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FINWIRES

UniQure社、ハンチントン病治療薬の英国での販売承認申請を予定

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-- ユニキュア(QURE)は木曜日、ハンチントン病治療薬AMT-130について、第3四半期に英国での販売承認申請を行う予定であると発表した。 同社によると、申請の決定は、英国医薬品・医療製品規制庁(MHRA)との事前協議を経て行われた。 また、同社は第2四半期に米国食品医薬品局(FDA)とのタイプB協議の許可を得ており、第3四半期には第III相臨床試験の設計に関する主要な要素について協議し、解析計画に関するフィードバックを受ける予定であると述べた。 同社は、AMT-130の国際市場における承認取得に向けて、他の規制経路も積極的に模索しており、下半期にさらなる最新情報を提供する予定であると述べた。

Price: $19.02, Change: $+2.29, Percent Change: +13.66%

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