1. EC conditionally authorizes GILD's seladelpar for PBC treatment with UDCA. 2. Seladelpar, an orphan designated product, targets patients failing UDCA therapy.
The conditional approval boosts GILD’s pipeline with a novel PBC treatment, similar to previous successful regulatory milestones that spurred investor optimism and revenue diversification.
The breakthrough approval enhances GILD’s competitive positioning in rare disease treatments, potentially leading to significant long-term revenue gains.
Approval paves the way for sustained market expansion and revenue growth, contingent on successful commercialization over time.