在第三期试验中,Zenas BioPharma的奥贝克西利马布在IgG4相关疾病爆发率降低了56%,达到主要终点.
Zenas BioPharma's obexelimab reduced IgG4-related disease flares by 56% in Phase 3 trial, meeting its primary endpoint.
Zenas BioPharma, INDIGO第3阶段对IgG4相关疾病的Obexelimab试验达到了其主要终点,显示在52周内比安慰剂减少了56%的疾病照明风险,所有二级终点都有显著改善,安全情况良好。
Zenas BioPharma's Phase 3 INDIGO trial of obexelimab for IgG4-related disease met its primary endpoint, showing a 56% reduction in disease flare risk over 52 weeks versus placebo, with significant improvements across all secondary endpoints and a favorable safety profile.
该公司计划在今年晚些时候在Q2 2026申请美国批准,并提交欧洲批准。
The company plans to file for U.S. approval in Q2 2026 and for European approval later in the year.
尽管取得了积极的成果,但由于结果没有达到华尔街的预期,特别是安根的乌普利兹纳(Uplizna)显示照明弹减少了87%,因此股票下跌了55%以上。
Despite the positive results, shares dropped over 55% as the outcome fell short of Wall Street expectations, particularly compared to Amgen’s Uplizna, which showed an 87% reduction in flares.