Reports Q2 revenue $35,000, consensus $130,000. “With our pivotal Phase 3 study, Synpheny-3, now underway, we are focused on trial execution and ensuring access, inclusion and an optimal experience for the patients who participate in this landmark study of a potential breakthrough in the management of PKU,” said Aoife Brennan, M.B. Ch.B., Synlogic President and Chief Executive Officer. “We were also pleased to share important regulatory milestones for the product candidate this quarter, including receipt of the FDA’s Fast Track designation, reenforcing the great medical need for this investigational medicine, and the World Health Organization’s approval of the international non-proprietary name for SYNB1934: labafenogene marselecobac.”
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- Synlogic grants Fast Track designation from FDA for SYNB1934
