FDA lifts 4DMT clinical hold

Californian genetic medicines company 4D Molecular Therapeutics (Nasdaq: FDMT) is free to continue with its Phase I/II INGLAXA study for the gene therapy 4D-310 in Fabry disease cardiomyopathy.

The US Food and Drug Administration (FDA) has removed the clinical hold on the trial and enrollment is expected to resume in the second half of this year, the company revealed in its second-quarter earnings report.

A clinical hold was placed on the program early last year when 4DMT reported three cases of atypical hemolytic uremic syndrome in the first six patients enrolled in the program.