VRTX · News · 20260922N

Product / Drug Pipeline Progress

VERTEX PHARMACEUTICALS INC / MA · 2026-09-22 · Importance 31 · Surprise 42 · In source text

Vertex reported positive Phase 2b AMPLIFIED results for inaxaplin in APOL1-mediated kidney disease (AMKD), including a 42.7% reduction in urine albumin-to-creatinine ratio among patients with modest proteinuria and a 17.3% reduction among patients with type 2 diabetes. Inaxaplin was evaluated at a 45 mg once-daily dose on top of optimized standard of care, and reported adverse events were generally mild or moderate. Vertex completed enrollment in the pivotal Phase 2/3 AMPLITUDE trial, with interim data expected in early 2027 that could support accelerated U.S. approval. The AMPLIFIED findings may expand the addressable population by approximately 100,000 patients in the U.S. and Europe beyond the current pivotal-trial population.

Key facts

• Fierce Biotech reported Vertex plans to discuss the Phase 2b results with regulators and expects interim data from its pivotal Amplitude trial early next year, which could lead to accelerated FDA approval. source
• In the AMPLIFIED study, urine albumin to creatinine ratio (UACR) fell 42.7% in patients with modest proteinuria. source
• Vertex said interim AMPLITUDE trial results could lead to accelerated approval in the U.S. source
• Vertex expects interim analysis results from the Phase 2/3 AMPLITUDE trial in early 2027. source
• In the AMPLIFIED study, UACR fell 17.3% in patients with APOL1-mediated kidney disease and type 2 diabetes. source
• Vertex has completed enrollment for its pivotal Phase 2/3 AMPLITUDE trial. source
• Investing.com and other outlets reported Vertex plans to release interim AMPLITUDE trial data in early 2027 which could support accelerated approval in the U.S. source
• Fierce Biotech reported the new Phase 2b findings could potentially add 100,000 patients in the U.S. and Europe to Vertex's target population for inaxaplin. source

Impact estimates