一次情報の記録
重要試験登録の変更
Filana Therapeutics、simufilam INDに対するFDA臨床保留に対応
同社は2025年12月にFDAから完全な臨床保留通知を受け、追加の前臨床データおよびプロトコル修正に関する同庁の要請に積極的に対応しています。FDAへの回答は可能な限り速やかに提出される予定で、今後数ヶ月以内に進捗状況の更新が期待されています。
主要事実
出典の抜粋
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