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Nov 2, 2026Quarterly update

Vertex raises 2026 revenue guidance, reports Crinetics deal close and povetacicept PDUFA date

Vertex lifted full-year revenue guidance to $13.15-$13.25 billion and said a decision on povetacicept in IgA nephropathy is due from the FDA on November 30, 2026.

Vertex Pharmaceuticals reported third quarter 2026 results on November 2, 2026, and raised its full year 2026 total revenue guidance to $13.15 billion to $13.25 billion from $13.1 billion to $13.2 billion previously.1 Total revenue for the quarter was $3.44 billion, up 12% compared to the third quarter of 2025, primarily driven by continued performance of cystic fibrosis therapies and growth from diversification into additional disease areas.1

On the regulatory front, the BLA submission for accelerated approval of povetacicept in IgA nephropathy is under priority review by the FDA, with a PDUFA target action date of November 30, 2026, supported by positive data from a pre-specified Week 36 interim analysis of the Phase 3 RAINIER trial.1 The company said if approved, povetacicept would become the first commercialized therapy in its emerging nephrology franchise.1

In cystic fibrosis, Vertex has initiated global regulatory submissions for ALYFTREK in children with CF ages 2 to 5 years.1 In sickle cell disease and transfusion-dependent beta thalassemia, the FDA approved CASGEVY in July for children 2 years of age and older, the first genetic therapy for these conditions cleared for patients that young,1 and in October the United Arab Emirates and Bahrain also approved the therapy for children 2 and older, while the U.K. approved it for children 5 and older.1

Pipeline timelines were reaffirmed across several programs: Vertex expects to complete enrollment in both Phase 3 studies of suzetrigine in diabetic peripheral neuropathy by the end of 2026, with results expected mid-2027,1 and it expects to share interim analysis data from the AMPLITUDE study of inaxaplin in APOL1-mediated kidney disease in early 2027.1

On capital, Vertex said cash, cash equivalents and total marketable securities fell to $9.8 billion as of September 30, 2026 from $12.3 billion at year-end 2025, reflecting roughly $9.0 billion in net cash spent on the Crinetics acquisition and share repurchases, partly offset by $4.5 billion drawn under a term loan executed in the quarter.1 The company said it completed the previously announced Crinetics Pharmaceuticals acquisition in September for approximately $10.0 billion in total equity value, or about $9.0 billion net of cash and marketable securities acquired.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.