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<p>Agios Pharmaceuticals（AGIO）宣布，FDA 尚未对用于治疗非输血依赖性和输血依赖性α或β地中海贫血成年患者的 mitapivat 的补充新药申请（sNDA）做出监管决定。该公司指出，sNDA 仍在积极审查中。FDA 发布的 PDUFA 目标日期为 2025 年 12 月 7 日。</p>
<p>Agios 表示，FDA 尚未提供其监管决定的时间表。该公司</p>
<p>继续与 FDA 合作，以完成对 sNDA 的审查。</p>
<p>Agios Pharmaceuticals 的股价在周一的盘前交易中下跌 2.6%，至 27.00 美元。</p>
<p>欲获取更多健康新闻，请访问 rttnews.com。</p>
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Agios制药

<p>Agios 制药的股票在盘前交易中下跌，原因是 FDA 尚未对 mitapivat 的补充新药申请做出决定。该 sNDA 仍在积极审查中，尚未提供监管决定的时间表。股价下跌 2.6%，至 27.00 美元</p>

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</div><p>Agios Pharmaceuticals (AGIO) announced that the FDA has not yet issued a regulatory decision on the supplemental New Drug Application for mitapivat for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The company noted that the sNDA remains under active review. The PDUFA goal date issued by the FDA was December 7, 2025.</p>
<div class="lb-trans"><p>Agios Pharmaceuticals（AGIO）宣布，FDA 尚未对用于治疗非输血依赖性和输血依赖性α或β地中海贫血成年患者的 mitapivat 的补充新药申请（sNDA）做出监管决定。该公司指出，sNDA 仍在积极审查中。FDA 发布的 PDUFA 目标日期为 2025 年 12 月 7 日。</p>
</div><p>Agios said the FDA has not provided a timeline for its regulatory decision. The company</p>
<div class="lb-trans"><p>Agios 表示，FDA 尚未提供其监管决定的时间表。该公司</p>
</div><p>continues to work with the FDA to conclude the review of the sNDA.</p>
<div class="lb-trans"><p>继续与 FDA 合作，以完成对 sNDA 的审查。</p>
</div><p>Shares of Agios Pharmaceuticals are down 2.6% to $27.00 in pre-market trade on Monday.</p>
<div class="lb-trans"><p>Agios Pharmaceuticals 的股价在周一的盘前交易中下跌 2.6%，至 27.00 美元。</p>
</div><p>For More Such Health News, visit rttnews.com.</p>
<div class="lb-trans"><p>欲获取更多健康新闻，请访问 rttnews.com。</p>
</div><p>For comments and feedback contact: editorial@rttnews.com</p>
<div class="lb-trans"><p>如有意见和反馈，请联系：editorial@rttnews.com</p>
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为什么 Agios 制药的股票在盘前交易中下跌？