Fortress Biotech, Inc. And Majority-Owned Subsidiary Cyprium Therapeutics, Inc. Sell Rare Pediatric Disease Priority Review Voucher For $205M Under Definitive Agreement Following FDA Approval Of ZYCUBO

Fortress Biotech, Inc. and its majority-owned subsidiary, Cyprium Therapeutics, Inc., announced that Cyprium has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for gross proceeds of $205 million, payable upon the closing of the transaction. In December 2023, Sentynl Therapeutics, Inc. assumed full responsibility for the development and commercialization of ZYCUBO (copper histidinate, previously known as CUTX-101) from Cyprium. 

The PRV was awarded following the approval of ZYCUBO by the U.S. Food and Drug Administration on January 12, 2026. Under the terms agreed with Sentynl, the PRV was transferred to Cyprium immediately following approval. Cyprium continues to be eligible for tiered royalties on net sales of ZYCUBO and up to $129 million in development and commercial milestone payments. As part of its obligations, Cyprium will pay 20% of the PRV sale proceeds to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, part of the National Institutes of Health.

Lindsay A. Rosenwald, M.D., Chairman, President, and Chief Executive Officer of Fortress and Chairman of Cyprium, noted that the FDA approval of ZYCUBO marked an important milestone for individuals living with Menkes disease. He added that the successful sale of the PRV demonstrates ongoing progress in executing value-driven corporate initiatives. Dr. Rosenwald highlighted that, alongside this transaction, Fortress has achieved three FDA approvals in the past 15 months—Emrosi™, UNLOXCYT™, and ZYCUBO—and recently completed the sale of its former subsidiary Checkpoint Therapeutics to Sun Pharma. He expressed confidence that these accomplishments strengthen the company’s ability to continue advancing its diverse portfolio of commercial and clinical-stage programs.

Lung S. Yam, M.D., Ph.D., President and Chief Executive Officer of Cyprium, shared that the team is pleased with the company’s recent momentum, particularly the approval of ZYCUBO for treating Menkes disease and the execution of the PRV sale agreement. He acknowledged the support received throughout this process and emphasized Cyprium’s commitment to advancing its AAV-ATP7A gene therapy program into clinical development, aiming to bring additional therapeutic options to patients affected by this rare and severe condition. The closing of the PRV sale remains subject to customary conditions, including the expiration of the applicable review period under the Hart-Scott-Rodino Antitrust Improvements Act.