Capsida receives FDA fast track designation for its potential first in class IV administered gene therapy for STXBP1 developmental and epileptic encephalopathy

Capsida Biotherapeutics

29 May 2025 - Capsida previously received FDA orphan drug designation and IND clearance to initiate the SYNRGY Phase 1/2a clinical trial for CAP-002.

Capsida Biotherapeutics today announced the US FDA has granted fast track designation to its CAP-002 program.

Read Capsida Biotherapeutics press release

Michael Wonder

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Michael Wonder

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US , Gene therapy , Fast track