Voyxact: Formal approval gains momentum with long-term eGFR improvement

研报英文原文证据摘录

Voyxact: Formal approval gains momentum with long-term eGFR improvement

Global Markets Research

2 July 2026Otsuka Holdings

4578.T 4578 JP / EQUITY: JAPAN PHARMACEUTICALS

Voyxact: Formal approval gains momentum with long-term RatingeGFR improvement Neutral

Target price JPY 11,000Quick Note

Closing price

1 July 2026 JPY 10,665Evidence of efficacy over two years provides strong momentum for official

approval: First impression somewhat positive (Note: Quick Note reports are not a

On 2 July, Otsuka Holdings announced topline results from the Phase 3 VISIONARY trial vehicle for changes to ratings, target

of Voyxact (NCT05248646), a treatment for IgA nephropathy. Detailed results will be prices, or earnings forecasts)

disclosed at a future conference, but the estimated glomerular filtration rate (eGFR, a

measure of the kidney's ability to filter waste products into urine) improved over two years.

This is positive, as these results significantly increase the likelihood that the drug will

transition from accelerated approval to full approval in the US. This would mean a

Research Analystscompetitive advantage in time to market compared with rival products.

Japan pharmaceuticals &Voyxact has first-mover advantage, but competitive threat remains unchanged healthcare

The topline result showed that the eGFR decline was within the normal expected range Hiroyuki Matsubara, Ph.D. - NSC

(less than 1mL/min/1.73m²/year). In other words, the average decline from baseline was hiroyuki.matsubara@nomura.com

estimated at -1.0 mL or better. While detailed results are unknown, we surmise this is +81 3 6703 1240

roughly equivalent to competing product atacicept from Vera Therapeutics, which showed

-0.6 ± 0.5mL at the 150mg dose over 96 weeks. Furthermore, in terms of average eGFR