Rein Therapeutics 收到 FDA 关于 LTI-03 临床暂停的反馈

FDA 已审阅补充的非临床数据，并确认 MCH/H 发现不会限制 24 周 2 期 RENEW 方案中最高 10 mg/天剂量的使用。公司被告知提交 CRL 以解决安全性问题，无需进行新的 GLP 大鼠毒性研究；CRL 准备工作正在进行中，预计在未来几周内提交。

关键事实

申报时间: 2025年9月22日 12:00
事件: 临床试验登记变更
方向: 中性
公司: RNTXRein Therapeutics
资产: LTI-03
来源: SEC 8-K
可信度: 有来源

来源摘录

8-K NASDAQ false 0001420565 0001420565 2025-09-16 2025-09-16 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of report (Date of earliest event reported): September 16, 2025 REIN THERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 001-38130 13-4196017 (State or Other Jurisdiction of Incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 12407 N. Mopac Expy. , Suite 250 , #390 Austin , Texas 78758 (Address of principal executive offices) (737) 802-1989 (Registrant’s telephone number, including area code) N/A (Former name or former address, if changed since last report) Check the appropriate box below

SEC 8-K