Lexington, MA-based Translate Bio (NASDAQ: TBIO) said Tuesday that the regulator verbally notified it of “additional clinical and nonclinical questions” about the company’s submission. The US Food and Drug Administration has placed a hold on a planned trial of Translate Bio’s messenger RNA (mRNA) drug, citing the need for answers to clinical and nonclinical questions regarding the firm’s submission. In an FDA notice published in July, the agency said it had received “significant concerns” about Translate, which is being developed by Transform Therapeutics Inc. (TTX) and its subsidiary Transgene Translate Bio 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 Translate Bio’s messenger RNA (mRNA) drug, citing the need for answers to clinical and nonclinical questions regarding the firm’s submission. In an FDA notice published in July, the agency said it had received “significant concerns” about Translate, which is being developed by Transform Therapeutics Inc. (TTX) and its subsidiary Transgene Translate Bio said it is expecting written confirmation to follow the verbal notification, and will work with the administration to resolve its queries.