原始出處紀錄
重大臨床試驗登錄異動
Filana Therapeutics 解決 FDA 對 simufilam IND 的臨床暫停
該公司於 2025 年 12 月收到 FDA 的全面臨床暫停信函，目前正積極回應該機構對額外臨床前數據和方案修改的要求。公司計劃盡快提交對 FDA 的回應，並預計在未來幾個月內提供進度更新。
關鍵事實
- 申報時間
- 2026年3月12日 下午12:15
- 事件
- 臨床試驗登錄異動
- 方向
- 中性
- 來源
- SEC 8-K
- 可信度
- 有出處
來源摘錄
EX-99.1 2 exh_991.htm PRESS RELEASE EdgarFiling EXHIBIT 99.1 Filana Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results Working to advance TSC-related epilepsy program, with a focus on capital efficiency AUSTIN, Texas, March 12, 2026 (GLOBE NEWSWIRE) -- Filana Therapeutics, Inc. (formerly Cassava Sciences, Inc.) (NASDAQ: FLNA, “Filana Therapeutics”, the “Company”), a biotechnology company focused on developing novel medicines to modulate the filamin A protein for the treatment of central nervous system (CNS) disorders, such as Tuberous Sclerosis Complex (TSC)-related epilepsy, and other diseases associated with dysregulation or overexpression of filamin A, today reported financial results for the fourth quarter and year ended December 31, 2025, and provided a busines