Vertex's Inaxaplin Shows Strong Proteinuria Reduction in Phase 2b, Pivotal Trial Fully Enrolled
VRTX sits 36% above its 52-week low of $374.17.
Summary
Vertex reported positive Phase 2b AMPLIFIED results for inaxaplin in APOL1-mediated kidney disease (AMKD). In the modest proteinuria cohort, inaxaplin reduced UACR by 42.7% and UPCR by 44.7% at Week 13, consistent with prior Phase 2a data. The type 2 diabetes cohort showed a smaller but still meaningful reduction (UACR -17.3%, UPCR -25.4%). Safety was clean with no related serious adverse events, though mild transient transaminase increases occurred in ~13% of participants; shares rose ~2.4%. Enrollment is now complete in the pivotal Phase 2/3 AMPLITUDE trial, with interim analysis data expected in early 2027. If positive, that data could support accelerated approval in the U.S. This expands the evidence base for inaxaplin as a potential first-in-class therapy for AMKD, a disease with no approved treatments affecting ~150,000 people in the U.S. and Europe.
Updated with a Wiseek News report · What changed
Updates
· Wiseek News — Mild transient transaminase increases occurred in ~13% of participants; shares rose ~2.4%.
· Benzinga — William Blair reiterated Outperform, calling the drug underappreciated; stock rose 2%.
At the time of this announcement, VRTX was trading at $510.72 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $129.4B. The 52-week trading range was $374.17 to $560.25. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: BusinessWire.