Cabaletta Bio: pengajuan BLA rese-cel untuk myositis sesuai jadwal pada 2027

Kohort DM/ASyS registrasional dalam RESET-Myositis kini sedang merekrut 17 pasien dengan titik akhir primer 16 minggu dan opsi dosis rawat jalan. Jika berhasil, data dari kohort ini akan mendukung pengajuan BLA pertama Cabaletta untuk rese-cel pada myositis pada 2027.

Fakta utama

Diajukan: 23 Mar 2026, 11.32
Peristiwa: Permohonan diajukan
Arah: Positif
Perusahaan: CABACabaletta Bio
Aset: rese-cel
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 caba-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 Cabaletta Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Rese-cel myositis BLA submission on track for 2027 based on a 17-patient, single arm registrational cohort design, including an outpatient dosing option No-preconditioning program enrolling in lupus and PV; anticipating initial RESET-SLE™ data in 1H26 and durability data from the RESET-SLE and RESET-PV ® trials throughout 2026 Automated manufacturing of rese-cel with Cellares’ Cell Shuttle™ underway in the RESET™ clinical program, offering the potential to produce rese-cel for thousands of patients per year with minimal capital investment Pivotal trial designs announced for SLE and LN single arm cohorts, each with ~25 patients;

SEC 8-K