Synlogic's SYNB1934 Gets FDA Rare Pediatric Disease Designation For Phenylketonuria

(RTTNews) - Synlogic, Inc. (SYBX), a provider of advancing therapeutics based on synthetic biology, announced Thursday that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation for its SYNB1934 for the potential treatment of phenylketonuria or PKU.

Synlogic shares were gaining around 13 percent in pre-market activity on Nasdaq.

Dave Hava, Head of Research and Development, said, "This designation for SYNB1934 demonstrates the urgent need for new PKU treatment options for patients, especially children. 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."

The FDA grants Rare Pediatric Disease Designation or 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 U.S.

With RPDD, the sponsor may be entitled to receive a pediatric priority review voucher or pPRV if the drug is initially approved for that rare childhood disease.

Synlogic's SYNB1353 in December 2022 received RPDD for the potential treatment of homocystinuria or HCU.

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