REGENXBIO will acquire Dimension Therapeutics in an all-stock transaction for an implied value of approximately $3.41 per share. The boards of directors of both companies have unanimously approved the transaction.

Upon completion of the acquisition, REGENXBIO will add two lead product candidates to its pipeline:

• DTX301 for the treatment of ornithine transcarbamylase (OTC) deficiency, which is designed to use the NAV AAV8 vector to deliver a copy of the OTC gene to liver cells. DTX301 is being evaluated under an active investigational new drug (IND) application for a phase I/II clinical trial; and
• DTX401 for the treatment of glycogen storage disease type Ia (GSDIa), which is designed to use the NAV AAV8 vector to deliver a copy of the glucose-6-phosphatase (G6Pase) gene to liver cells. An IND application is anticipated to be filed for DTX401 in early 2018.

Both DTX301 and DTX401 have been granted Orphan Drug Designation in the U.S. and Europe.

In addition, REGENXBIO will acquire DTX201 for the treatment of hemophilia A. DTX201 is designed to use REGENXBIO’s NAV Technology to deliver a copy of the Factor VIII gene to liver cells, and is partnered through a global development and commercialization collaboration with Bayer. An IND application is anticipated to be filed for DTX201 in early 2018.

“This acquisition confirms REGENXBIO’s leadership in the field of AAV gene therapy and expands our pipeline in metabolic diseases using NAV Technology with a clinical asset and several preclinical assets. REGENXBIO has the resources and expertise to be successful in advancing a portfolio of gene therapies for inherited metabolic diseases targeting the liver,” said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO.

“We believe that DTX301 and DTX401 are product candidates that address diseases with high unmet need and will become an important part of a strong internal pipeline at REGENXBIO that has the potential to achieve multiple milestones through the end of 2018, starting with our interim updates anticipated for the end of this year on RGX-314 for wet AMD and RGX-501 for HoFH. The acquisition of Dimension is another meaningful step in building a robust clinical pipeline of gene therapy product candidates with the goal of improving treatment options for patients and families in many diseases.”

Through the transaction, REGENXBIO will also acquire preclinical product candidates for phenylketonuria (PKU), Wilson disease and citrullinemia type I, manufacturing technology and other intellectual property developed by Dimension. All Dimension candidates—including DTX301 and DTX401—utilize REGENXBIO’s NAV Technology and have been developed under exclusive licenses previously granted by REGENXBIO to Dimension.

Under the terms of the definitive agreement, Dimension will, following consummation of the acquisition, become a wholly owned subsidiary of REGENXBIO. In addition, Dimension shareholders will receive 0.1573 shares of REGENXBIO in exchange for each of their shares in Dimension and are expected to own approximately 10.9% of the combined entity. It is anticipated that the transaction will close by year-end 2017, subject to approval by Dimension shareholders, receipt of any required customary regulatory approvals and the satisfaction of other customary closing conditions.