IPSEF - Genfit: Under The Radar Biotech With Upcoming Catalysts
2024-05-29 13:52:41 ET
Summary
- Genfit S.A. has a PDUFA date of June 10, 2024, by which time the FDA will decide upon whether elafibranor should be approved to treat patients with primary biliary cholangitis.
- European marketing approval of elafibranor for treatment of patients with primary biliary cholangitis is also possible; Expected to happen in 2nd half of 2024.
- Interim results from the phase 2 UNVEIL-IT study, using VS-01 for the treatment of patients with acute chronic liver failure, expected in the 2nd half of 2024.
- The global Acute on chronic liver failure market size is projected to reach $3.21 billion by 2030.
Genfit S.A. ( GNFT ) is gearing up for two regulatory decisions in the coming months. The FDA and European Medicines Agency [EMA] had both accepted regulatory filings of elafibranor for the treatment of patients with primary biliary cholangitis [PBC]. This creates two inflection points which are anticipated during this year. The first inflection point being a PDUFA date of June 10, 2024, by which the FDA will decide upon whether this drug should be approved to treat this patient population. The second inflection point, or catalyst, would be the EMA deciding upon regulatory approval as well. Such a decision is expected to happen in the 2nd half of 2024. The importance of such approvals is not only to get the drug to market, but that such approvals and commercial launches would trigger additional milestone payments from Ipsen (IPSEF)....
Genfit: Under The Radar Biotech With Upcoming Catalysts