Plano ng Cabaletta Bio na magsumite ng BLA sa 2027 para sa rese-cel sa myositis

Inihayag ng kumpanya ang pagkakahanay sa FDA sa 14-pasyenteng, single-arm na registrational cohort sa RESET-Myositis trial para sa dermatomyositis/antisynthetase syndrome. Lahat ng pasyente sa Phase 1/2 na nakakatugon sa pangunahing pamantayan ay nakamit ang 16-linggong pangunahing endpoint. Inaasahang magsisimula ang pagpapatala sa registrational cohort sa quarter na ito, na sumusuporta sa planong pagsumite ng BLA sa 2027.

Mahahalagang fact

Na-file: Nob 10, 2025, 12:33 PM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: CABACabaletta Bio
Asset: rese-cel
Pinagmulan: SEC 8-K
Kumpiyansa: May source
pangunahing endpoint: 16-linggong katamtaman o malaking tugon sa kabuuang marka ng pagpapabuti
laki ng registrational cohort: 14 pasyente

Sipi mula sa source

EX-99.1 2 caba-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Cabaletta Bio Reports Third Quarter 2025 Financial Results and Provides Business Update Rese-cel data presented at multiple medical meetings demonstrated potentially transformative, drug-free clinical responses with a favorable safety profile for autoimmune patients supporting outpatient use All myositis patients in the Phase 1/2 DM/ASyS cohort with sufficient follow-up who would have met key criteria for the registrational cohort met the registrational, 16-week primary endpoint Planned BLA submission for rese-cel in 2027 based on 14-patient, single-arm DM/ASyS registrational cohort initiating enrollment this quarter within the RESET-Myositis™ trial FDA alignment on additional registrational cohort designs for RESET-SSc™ and RES

SEC 8-K