一次情報の記録
重要申請受理
Boundless Bio: FDA、BBI-940キネシン分解薬のINDを受理
FDAは2026年1月にBBI-940のINDを受理し、ER+/HER2-およびTNBC-LAR乳がんを対象としたKOMODO-1初回ヒト試験の登録開始を可能にした。同社は、2028年後半までのキャッシュランウェイを有し、初期概念実証の結果発表をカバーする臨床プログラムを稼働させている。
主要事実
出典の抜粋
EX-99.1 2 bold-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Boundless Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Business Highlights KOMODO-1 first-in-human clinical trial of BBI-940 open for enrollment $108 million in cash provides runway into the second half of 2028, through expected clinical proof-of-concept readout for KOMODO-1 SAN DIEGO, March 09, 2026 – Boundless Bio (Nasdaq: BOLD) , a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced financial results and business highlights for the fiscal quarter and full year ended December 31, 2025. "With the KOMODO-1 trial of BBI-940 actively enrolling, we are excited