Synlogic announced that the European Medicines Agency issued a positive opinion on the company’s application for orphan designation for SYNB1934 for the treatment of phenylketonuria. "We are pleased that the EMA has issued a positive opinion for orphan designation for SYNB1934, in recognition of the urgent need for new treatment options for people living with this devastating disease," said Aoife Brennan, M.B. Ch.B., Synlogic President and CEO. "This designation also comes at a pivotal time as we prepare to begin our Phase 3 trial for PKU in the first half of this year."
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