seladelpar
NDA- Indications
- Primary biliary cholangitis
Company intelligence / Profile preview
CymaBay’s lead asset seladelpar demonstrated statistically significant improvements over placebo in the pivotal Phase III RESPONSE trial for primary biliary cholangitis—including biochemical response rates and normalization of alkaline phosphatase at one year. Seladelpar also showed significant improvement in pruritus among patients with moderate-to-severe itch. The drug received FDA priority review status prior to the company’s acquisition by Gilead Sciences. Analysts expect it to become a therapy of choice for second-line treatment of PBC due to its efficacy profile and impact on quality-of-life symptoms like pruritus
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