09:59 AM EDT, 10/17/2025 (MT Newswires) -- Vertex Pharmaceuticals ( VRTX ) said Friday that the US Food and Drug Administration recently granted a rolling review of a biologics license application on povetacicept for the treatment of IgA nephropathy.
The company said it expects to submit povetacicept's first module to the FDA before the end of the year and complete a full biologics license application for accelerated approval in the US in H1 2026, depending on trial data.
Vertex also said it has started a phase 2b/3 trial of povetacicept as a treatment for primary membranous nephropathy.
Shares were up almost 1% in recent early trading.
Price: 412.35, Change: +3.74, Percent Change: +0.92