Agios Pharmaceuticals Inc（纳斯达克代码：AGIO）宣布，针对其在研药物Mitapivat治疗镰状细胞病的研发计划，预计将于2026年第一季度与美国食品药品监督管理局（FDA）举行新药申请（NDA）提交前的会议。
此次Pre-NDA会议是药物审批流程中的关键一步，旨在就申请材料的完整性、数据呈现方式以及监管要求等关键问题进行沟通与对齐。Mitapivat作为一种口服的丙酮酸激酶激活剂，其在镰状细胞病这一遗传性血液疾病领域的开发进展备受市场关注。
公司此举标志着该药物研发进入了重要的后期阶段，为后续正式提交上市申请奠定基础。市场将密切关注此次会议的结果，因其可能对Agios未来的产品管线布局和商业前景产生重要影响。
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