other material
confidence high
sentiment neutral
materiality 0.65
4D Molecular Therapeutics increases wet AMD trial enrollment to 480 patients for global regulatory submissions
4D Molecular Therapeutics, Inc.
- Target enrollment for 4FRONT-1 and 4FRONT-2 Phase 3 trials raised from 400 to 480 patients each.
- Amendments aim for ~90% power with ~4-letter noninferiority margin for non-FDA agencies (e.g., PMDA, EMA).
- No impact on guided enrollment completion or financial runway into H2 2028; 4FRONT-1 topline expected H1 2027.
- Asia-Pacific regulatory submissions supported by Otsuka partnership, leveraging global commercial opportunity.