Cyprium Therapeutics agrees to sell Rare Pediatric Disease Priority Review Voucher for $205 million, enhancing its corporate strategy.
Quiver AI Summary
Fortress Biotech, Inc. and its subsidiary Cyprium Therapeutics have announced an agreement to sell a Rare Pediatric Disease Priority Review Voucher for $205 million. This voucher was obtained following the FDA approval of ZYCUBO for treating Menkes disease in January 2026. Sentynl Therapeutics took over the development and commercialization of ZYCUBO from Cyprium in December 2023, and the voucher was quickly transferred to Cyprium, which is also set to receive potential royalties and milestone payments from Sentynl. Cyprium has expressed commitment to advancing gene therapy options for Menkes disease alongside its recent corporate developments and FDA approvals. The transaction is pending standard regulatory approvals.
Potential Positives
- Cyprium Therapeutics successfully entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $205 million, highlighting strong financial execution.
- The approval of ZYCUBO by the FDA represents a significant milestone in the development of treatments for Menkes disease, enhancing Fortress Biotech's reputation in the biopharmaceutical industry.
- Fortress Biotech has achieved three FDA approvals in the last 15 months, demonstrating its capability to develop and commercialize valuable pharmaceutical products.
- The company remains well positioned for future growth with ongoing potential revenue from royalties and milestones associated with ZYCUBO and other pipeline assets.
Potential Negatives
- The sale of the Rare Pediatric Disease Priority Review Voucher (PRV) could signify underlying cash flow issues or a lack of independent revenue generation, necessitating asset liquidations.
- Cyprium's reliance on third parties, such as Sentynl Therapeutics, for the commercialization of ZYCUBO indicates potential dependency risks that may affect future profitability and operational control.
- The company's obligations to pay 20% of the PRV sale proceeds to the NIH reflects ongoing financial commitments that could impact its net gains from the transaction.
FAQ
What is the recent transaction involving Cyprium Therapeutics?
Cyprium entered into an asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher for $205 million.
What does the Priority Review Voucher sale signify for Cyprium?
The sale demonstrates Cyprium's ability to generate value through corporate transactions, enhancing its financial position.
What is ZYCUBO and why is it significant?
ZYCUBO is an FDA-approved treatment for Menkes disease, marking a major milestone for pediatric patients affected by this condition.
What are the future financial expectations for Cyprium?
Cyprium anticipates receiving tiered royalties on ZYCUBO sales and up to $129 million in development and sales milestones from Sentynl.
Who is responsible for developing and commercializing ZYCUBO?
Sentynl Therapeutics has assumed full responsibility for the development and commercialization of ZYCUBO after its approval.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
MIAMI, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that Cyprium entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (“PRV”) for gross proceeds of $205 million upon the closing of the transaction.
In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”) assumed full responsibility for the development and commercialization of ZYCUBO® (copper histidinate, formerly known as CUTX-101) from Cyprium. The PRV was issued upon approval of ZYCUBO by the U.S. Food and Drug Administration (“FDA”) on January 12, 2026. Pursuant to the transaction with Sentynl, the PRV was immediately transferred to Cyprium. Cyprium remains eligible to receive tiered royalties on net sales of ZYCUBO and up to $129 million in aggregate development and sales milestones from Sentynl. Cyprium is also obligated to pay 20% of the proceeds from a PRV sale to the Eunice Kennedy Shriver National Institute of Child Health and Human Development, an institute of the National Institutes of Health.
“The recent approval of ZYCUBO was a significant achievement for patients with Menkes disease and the sale of the PRV by Cyprium shows our continued execution in value-generating corporate transactions,” said Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer and Cyprium’s Chairman. “With the PRV sale and three FDA approvals received in the last 15 months for Emrosi™, UNLOXCYT™, and ZYCUBO, in addition to the recent sale of our former subsidiary Checkpoint Therapeutics to Sun Pharma, we believe that we are well positioned to continue to execute on our portfolio. We look forward to the potential achievement of upcoming milestones across our extensive pipeline of commercial and clinical-stage assets.”
