SYBX - Synlogic rises ~10% as metabolic disorder drug gets FDA rare pediatric disease status

• The U.S. Food and Drug Administration (FDA) granted rare pediatric disease designation (RPDD) to Synlogic's ( NASDAQ: SYBX ) SYNB1934 to potentially treat phenylketonuria (PKU).
• PKU is a rare inherited disorder which causes an amino acid called phenylalanine to build up in the body due to mutations in the phenylalanine hydroxylase (PAH) gene. The PAH gene helps create the enzyme required to break down phenylalanine. The disorder can cause several health issues, including intellectual disabilities, brain damage and seizures.
• The FDA grants RPDD for serious diseases which mainly affect individuals from birth to 18 years of age, and fewer than 200K people in the U.S.
• "This is also extraordinary news as our program heads towards initiation of Synpheny-3, the pivotal Phase 3 study for SYNB1934 in PKU in the first half of the year," said Dave Hava, head of Research and Development.
• Synlogic another drug, SYNB1353, had received RPDD in December 2022 to treat homocystinuria (HCU), according to the company.
• SYBX +12.95% to $1.12 premarket Jan. 19

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