Synlogic Receives Rare Pediatric Disease Designation from FDA for SYNB1934 for Phenylketonuria (PKU)
“This designation for SYNB1934 demonstrates the urgent need for new PKU treatment options for patients, especially children,” said Dave Hava, Head of Research and Development. “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.”
About Rare Pediatric Disease Designation
The FDA grants RPDD for serious and life-threatening diseases that primarily affect individuals from birth to 18 years old and fewer than 200,000 persons in the
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Source: Synlogic, Inc.