Record mula sa primary source
Decision-gradePagbabago sa trial registry
Dianthus: Maagang desisyong GO sa Phase 3 CAPTIVATE CIDP trial para sa claseprubart
Naabot ng kumpanya ang maagang desisyong GO sa Phase 3 CAPTIVATE trial ng claseprubart sa CIDP matapos makamit ang 20 kumpirmadong tumugon na may mas kaunti sa 40 planadong kalahok na nakumpleto ang open-label Part A. Naabot ang milestone na ito bago ang dating itinakdang timeline na Q2 2026 batay sa pamantayan ng 50% o higit na rate ng pagtugon. Inaasahan na ngayon ng kumpanya na magbigay ng Part B top-line guidance sa pagtatapos ng taon 2026.
Mahahalagang fact
- Na-file
- Mar 9, 2026, 11:19 AM
- Kaganapan
- Pagbabago sa trial registry
- Direksyon
- Positibo
- Kumpanya
DNTHDianthus- Asset
- claseprubart
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Mga tumugon
- 20 kumpirmadong tumugon
- Mga kalahok
- <40 planadong kalahok
Sipi mula sa source
EX-99.1 2 dnth-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 DIANTHUS THERAPEUTICS HIGHLIGHTS RECENT BUSINESS ACHIEVEMENTS, INCLUDING GO DECISION FOR PHASE 3 CAPTIVATE CIDP TRIAL, AND REPORTS Q4 AND FY 2025 FINANCIAL RESULTS Early GO decision reached in CAPTIVATE ahead of Q2’26 guidance based on GO criteria of 20 confirmed responders achieved with less than 40 planned participants completing open-label Part A Phase 3 registrational trial of claseprubart evaluating 300mg/2mL Q2W and 300mg/2mL Q4W in generalized Myasthenia Gravis (gMG) expected to initiate in mid-2026; top-line results anticipated in 2H’28 Phase 2 MoMeNtum trial of claseprubart in Multifocal Motor Neuropathy (MMN) ongoing; top-line results on track for 2H’26 Phase 1 healthy volunteer data for DNTH212 anticipated in 2H’26; updat