Roche reported interim Phase 3 success for sefaxersen, setting up a potential accelerated-approval path in a crowded kidney-disease market as competitors expand their chronic-care portfolios. The Swiss drugmaker’s update came as multiple branded therapies already hold approvals across segments of renal care. Separately, Vertex amplified the opportunity for its kidney candidate inaxaplin after positive Phase 2b data, strengthening the company’s case for broader label ambitions ahead of a pivotal readout next year. Vertex’s update underscores how urine-based efficacy endpoints and biomarker signals are increasingly used to shape late-stage regulatory strategy in kidney indications.
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