Investing.com — Shares of Regenxbio Inc . (NASDAQ:) surged 18.4% in pre-open trading Tuesday following the announcement of a strategic partnership with Nippon Shinyaku Co., Ltd. for the development and commercialization of gene therapies RGX-121 and RGX-111. The collaboration focuses on treatments for Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome, and Mucopolysaccharidosis I (MPS I), or Hurler syndrome.
Under the terms of the agreement, Regenxbio will receive $110 million at closing, with the potential for an additional $700 million tied to developmental, regulatory, and sales milestones. The deal also includes meaningful double-digit royalties on net sales within the U.S. and Asia, which the companies refer to as the “Licensed Territory.”
Regenxbio’s President and CEO, Curran M. Simpson, expressed enthusiasm about the partnership, emphasizing the combined strengths of both companies and the potential to bring transformative gene therapies to key markets. Simpson highlighted the prospects of RGX-121, which could become the first gene therapy for MPS II with a possible FDA approval by late 2025. Additionally, RGX-111 has shown promising results in a Phase 1/2 study.
The alliance leverages Regenxbio’s expertise in gene therapy manufacturing, while Nippon Shinyaku will handle the commercialization of both products in the Licensed Territory. Regenxbio retains the right to develop and commercialize the products outside of this territory and will maintain all rights to any proceeds from the sale of the Priority Review Voucher (PRV) for RGX-121 upon potential approval.
The transaction is set to close by the end of the first quarter of 2025, pending customary conditions, including regulatory approvals. This strategic partnership marks a significant milestone for Regenxbio as it aims to lead in the gene therapy space for rare diseases, with the support of Nippon Shinyaku’s commercial capabilities and focus on rare diseases.
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