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<p>Agios Pharmaceuticals（AGIO）宣佈，FDA 尚未對用於治療非輸血依賴性和輸血依賴性α或β地中海貧血成年患者的 mitapivat 的補充新藥申請（sNDA）做出監管決定。該公司指出，sNDA 仍在積極審查中。FDA 發佈的 PDUFA 目標日期為 2025 年 12 月 7 日。</p>
<p>Agios 表示，FDA 尚未提供其監管決定的時間表。該公司</p>
<p>繼續與 FDA 合作，以完成對 sNDA 的審查。</p>
<p>Agios Pharmaceuticals 的股價在週一的盤前交易中下跌 2.6%，至 27.00 美元。</p>
<p>欲獲取更多健康新聞，請訪問 rttnews.com。</p>
<p>如有意見和反饋，請聯繫：editorial@rttnews.com</p>
<p>商業新聞</p>

Agios制藥

<p>Agios 製藥的股票在盤前交易中下跌，原因是 FDA 尚未對 mitapivat 的補充新藥申請做出決定。該 sNDA 仍在積極審查中，尚未提供監管決定的時間表。股價下跌 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）宣佈，FDA 尚未對用於治療非輸血依賴性和輸血依賴性α或β地中海貧血成年患者的 mitapivat 的補充新藥申請（sNDA）做出監管決定。該公司指出，sNDA 仍在積極審查中。FDA 發佈的 PDUFA 目標日期為 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 尚未提供其監管決定的時間表。該公司</p>
</div><p>continues to work with the FDA to conclude the review of the sNDA.</p>
<div class="lb-trans"><p>繼續與 FDA 合作，以完成對 sNDA 的審查。</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 的股價在週一的盤前交易中下跌 2.6%，至 27.00 美元。</p>
</div><p>For More Such Health News, visit rttnews.com.</p>
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<div class="lb-trans"><p>如有意見和反饋，請聯繫：editorial@rttnews.com</p>
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為什麼 Agios 製藥的股票在盤前交易中下跌？