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Vertex Pharmaceuticals kidney disease drug trial successful, stock price soars 6%
Investing.com – Vertex Pharmaceuticals (NASDAQ:VRTX) stock rose 6% pre-market on Thursday to $488.52 after the company announced successful late-stage trial results for its kidney disease drug and plans to seek U.S. regulatory approval.
The drug povetacicept is being developed to treat IgA nephropathy, reducing key markers of kidney damage by 52% after 36 weeks, compared to only a 4.3% decrease in the placebo group. The study met its primary interim endpoint, with a 49.8% reduction in proteinuria after placebo adjustment.
Vertex said it will seek U.S. approval for povetacicept based on the results of the Phase 3 RAINIER trial involving 199 patients. At 36 weeks, 42% of patients taking povetacicept achieved the KDIGO target proteinuria level (less than 0.5g/d), compared to only 6% in the placebo group.
The trial showed a higher incidence of upper respiratory tract infections in the povetacicept group at 18.3%, versus 11.4% in the placebo group. Vertex noted that the drug is being studied in a more challenging patient population, with longer disease duration and higher use of SGLT2 inhibitors.
Wall Street analysts had mixed reactions to these results. Barclays analyst said, “While many expected positive data, we believe the magnitude of UPCR reduction (about 50% after placebo adjustment) is at the high end of investor expectations. Overall, the data and cross-trial comparisons suggest this drug has best-in-class efficacy.”
However, Baird analyst commented, “The Phase 3 RAINIER results for povetacicept in IgAN drove some gains in after-hours trading, but we still believe this optimism is misplaced, as the UPCR reduction is nearly identical to Otsuka’s (OTSKY, not covered) approved APRIL inhibitor Voyxact. With Otsuka leading and povetacicept showing no significant differentiation, we continue to think the hype around this project as Vertex’s next major growth driver is overblown, given that similar first-in-class and best-in-class drugs are already on the market.”
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