Catatan sumber primer
MaterialPerubahan registri uji klinis
Filana Therapeutics mengatasi penahanan klinis FDA pada simufilam IND
Perusahaan menerima surat penahanan klinis penuh dari FDA pada Desember 2025 dan kini secara aktif menanggapi permintaan lembaga untuk data pra-klinis tambahan dan modifikasi protokol. Tanggapan kepada FDA direncanakan untuk diserahkan secepat mungkin, dengan pembaruan kemajuan diharapkan dalam beberapa bulan mendatang.
Fakta utama
- Diajukan
- 12 Mar 2026, 12.15
- Peristiwa
- Perubahan registri uji klinis
- Arah
- Netral
- Perusahaan
FLNAFilana Therapeutics- Aset
- simufilam
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
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
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Penting
7 Mei 2026
12.10
FLNAFilana TherapeuticsFilana Therapeutics memperbarui program simufilam TSC di tengah clinical hold FDA