- 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 €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.
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