Arcturus fast tracked for liver enzyme deficiency treatment

 Arcturus Therapeutics, Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ARCT-810, the Company’s mRNA therapeutic candidate for ornithine transcarbamylase (OTC) deficiency.

Fast Track Designation is designed to facilitate development and expedite review of new therapeutics intended to treat serious or life-threatening conditions that demonstrate the potential to address important unmet medical needs. Programs granted Fast Track Designation may receive important benefits including more frequent interactions with FDA review teams and the ability to obtain rolling review of a Biologics License Application (BLA). In addition, BLA applications may receive a priority review, with the FDA aiming to complete its review within six months, instead of the standard ten months review timeline.

https://www.biospace.com/article/releases/arcturus-therapeutics-receives-u-s-fda-fast-track-designation-for-arct-810-mrna-therapeutic-candidate-for-ornithine-transcarbamylase-deficiency/