FDA Approves Gilead's Seladelpar For Inflammatory Liver Disease, Acquired Via $4B CymaBay Deal
Portfolio Pulse from Vandana Singh
The FDA has granted accelerated approval for Gilead Sciences' (NASDAQ:GILD) drug Livdelzi (seladelpar) for treating primary biliary cholangitis (PBC). This approval follows Gilead's $4.3 billion acquisition of CymaBay Therapeutics. The approval is based on Phase 3 study data showing significant improvements in patients. However, continued approval is contingent on further clinical trials. Gilead's stock was down 0.04% in premarket trading.
August 15, 2024 | 1:09 pm
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Gilead Sciences received FDA accelerated approval for Livdelzi (seladelpar) for PBC, following its $4.3 billion acquisition of CymaBay Therapeutics. The approval is based on positive Phase 3 study results, but continued approval depends on further clinical trials. Gilead's stock was slightly down in premarket trading.
The FDA approval of Livdelzi is a significant milestone for Gilead, potentially boosting its product portfolio and revenue. However, the slight premarket decline suggests that investors may be cautious, possibly due to the need for further clinical trials to confirm long-term benefits.
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