Benzinga | Sep 22, 2021 07:01AM EDT

Fast Track Status Expanded For Inventiva's NASH Treatment

* The FDA has decided that the Fast Track designation previously granted to Inventiva SA's (NASDAQ:IVA) lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

* The decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August.

* Previously, the agency granted both Fast Track and Breakthrough Therapy designations to lanifibranor for NASH treatment in September 2019 and October 2020, respectively.

* The Company has initiated a NATiV3 Phase 3 trial evaluating lanifibranor in adult patients with non-cirrhotic NASH and F2/F3 stage of liver fibrosis.

* The patient screening started on September 8.

* Cash and cash equivalents stood at (euro)93.6 million as of June 30, 2021.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: IVA stock closed 0.36% lower at $13.93 on Tuesday.