Vertex completes BLA submission for povetacicept in IgAN with priority review

VERTEX PHARMACEUTICALS INC / MA

Submitted rolling Biologics Licensing Application to FDA for povetacicept to treat IgAN in adults.
Used a priority review voucher, reducing expected FDA review to 6 months from typical 10 months.
Submission seeks potential accelerated approval; no decision or timeline for acceptance yet.
Company notes forward-looking statements and risks including regulatory approval uncertainty.

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