“We are very pleased with the recent progress at Cyprium, which includes the approval of ZYCUBO for the treatment of Menkes disease along with the execution of this important agreement,” said Lung S. Yam, M.D., Ph.D., Cyprium’s President and Chief Executive Officer. “We are deeply grateful for everyone's support and look forward to advancing AAV-ATP7A Gene Therapy toward clinical development to provide additional therapeutic options for patients with Menkes disease.”
The transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino (HSR) Antitrust Improvements Act.
About Cyprium Therapeutics
Cyprium Therapeutics, Inc. (“Cyprium”) is focused on the development of novel therapies for the treatment of Menkes disease and related copper metabolism disorders. In March 2017, Cyprium entered into a Cooperative Research and Development Agreement with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (“NICHD”), part of the NIH, to advance the clinical development of CUTX-101 (Copper Histidinate injection) for the treatment of Menkes disease. In 2023, Cyprium completed the transfer of its proprietary rights and assigned its FDA documents pertaining to CUTX-101 to Sentynl Therapeutics, Inc. ZYCUBO (formerly CUTX-101) was U.S. FDA-approved in 2026 for the treatment of Menkes disease in pediatric patients. Cyprium and NICHD also have an ongoing worldwide, exclusive license agreement to develop and commercialize adeno-associated virus (AAV)-based gene therapy, called AAV-ATP7A, to deliver working copies of the copper transporter that is defective in patients with Menkes disease, and to be used in combination with CUTX-101; AAV-ATP7A gene therapy is currently in pre-clinical development and has received FDA Orphan Drug Designation. Cyprium was founded by, and is a majority-owned subsidiary of, Fortress Biotech, Inc. (Nasdaq: FBIO). For more information, visit
www.cypriumtx.com
.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty income. The company has eight marketed prescription pharmaceutical products and multiple programs in development at Fortress, at its majority-owned and majority-controlled partners and subsidiaries and at partners and subsidiaries it founded and in which it holds significant minority ownership positions. Fortress’ portfolio is being commercialized and developed for various therapeutic areas including oncology, dermatology, and rare diseases. Fortress’ model is focused on leveraging its significant biopharmaceutical industry expertise and network to further expand and advance the company’s portfolio of product opportunities. Fortress has established partnerships with some of the world’s leading academic research institutions and biopharmaceutical companies to maximize each opportunity to its full potential, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children’s Hospital, Columbia University, Dana Farber Cancer Center and Sentynl Therapeutics. For more information, visit
www.fortressbiotech.com
.
Forward-Looking Statements
Statements in this press release that are not descriptions of historical facts are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. The words “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “might,” “plans,” “potential,” “predicts,” “should,” or “will” or the negative of these terms or other comparable terminology are generally intended to identify forward-looking statements. These forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated include risks relating to: the possibility that the proposed transaction may not be completed in the time frame expected by Cyprium and/or Fortress, or at all; our growth strategy, financing and strategic agreements and relationships; our need for substantial additional funds and uncertainties relating to financings; uncertainty related to the timing and amounts expected to be realized from future milestone, contingent value right, royalty or similar future revenue streams, if at all; our ability to identify, acquire, close and integrate product candidates successfully and on a timely basis; our ability to attract, integrate and retain key personnel; the early stage of products under development; the results of research and development activities; uncertainties relating to preclinical and clinical testing; our ability to obtain regulatory approval for products under development; our ability to successfully commercialize products or other marketable assets for which we receive regulatory approval; our ability to secure and maintain third-party manufacturing, marketing and distribution of our and our partner companies’ products and product candidates; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as may be required by law, and we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The information contained herein is intended to be reviewed in its totality, and any stipulations, conditions or provisos that apply to a given piece of information in one part of this press release should be read as applying
mutatis mutandis
to every other instance of such information appearing herein.
Company Contact:
Jaclyn Jaffe
Fortress Biotech, Inc.
(781) 652-4500
[email protected]
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
[email protected]