UPDATE: Fortress Biotech's Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million
MWN-AI** Summary
**Fortress Biotech's Cyprium Therapeutics Sells Rare Pediatric Disease Priority Review Voucher for $205 Million**
Fortress Biotech, Inc. announced that its subsidiary, Cyprium Therapeutics, has reached a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for a substantial $205 million. This agreement comes on the heels of the FDA's approval of ZYCUBO® (copper histidinate) on January 12, 2026, which is a significant advancement for children diagnosed with Menkes disease. The PRV was issued as a direct result of this FDA approval, and its immediate transfer to Cyprium occurred under the previous arrangement in which Sentynl Therapeutics assumed all responsibilities associated with ZYCUBO's development and commercialization.
Lindsay A. Rosenwald, MD, Chairman and CEO of Fortress, expressed confidence in the company's direction, noting this PRV sale demonstrates ongoing efforts to capitalize on corporate opportunities. Along with the recent approval of ZYCUBO, Fortress also secured three other FDA approvals within a 15-month span for various products, strengthening its position in the market. The agreement with Sentynl includes tiered royalties from ZYCUBO's sales and potential milestone payments that could total up to $129 million.
Furthermore, the PRV sale obligates Cyprium to allocate 20% of the proceeds to the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Dr. Lung S. Yam, Cyprium’s CEO, emphasized the company's commitment to advancing treatments for Menkes disease, including the preclinical AAV-ATP7A gene therapy program.
The transaction is subject to customary conditions, including regulatory approvals, but positions Cyprium favorably within the rare disease treatment landscape, complementing Fortress's extensive biopharmaceutical portfolio.
MWN-AI** Analysis
Fortress Biotech's recent announcement regarding its subsidiary Cyprium Therapeutics highlights a significant transaction that is likely to impact its market position favorably. The sale of the Rare Pediatric Disease Priority Review Voucher (PRV) for $205 million underscores Cyprium's strategic execution and showcases its ability to monetize assets generated from innovative developments.
This transaction follows the FDA approval of ZYCUBO (copper histidinate), which stands as a milestone for the treatment of Menkes disease in pediatric patients. This approval, alongside the recent sale of its former subsidiary Checkpoint Therapeutics, positions Fortress Biotech as a proactive player in the biopharmaceutical sector. The capital infusion from the PRV sale can enhance Fortress's liquidity, enabling the company to further invest in its existing pipeline and pursue additional strategic initiatives.
Investors should consider that while the $205 million from the PRV sale is a substantial influx of capital, Cyprium will also have an ongoing revenue stream from royalties on ZYCUBO's net sales, in addition to potential milestone payments, which can provide long-term value. The company remains eligible for further royalties and milestone payments associated with the development of its gene therapy, AAV-ATP7A, slated for clinical trials.
However, investors must remain cautious. The risks associated with development-stage products, regulatory hurdles, and market competition in the biopharmaceutical industry can impact future performance. As Cyprium continues to navigate through these challenges, the management’s ability to effectively execute its growth strategy will be crucial.
In summary, Fortress Biotech appears well-positioned for growth following this PRV sale, but potential investors should maintain a vigilant and informed approach, considering both the opportunities and inherent risks in the biotechnology landscape. Diversifying holdings within the sector may help mitigate exposure to volatility.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news 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
ir@fortressbiotech.com
Media Relations Contact:
Tony Plohoros
6 Degrees
(908) 591-2839
tplohoros@6degreespr.com
FAQ**
How might the successful sale of Cyprium's PRV impact the dividends associated with Fortress Biotech Inc. 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock FBIOP, given the company's focus on enhancing shareholder value?
Considering the tiered royalties from ZYCUBO sales, what implications could this have for the long-term financial stability of Fortress Biotech Inc. 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock FBIOP?
How does Cyprium's advancement in AAV-ATP7A gene therapy align with Fortress Biotech Inc. 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock FBIOP's growth strategy in rare disease treatments?
With the integration of ZYCUBO into Cyprium's portfolio, what steps will Fortress Biotech Inc. take to ensure that the performance of the 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock FBIOP reflects this emerging asset's potential?
**MWN-AI FAQ is based on asking OpenAI questions about Fortress Biotech Inc. 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock (NASDAQ: FBIOP).
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