regulatory
confidence high
sentiment positive
materiality 0.50
Synlogic receives FDA Rare Pediatric Disease Designation for SYNB1934 in PKU
SYNLOGIC, INC.
- FDA granted RPDD for SYNB1934, a synthetic biotic candidate for phenylketonuria (PKU).
- Company plans to start Synpheny-3 pivotal Phase 3 study for SYNB1934 in H1 2023.
- Follows similar RPDD for SYNB1353 for homocystinuria (HCU) received in December 2022.
- Designation highlights the urgent need for new PKU treatment options in children.