Operator
Ladies and gentlemen, welcome to the Newron Update Call. I am Sandra, the Chorus Call operator. [Operator Instructions] The conference is being recorded. The conference must not be recorded for publication or broadcast. At this time, it is my pleasure to hand over to Stefan Weber, CEO. Please go ahead, sir.
Stefan Weber
CEO & Executive Director
Thank you, Sandra, and thank you to everyone joining us today. I’m on this call with Ravi Anand, our Chief Medical Officer, who right now is in Tokyo, Japan. We appreciate the opportunity to speak with you directly about evenamide and ENIGMA-TRS Phase III program.
We have received, as you read this morning, the FDA’s written communication regarding the clinical hold at the U.S. study centers in the ENIGMA-TRS 2 Study. Our team is reviewing the agency’s feedback. And today, I want to share where that work stands and update you on the ENIGMA-TRS program. Let me start with saying that Newron has extensive experience in sodium channel pharmacology, including the development of Xadago, an approved product with sodium channel blocking activity on the market in Europe for 11 years and 9 years in the United States.
We are right now mostly focused on developing evenamide for people living with treatment-resistant schizophrenia and poorly responding patients with schizophrenia. The therapeutic options remain extremely limited. We believe that evenamide’s novel mechanism has the potential
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