Cabaletta Bio Gets FDA OK to Study CABA-201 in Generalized Myasthenia Gravis

By Colin Kellaher

Cabaletta Bio has won Food and Drug Administration authorization to launch a Phase 1/2 study of its CABA-201 investigational therapy in patients with the rare autoimmune disease generalized myasthenia gravis.

The Philadelphia clinical-stage biotechnology company on Monday said the green light expands the clinical development of its lead product candidate beyond rheumatology into neurology, adding that it plans to initiate a study across two parallel patient cohorts based on autoantibody status.

Cabaletta--which previously received FDA approvals to study CABA-201 in lupus, myositis and systemic sclerosis--said it is on track to deliver initial clinical data from patients with lupus and/or myositis in the first half of 2024.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 06, 2023 07:40 ET (12:40 GMT)

Cabaletta Bio (NASDAQ:CABA)
Historical Stock Chart
From Apr 2024 to May 2024