原始出處紀錄
重大臨床試驗登錄異動
Cassava Sciences：FDA 對 simufilam TSC 癲癇試驗發出全面臨床暫停令
FDA 發出正式函件，對 simufilam 用於 TSC 相關癲癇的擬議概念驗證試驗發出全面臨床暫停令。該暫停令要求提供額外的臨床前數據並修改試驗方案。Cassava 不再預期在 2026 年上半年啟動該試驗。
關鍵事實
- 申報時間
- 2025年12月18日 下午10:02
- 事件
- 臨床試驗登錄異動
- 方向
- 負面
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
sava20251218_8k.htm false 0001069530 0001069530 2025-12-15 2025-12-15 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 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) December 15, 2025 Cassava Sciences, Inc. (Exact name of registrant as specified in its charter) Delaware 001-41905 91-1911336 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification Number) 6801 N Capital of Texas Highway, Building 1; Suite 300 Austin , Texas 78731 (Address of principal executive offices, including zip code) ( 512 ) 501-2444 (Registrant ’ s telephone number, including area code) (Former name or former address, if chan