NS Pharma announces FDA accepted BLA submission of Regenxbio for RGX-121

NS Pharma, a subsidiary of Nippon Shinyaku, announced that the FDA has accepted for review the Biologics License Application, or BLA, submission by REGENXBIO (RGNX) for RGX-121, or clemidsogene lanparvovec, a potential first-in-class, investigational gene therapy for the treatment of Mucopolysaccharidosis II, or MPS II. The FDA granted REGENXBIO’s BLA Priority Review with a Prescription Drug User Fee Act target action date of November 9. In January, Nippon Shinyaku and REGENXBIO entered into a strategic partnership for the development and commercialization of RGX-121, as well as RGX-111, which is for the treatment of MPS I. Upon potential approval of RGX-121, NS Pharma will be exclusively responsible for commercializing RGX-121 in the U.S.