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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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