LogicBio rocked by FDA clinical hold on genome editing trial

The FDA has placed a clinical hold on LogicBio Therapeutics’ planned genome editing trial. LogicBio wants to trial the therapy in methylmalonic acidemia (MMA) patients aged two years and up but has run into resistance at the FDA. Details of the nature of the regulatory resistance and how soon it is likely to be resolved are scarce. LogicBio provided scant information in its statement to disclose the FDA clinical hold. According to analysts at Jefferies who spoke to management at LogicBio, the lack of information in the statement reflects the fact the biotech is yet to learn what the FDA wants to see before it lifts the clinical hold. LogicBio’s regulatory point person reportedly learned of the clinical hold during a conversation with the FDA project manager. The questions the FDA wants LogicBio to answer were not discussed on the call.