一次情報の記録
決定級諮問委員会の日程決定
Cabaletta Bio: 筋炎におけるrese-celのFDA整合登録コホート
Type Cミーティングで、RESET-Myositis試験内のDM/ASySを対象とした14例単群登録コホートについてFDA整合を達成。主要評価項目は、免疫調節薬中止かつステロイド無投与または低用量投与下での16週時点の中等度または高度TIS奏効。登録コホートは2025年4Qに開始予定で、BLA提出は2027年を計画。
主要事実
出典の抜粋
EX-99.1 2 caba-ex99_1.htm EX-99.1 Corporate Presentation October 2025 Disclaimer This presentation, including any printed or electronic copy of these slides, the talks given by the presenters, the information communicated during any delivery of the presentation and any question and answer session and any document distributed at or in connection with the presentation (collectively, the “Presentation”) has been prepared by Cabaletta Bio, Inc. (“we,” “us,” “our,” “Cabaletta” or the “Company”) and may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to our business, operations, and financial conditions, and include, but are not limited to, express or implied statements regarding our current beliefs, expectations and assu