Homology Medicines Inc FIXX:NASDAQ

Homology Medicines (FIXX) said Monday that the US Food and Drug Administration has lifted a clinical hold on a trial of the company's HMI-102 investigational gene therapy for adults with phenylketonuria, an inherited disorder that increases the levels of amino acid phenylalanine in the blood.

The move came after Homology addressed all clinical hold issues identified by the FDA, with changes to the protocol including a new steroid-sparing immunosuppression regimen that incorporates a T-cell inhibitor and a shorter course of steroids, the genetic medicines company said.

The clinical hold was related to elevated liver function tests seen in the trial, which were "all resolved with no hospitalizations required," Homology said.

Share of the company rose more than 4% in recent premarket activity.

Price: 2.24, Change: +0.09, Percent Change: +4.19