Rein Therapeutics 收到 FDA 關於 LTI-03 臨床暫停的回饋

FDA 審查了補充的非臨床數據，確認 MCH/H 發現對 24 週 Phase 2 RENEW 方案在每日最高 10 mg 的劑量下並非劑量限制因素。公司獲建議提交 CRL 以解決安全性疑慮，無需進行新的 GLP 大鼠毒性研究；CRL 準備工作正在進行中，預計數週內提交。

關鍵事實

申報時間: 2025年9月22日下午12:00
事件: 臨床試驗登錄異動
方向: 中性
公司: RNTXRein Therapeutics
資產: LTI-03
來源: SEC 8-K
可信度: 有出處

來源摘錄

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