Edimer Pharmaceuticals Inc. is poised to begin the first human trials of a protein-replacement therapy for XLHED, a disorder that impacts the development of teeth, hair and skin. Although the start-up is planning to test its therapy first in adults, Edimer's ultimate goal is to permanently correct the disorder by treating developing fetuses in utero. The company's compound is designed to cross the placental barrier, so that it can bind an endogenous receptor and trigger normal fetal development with just a single treatment.

The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.

Move was meant to preempt others’ efforts to secure the next six months of Regeneron’s COVID-19 antibody therapeutic.