US Food and Drug Administration

organization

Last mentioned: Mar 10, 2026

Timeline

  1. Potential Approval

    Estimated decision date if the FDA grants a 6-month priority review.

  2. FDA Filing Deadline

    Target date for completing the accelerated approval application with the FDA.

  3. Phase 3 Success

    Vertex reports povetacicept met primary goals in late-stage IgA nephropathy trial.

  4. Alpine Acquisition

    Vertex announces $4.9 billion acquisition of Alpine Immune Sciences to gain povetacicept.

Stories mentioning US Food and Drug Administration 1

market-trends Bullish

Vertex Shares Surge as Povetacicept Hits Phase 3 Goal in Kidney Disease

Vertex Pharmaceuticals reported that its lead kidney drug candidate, povetacicept, achieved a 52% reduction in proteinuria in a late-stage trial for IgA nephropathy. The success validates Vertex's $4.9 billion acquisition of Alpine Immune Sciences and marks a significant step in its strategy to diversify beyond cystic fibrosis.

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