Disc Medicine称与FDA就比托普汀的沟通仍具建设性——市场快讯

投资观察
Jan 14

Disc Medicine管理层在摩根大通医疗健康大会上的一场分析师活动中重申,其与美国食品药品监督管理局(FDA)就比托普汀(bitopertin)获批事宜的沟通依然富有成效。据BMO发布的一份报告指出,该公司正试图消除投资者因STAT News的一篇报道而产生的担忧,该报道称生物制品评价与研究中心主任Vinay Prasad对比托普汀的申请持怀疑态度。

分析师写道:“Disc Medicine的管理层特别(并再次)强调,与FDA的互动仍然是富有成效的,并且与公司和FDA审评人员频繁沟通的情况一致,其中并未提及Prasad就比托普汀提交申请所提出的任何所谓担忧。”分析师还补充道,BMO对Disc Medicine就该药物所做的商业化准备工作印象深刻。

(结束)道琼斯通讯社

2026年1月13日 14:16 ET(19:16 GMT)

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