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335 articles about Zogenix, Inc.
Zogenix Announces FDA Acceptance for Filing of New Drug Application and Priority Review for FINTEPLA® for the Treatment of Dravet Syndrome
NDA supported by data from two pivotal Phase 3 trials in Dravet syndrome, both of which met the primary and all key secondary endpoints, and an interim analysis from an ongoing open-label extension study
Zogenix to Present at Two Investor Conferences in November
Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that Stephen J. Farr, Ph.D., President and CEO, and Michael P. Smith, Executive Vice President, CFO, Treasurer and Secretary, will participate in two investor conferences in November: Guggenheim Healthcare Talks Idea Forum Neuro/Immunology Day and Stifel 2019 Healthcare Conference.
Zogenix Provides Corporate Update and Reports Third Quarter 2019 Financial Results
Resubmitted NDA for FINTEPLA® for the treatment of Dravet syndrome
Zogenix to Release Third Quarter 2019 Financial Results and Host Conference Call and Webcast on November 7
Zogenix, Inc., a global pharmaceutical company developing rare disease therapies, announced that it will report its financial results for the three and nine months ended September 30, 2019, after the market close, and will host a corporate update conference call and webcast on Thursday, November 7, 2019, at 4:30 PM Eastern Time.
Clinical Catch-Up: October 21-25
10/28/2019Although the clinical trial news last week was dominated by the stunning reversal of Biogen and Eisai’s clinical trials of aducanumab for Alzheimer’s disease, there was plenty of other trial news. Here’s a look.
Zogenix Announces New Positive Data for Its Investigational Drug FINTEPLA® in Dravet Syndrome
Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced positive new data for its investigational drug, FINTEPLA® (ZX008, fenfluramine), for the treatment of seizures associated with Dravet syndrome
The new data could boost the company’s chances of securing regulatory approval.
Zogenix Announces Presentation of New Data for FINTEPLA® for the Treatment of Dravet Syndrome at the Child Neurology Society Annual Meeting
Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, announced that five posters related to its investigational therapy, FINTEPLA® (ZX008, fenfluramine oral solution), will be presented at the 48th Annual Meeting of the Child Neurology Society (CNS) being held in Charlotte, North Carolina, from October 23-26, 2019.
Clinical Catch-Up: October 7-11
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