IVA - Inventiva: Biotech To Consider Despite Short NASH Study Enrollment Pause

2024-02-22 16:50:41 ET

Summary

• Enrollment pause in phase III NATiV3 study, using lanifibranor for the treatment of patients with NASH, only expected to last 4 to 6 weeks; Trial to continue on with protocol amendments.
• Publication of results from phase IIa LEGEND study, using lanifibranor in combination with Jardiance for the treatment of patients with NASH and Type 2 Diabetes, expected Q1 of 2024.
• The global non-alcoholic steatohepatitis treatment market size is expected to reach $48.3 billion by the end of 2035.
• Several competitors in NASH, but the company might overcome most with the fact that oral administration can be given; Another option to beat the competition would be through combination treatments such as lanifibranor + Jardiance.

Inventiva S.A. ( IVA ) recently announced that enrollment had to be paused in the ongoing phase III NATiV3 trial, using its drug lanifibranor for the treatment of patients with non-alcoholic steatohepatitis [NASH]. The reason for the voluntarily pause of this late-stage study was because of one patients with a treatment-related serious adverse event [SAE]. This caused the stock price to trade significantly lower to $3.27 per share on February 16th of 2024. I believe that there might be a chance for recovery here with respect to this biotech for two reasons. The first reason is because this enrollment pause is just a short bump in the road. The Data Monitoring Committee [DMC] made the recommendation that this phase III NATiV3 study can continue to completion with several protocol amendments....

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