-- テリックス・ファーマシューティカルズ（ASX:TLX）は金曜日、同社の神経膠腫画像診断薬候補TLX101-Pxの欧州における販売承認申請が受理され、210日間の積極的評価段階に入ったと発表した。 同社は声明の中で、現在の臨床診療ガイドラインを反映した幅広い臨床適応症を目指しており、210日目の審査で良好な結果が得られれば、間もなく各国での販売承認が得られる見込みだと述べた。 同社は、成人および小児において、進行性または再発性の神経膠腫と治療関連の変化を区別できる高度な画像診断への患者アクセスを拡大することを目指しており、将来的には追加の適応症の可能性もあるとしている。 声明によると、TLX101-Pxは、テリックス社の膠芽腫治療薬候補TLX101-Txの患者選択および治療効果判定ツールとしても開発されており、TLX101-Txは欧州および米国で希少疾病用医薬品指定を受けている。 再発性膠芽腫患者を対象としたTLX101-Txの第3相IPAX-BrIGHT試験が国際的に開始され、複数の欧州諸国で試験が開始される予定であると、同社は発表した。 テリックス・ファーマシューティカルズの株価は、直近の金曜日の取引で3%上昇した。
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