Cabaletta Bio: Nasa tamang landas ang pagsusumite ng BLA para sa rese-cel sa myositis para sa 2027

Ang registrational DM/ASyS cohort sa RESET-Myositis ay kasalukuyang nag-eenroll ng 17 pasyente na may 16-linggong primary endpoint at outpatient dosing option. Kung matagumpay, ang data mula sa cohort na ito ay susuporta sa unang inaasahang BLA submission ng Cabaletta para sa rese-cel sa myositis sa 2027.

Mahahalagang fact

Na-file: Mar 23, 2026, 11:32 AM
Kaganapan: Naisumite ang aplikasyon
Direksyon: Positibo
Kumpanya: CABACabaletta Bio
Asset: rese-cel
Pinagmulan: SEC 8-K
Kumpiyansa: May source

Sipi mula sa source

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