Vertex PharmaceuticalsIn Development
Dual BAFF and APRIL inhibitor being studied for IgA nephropathy. Not approved. Vertex said that if the FDA approves it, the planned launch form is a low-volume subcutaneous autoinjector given at home every 4 weeks.
Latest update Oct 31, 2026
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The BLA has been accepted for accelerated approval in adults with IgA nephropathy. The Oct. 23, 2026 release restates the PDUFA target action date as November 30, 2026. Week 36 proteinuria results are in. The Week 104 eGFR-slope analysis has not been reported. The trial continues blinded until the last enrolled patient completes 104 weeks.
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Announced next steps from Vertex Pharmaceuticals that mention Povetacicept.
Nov 30, 2026
Await the FDA decision on povetacicept (from the Alpine acquisition) for IgA nephropathy after Phase 3 RAINIER showed a 52% reduction in proteinuria; the BLA was accepted under accelerated approval (using a priority review voucher to cut review time from ten months to six) with a PDUFA target action date of November 30, 2026. If approved, povetacicept becomes Vertex's first commercialized nephrology product.
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Vertex's flagship cystic fibrosis triple-combination CFTR modulator (elexacaftor/tezacaftor/ivacaftor), effective for roughly 90% of CF patients and the company's dominant revenue engine - now complemented by the once-daily next-generation Alyftrek.
A first-in-class oral, non-opioid pain medicine (VX-548) that selectively inhibits the NaV1.8 sodium channel to block pain signals in the peripheral nervous system before they reach the brain - the first new class of pain drug in over 20 years.
The first approved CRISPR/Cas9 gene-editing medicine (exagamglogene autotemcel), a one-time therapy for sickle cell disease and transfusion-dependent beta thalassemia, developed and commercialized with CRISPR Therapeutics.
An allogeneic, stem-cell-derived, fully differentiated islet cell therapy for type 1 diabetes designed to restore the body's own insulin production - a potential functional cure delivered as a one-time infusion.
An oral, once-daily somatostatin receptor agonist for acromegaly, acquired through the Crinetics Pharmaceuticals deal - Vertex's first marketed product outside CF, pain, and gene therapy, and the anchor of its new endocrine-disease business.
An oral pipeline candidate for endocrine disease acquired with Crinetics Pharmaceuticals, part of the endocrinology pipeline Vertex and Crinetics said could reach $5B+ in combined peak annual sales alongside Palsonify.
Once-daily next-generation CFTR modulator (vanzacaftor/tezacaftor/deutivacaftor). The Oct. 9, 2026 company release says the US indication is patients 6 years and older with a responsive CFTR variant. Use in children ages 2 to 5 is investigational.
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