REGENXBIO Rises In Premarket As FDA Says No New Studies Needed For NAVSUNLI BLA Resubmission

REGENXBIO said the U.S. FDA agreed that no additional studies are required for resubmission of the BLA for NAVSUNLI, its one-time gene therapy for Hunter syndrome (MPS II). The regulatory clarification reduces development risk and supports a cleaner path toward potential approval. Shares rose on the update, which is constructive for the company’s near-term biotech catalyst profile.

Analysis

REGENXBIO said the U.S. FDA agreed that no additional studies are required for resubmission of the BLA for NAVSUNLI, its one-time gene therapy for Hunter syndrome (MPS II). The regulatory clarification reduces development risk and supports a cleaner path toward potential approval. Shares rose on the update, which is constructive for the company’s near-term biotech catalyst profile.