-- Euroz Hartleys周二发布的一份报告指出,Dimerix(ASX:DXB)有望受益于美国食品药品监督管理局(FDA)近期批准Travere Therapeutics的sparsentan药物用于治疗局灶节段性肾小球硬化症(FOSG),这是一种Dimerix也在研发的罕见肾脏疾病。 这家股票研究公司表示:“这一结果对Dimerix及其主要候选药物DMX-200在监管审批和未来商业化方面都具有积极意义。” 报告指出,sparsentan是首个基于降低尿蛋白水平(即尿液中蛋白质含量)而获得FDA全面批准的肾脏疾病药物,这为将尿蛋白水平作为替代终点树立了明确的先例。Euroz Hartleys表示,这一进展显著降低了FDA在DMX-200的传统审批和加速审批中接受尿蛋白水平作为主要终点的风险,并凸显了美国监管机构在FOSG方面具有的灵活性。 “从商业角度来看,Travere有望帮助建立局灶节段性肾小球硬化症(FOSG)市场,提高公众认知度、诊断率和医保报销率,从而加速DMX-200的推广应用,”这家股票研究公司表示。 该公司补充道,Sparsentan和DMX-200是互补而非竞争关系,预计基于该疾病的进展特性和临床医生的反馈,这两种药物将在临床实践中同时使用。 Euroz Hartleys维持对Dimerix的投机性买入评级和1.65澳元的目标价。 该公司股价在周二的交易中上涨了11%。
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