Synlogic grants Fast Track designation from FDA for SYNB1934

Synlogic announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to labafenogene marselecobac, SYNB1934, for the treatment of phenylketonuria. Labafenogene marselecobac has also received Rare Disease Designation and Orphan Drug Designation by the FDA and orphan designation from the European Medicines Agency. “We are pleased that this potentially transformative therapy has now received three important regulatory designations from the FDA, and orphan designation from the EMA, reflecting a shared understanding of the urgent need for new medical treatment options that can effectively and safely lower Phe levels in patients with PKU,” said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. “This milestone re-enforces our own urgency as we execute our pivotal study, Synpheny-3.”