LLP is investigating claims on behalf of investors of Zogenix, Inc..
Zogenix said the FDA determined that the NDA, which was submitted in February, was not “sufficiently complete to permit a substantive review.”
Supernus Pharmaceutical, headquartered in Rockville, Maryland, is acquiring Biscayne Neurotherapeutics, located in Miami, Florida.
Zogenix Phase 2 Study Results Published in Epilepsia Show ZX008 Provides Durable Reduction in Seizure Frequency in Patients With Lennox-Gastaut Syndrome
67% of Patients Achieved At Least a 50% Reduction in Convulsive Seizures
Zogenix announced positive top-line data from its second confirmatory Phase III clinical trial of ZX008 (low-dose fenfluramine hydrochloride) for children and young adults with Dravet syndrome.
Zogenix’s first global Phase 3 trial of ZX008, met the primary efficacy endpoint, as well as all prespecified key secondary efficacy endpoints.
Zogenix Announces New Positive Efficacy and Safety Data from Pivotal Phase III Clinical Trial of ZX008 in Dravet Syndrome
The updated Study 1 results, as well as additional data supporting the further investigation of ZX008 in refractory epilepsies, were presented at the 71st American Epilepsy Society Annual Meeting.
The Phase 3 multicenter, global LGS trial is divided in two parts.
Zogenix To Host Call With Pediatric Epilepsy Expert Joseph Sullivan, M.D., on Dravet Syndrome and ZX008 on Monday, December 4
The company will host an update call on Dravet syndrome and the Company’s investigational drug, ZX008, featuring pediatric epilepsy expert, Joseph Sullivan, M.D., on Monday, December 4, 2017, at 4:30pm Eastern Time.
New Data from Zogenix’s Phase III Trial of ZX008 in Dravet Syndrome (Study 1) and Findings on Disease Impact to be Presented at 71st American Epilepsy Society Annual Meeting
These posters will be presented at the 71st American Epilepsy Society (AES) Annual Meeting, which will take place at the Washington Convention Center in Washington, D.C., from December 1-5, 2017.
During the third quarter, the Company announced positive top-line results from its Phase 3 Study 1 of ZX008 in patients with Dravet syndrome.
Zogenix to Release Third Quarter 2017 Financial Results and Host Conference Call and Webcast on November 7
The company will host a corporate update conference call and webcast on Tuesday, November 7, 2017 at 4:30 PM ET.