-- Euroz Hartleys週二發布的一份報告指出,Dimerix(ASX:DXB)有望受益於美國食品藥物管理局(FDA)近期批准Travere Therapeutics的sparsentan藥物用於治療局部節段性腎小球硬化症(FOSG),這是一種Dimerix也在研發的罕見腎臟疾病。 這家股票研究公司表示:“這一結果對Dimerix及其主要候選藥物DMX-200在監管審批和未來商業化方面都具有積極意義。” 報告指出,sparsentan是首個基於降低尿蛋白水平(即尿液中蛋白質含量)而獲得FDA全面批准的腎臟疾病藥物,這為將尿蛋白水平作為替代終點樹立了明確的先例。 Euroz Hartleys表示,這項進展顯著降低了FDA在DMX-200的傳統審批和加速審批中接受尿蛋白水平作為主要終點的風險,並凸顯了美國監管機構在FOSG方面具有的靈活性。 「從商業角度來看,Travere有望幫助建立局部節段性腎小球硬化症(FOSG)市場,提高公眾認知度、診斷率和醫療保險報銷率,從而加速DMX-200的推廣應用,」這家股票研究公司表示。 該公司補充道,Sparsentan和DMX-200是互補而非競爭關係,預計基於該疾病的進展特性和臨床醫生的回饋,這兩種藥物將在臨床實踐中同時使用。 Euroz Hartleys維持對Dimerix的投機性買入評級和1.65澳元的目標價。 該公司股價在周二的交易中上漲了11%。
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