Oyster Point Pharma, Inc.

Cabaletta Bio Announces Positive Clinical Updates for CABA-201 in Autoimmune Diseases

6 months ago

• Cabaletta Bio reported clinical data from RESET-Myositis™, RESET-SLE™, and initial data from RESET-SSc™ trials at ACR Convergence 2024, showcasing CABA-201's potential in autoimmune disease treatment. • Sixteen patients have been enrolled, with ten dosed across the RESET™ clinical development program, and 40 U.S. clinical sites are actively recruiting patients for CABA-201 trials. • Cabaletta anticipates a meeting with the FDA in 2025 to discuss potential registrational program designs for CABA-201, pending data outcomes. • EMA has authorized clinical trials for CABA-201 in Europe for lupus, expanding the clinical development program internationally.

Cabaletta Bio Advances CABA-201 Trials, Expands to Europe, and Reports $183M Cash Position

6 months ago

• Cabaletta Bio reports 40 active U.S. clinical sites recruiting for its RESET trials, with 16 patients enrolled and 10 dosed as of November 12. • The company received EMA CTA authorization for CABA-201 in lupus, facilitating expansion into Europe and broadening the clinical development program. • Clinical data from RESET-Myositis, RESET-SLE, and initial RESET-SSc trials will be presented at ACR Convergence 2024, highlighting potential efficacy. • Cabaletta Bio's cash position stands at $183.0 million as of September 30, 2024, expected to fund operations into the first half of 2026.