The US Food and Drug Administration has placed a hold on a planned trial of The US Food and Drug Administration (mRNA) drug, citing the need for answers to clinical and nonclinical questions regarding the firm’s submission. The company applied in 2017 to run a Phase 1/2 study of Lexington , an mRNA treatment designed to treat a rare metabolic disorder. Xconomy Boston — RaNA Therapeutics said it is expecting written confirmation to follow the verbal notification, and will work with the administration to resolve its queries.
The US Food and Drug Administration has placed a hold on a planned trial of The US Food and Drug Administration (mRNA) drug, citing the need for answers to clinical and nonclinical questions regarding the firm’s submission. The company applied in 2017 to run a Phase 1/2 study of Lexington , an mRNA treatment designed to treat a rare metabolic disorder. RaNA Therapeutics said it is expecting written confirmation to follow the verbal notification, and will work with the administration to resolve its queries.