Fortress Biotech’s Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million
Rhea-AI Summary
Fortress Biotech (Nasdaq: FBIO) subsidiary Cyprium Therapeutics entered a definitive agreement to sell a Rare Pediatric Disease Priority Review Voucher for $205 million in gross proceeds upon closing. The PRV was issued following FDA approval of ZYCUBO on January 12, 2026 and was transferred to Cyprium.
Cyprium remains eligible for tiered royalties on ZYCUBO net sales and up to $129 million in aggregate milestones from Sentynl; 20% of PRV sale proceeds are payable to the Eunice Kennedy Shriver NICHD. The deal is subject to customary closing conditions, including the HSR waiting period.
Positive
- PRV sale expected to bring $205 million gross proceeds
- Cyprium eligible for up to $129 million in milestones
- Ongoing tiered royalties on net sales of ZYCUBO
- Company cites three FDA approvals in the last 15 months
Negative
- 20% of PRV proceeds payable to Eunice Kennedy Shriver NICHD
- Transaction subject to HSR waiting period, which may delay closing
Key Figures
Market Reality Check
Peers on Argus
FBIO was down 3.45% while 4 Argus-scanned biotech peers (e.g., IKT, KALA, IOBT, SPRO) moved up (median 7.2%). The opposite direction suggests today’s PRV sale news is more stock-specific than sector-driven.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Jan 13 | ZYCUBO FDA approval | Positive | -7.1% | First and only U.S. approval for Menkes disease with strong survival data. |
| Dec 15 | NDA resub acceptance | Positive | +13.3% | FDA accepted CUTX-101 NDA resubmission with new PDUFA action date. |
| Dec 10 | Emrosi Phase 1 data | Positive | +3.5% | Phase 1 Emrosi trial met primary endpoints with favorable safety profile. |
| Nov 14 | Q3 2025 earnings | Positive | +5.2% | Revenue growth and move to quarterly net income with stronger cash. |
| Nov 12 | Journey Q3 results | Neutral | -2.2% | Emrosi-driven revenue growth but business remains in modest net loss. |
Positive regulatory and clinical milestones have often aligned with positive price reactions, but the recent ZYCUBO FDA approval saw a notable negative divergence.
Over the last few months, Fortress has reported several value-creating events. On Nov 14, 2025, Q3 2025 results showed higher revenue and a swing to profitability. Subsequent earnings and clinical updates from Journey Medical highlighted Emrosi’s growth. Regulatory progress for CUTX-101 culminated in FDA approval of ZYCUBO on Jan 13, 2026, with a Rare Pediatric Disease PRV and up to $129 million in potential milestones. Today’s news monetizes that PRV, extending the same ZYCUBO/Sentynl value chain highlighted in prior releases.
Market Pulse Summary
This announcement crystallizes significant non-dilutive value: Cyprium agreed to sell its Rare Pediatric Disease PRV for $205 million while retaining eligibility for up to $129 million in milestones and tiered royalties on ZYCUBO. The deal follows ZYCUBO’s FDA approval on January 12, 2026 and extends an already active period of approvals across Fortress’s portfolio. Investors may watch for closing of the transaction, HSR clearance, and subsequent deployment of proceeds across Fortress’s commercial and clinical assets.
Key Terms
priority review voucher regulatory
rare pediatric disease medical
AI-generated analysis. Not financial advice.
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
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
“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 reach profitability this year. 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 much will Fortress Biotech (FBIO) receive from the PRV sale?
What future payments can Cyprium expect related to ZYCUBO after the PRV sale?
Why was the PRV available for sale after ZYCUBO approval for FBIO (Fortress)?
Will the PRV sale for FBIO require regulatory clearance before closing?
How does the PRV sale affect Fortress Biotech's path to profitability (FBIO)?
