Prioritizing relapsed/refractory AML, with a goal of submitting an approval application between 2026 and 2028
First written in FY2024. 2 of 4 entries say "Softened", first in FY2025. Latest entry: 2026-10-15.
No other company in this theme has enough history to compare yet.
- FY2025SoftenedAnnual report
「We have formulated our plan to file for approval in the latter part of 2028 under the current clinical trial strategy on the assumption that the designation programs described above in Japan and overseas can be used.」
The approval filing target was specified as the latter part of 2028, later than the previous target of between 2026 and 2028. It was also stated that the plan assumes the use of designation programs. - FY2024First statedAnnual report
「For the time being, we will prioritize development for relapsed/refractory acute myeloid leukemia and aim to obtain approval as soon as possible, while also considering the use of accelerated approval programs. We have formulated our plan to file for approval between 2026 and 2028 under the current clinical trial strategy on the assumption that the designation programs described above in Japan and overseas can be used.」
The company disclosed for the first time its plan for CTX-712 to prioritize relapsed/refractory AML for the time being and aim to file for approval between 2026 and 2028, assuming the use of accelerated approval programs and other measures.