ZGNX

ZX008

Lennox-Gastaut syndrome

sNDA Submission (Meeting with FDA)

Exp Date

September 2020

Amp Volatility Score

39%

Catalyst Info & Data Links

TITLE: ZX008 in Lennox-Gastaut syndrome - sNDA Submission (Meeting with FDA)

  • ClinicalTrial.gov (NCT03355209): A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome


  • ClinicalTrial.gov (NCT03936777): A Study to Investigate the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution in Children and Adults With Epileptic Encephalopathy Including Dravet Syndrome and Lennox-Gastaut Syndrome


WHAT IS THE CATALYST EVENT?


WHEN WILL THE EVENT (OR DID THE EVENT) OCCUR?

  • September 20202


PRIOR DATA/EVENTS


PRESS RELEASES

COMPETITORS

MARKET

MECHANISM OF ACTION / RATIONALE

  • Fenfluramine's antiepileptic activity is thought to arise from agonist activity of neuronally released serotonin (5‐HT) or via a direct agonist effect on 5‐HT receptors (5HT1D and 5HT2C). Additionally, fenfluramine has been shown to have effects on sigma 1 receptors, which have been implicated as having a role in epilepsy (Lagae et al., 2018). 

Updated by HC

#ZGNX, #ZX008, #Lennox-Gastaut_syndrome, #sNDA

Prior Data (click to view full image)

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Trial Design / Revenue (click to view full image)

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