原始来源记录
重大其他
Lexeo：FDA 同意汇总 I/II 期数据用于 LX2006 加速批准
FDA 同意评估将正在进行的 I/II 期研究中的 LVMI 数据与新的关键研究数据汇总后提交的 BLA，并同意在早于 12 个月的时间点评估 LVMI 共同主要终点。Lexeo 将在启动关键试验前提交增强的制造可比性数据，并满足一项额外的非临床要求。期中数据显示，基线 LVMI 异常的受试者在 6 个月时平均 LVMI 降低 18%，12 个月时降低 23%，均超过 10% 的阈值。
关键事实
来源摘录
EX-99.1 2 lxeo-ex99_1.htm EX-99.1 Lexeo Therapeutics Announces Progress in FDA Discussions for Accelerated Approval Pathway and Positive Interim Clinical Data for LX2006 in FA CardiomyopathyOctober 7, 2025 Exhibit 99.1 Forward Looking Statements This presentation contains “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, statements regarding Lexeo’s expectations and plans regarding its current product candidates and programs, including statements regarding the structure of and timelines for completion of any current or additional clinical trials required by the FDA, the timing for receipt and announcement of data from any such clinical trials, and the timing and likelihood of potential regulatory developments, trial design chan