Fortress Biotech Subsidiary Cyprium Receives FDA Approval for ZYCUBO®, First Treatment for Menkes Disease

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The FDA approval of ZYCUBO® marks a pivotal milestone for Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, as it is the first and only approved treatment for the rare and often fatal Menkes disease in pediatric patients. This approval significantly de-risks the asset and validates Fortress Biotech's business model, which has now achieved three FDA approvals in the last 15 months. The issuance of a valuable Rare Pediatric Disease Priority Review Voucher (PRV) and the potential for up to $129 million in development and sales milestones, alongside tiered royalties from Sentynl Therapeutics, provide substantial financial upside for the company. The demonstrated clinical efficacy, showing a nearly 80% reduction in the risk of death for early-treated patients, underscores the significant medical need addressed by ZYCUBO®.

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• FDA Approval for ZYCUBO®

  The U.S. Food and Drug Administration (FDA) approved ZYCUBO® (copper histidinate) for the treatment of Menkes disease in pediatric patients, making it the first and only approved treatment for this rare, often fatal, condition.

• Rare Pediatric Disease Priority Review Voucher (PRV) Issued

  A valuable Rare Pediatric Disease Priority Review Voucher (PRV) was issued in connection with the FDA approval and will be transferred to Cyprium Therapeutics, Inc., a majority-owned subsidiary of Fortress Biotech.

• Significant Financial Upside

  Cyprium Therapeutics is eligible to receive tiered royalties on net sales of ZYCUBO® and up to $129 million in aggregate development and sales milestones from Sentynl Therapeutics, who holds commercialization rights.

• Strong Clinical Efficacy

  The approval is supported by positive clinical efficacy results demonstrating a nearly 80% reduction in the risk of death for Menkes disease subjects who received early treatment with ZYCUBO®, compared to an untreated control cohort.

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The FDA approval of ZYCUBO® marks a pivotal milestone for Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics, as it is the first and only approved treatment for the rare and often fatal Menkes disease in pediatric patients. This approval significantly de-risks the asset and validates Fortress Biotech's business model, which has now achieved three FDA approvals in the last 15 months. The issuance of a valuable Rare Pediatric Disease Priority Review Voucher (PRV) and the potential for up to $129 million in development and sales milestones, alongside tiered royalties from Sentynl Therapeutics, provide substantial financial upside for the company. The demonstrated clinical efficacy, showing a nearly 80% reduction in the risk of death for early-treated patients, underscores the significant medical need addressed by ZYCUBO®.