Legacy Healthcare announced it has received feedback from the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan on conducting Phase 3 trial in Japanese patients and regulatory pathway toward potential marketing authorization. In the absence of Japanese patients in the RAAINBOW Phase 2/3 trial, PMDA allowed Cinainu to be evaluated in a Phase 3 trial in Japanese children, adolescents and adults with moderate to severe alopecia areata. Based on feedback from the PMDA, the data from the single Phase 3 registration trial, if positive, will serve as the basis to submit marketing authorization in Japan.