Crenessity: which risks did reviewers probe?

“The changes in leukocytic parameters and lymphocyte subpopulation and T-cell-dependent antibody responses were small in magnitude and occurred in one sex (males) and showed no remarkable evidence of immunotoxicity in rats.”

“Crinecerfont crossed the placenta and distributed to the fetal liver (at low levels) in pregnant rats and rabbits. Low crinecerfont exposure was observed in brain, skin, and testis.”

“The overall incidence of fetal malformations was low and there was no clear relationship to drug, but absent similar findings in concurrent control fetuses, and with the incidence being outside the historical control range for individual malformations, we cannot rule out a possible effect of crinecerfont treatment on rabbit embryo-fetal development.”