Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics announced that Cyprium entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher for gross proceeds of $205M upon the closing of the transaction. In December 2023, Sentynl Therapeutics assumed full responsibility for the development and commercialization of ZYCUBO from Cyprium. The PRV was issued upon approval of ZYCUBO by the U.S. Food and Drug Administration on January 12, 2 ...

Core Viewpoint - Fortress Biotech, Inc. and its subsidiary Cyprium Therapeutics announced the sale of a Rare Pediatric Disease Priority Review Voucher for $205 million, highlighting the company's strategic focus on value-generating transactions and advancements in their product pipeline [1][3]. Company Developments - Cyprium Therapeutics has transferred the development and commercialization rights of ZYCUBO to Sentynl Therapeutics, which was approved by the FDA on January 12, 2026, for treating Menkes disease [2]. - The PRV was issued following the FDA approval of ZYCUBO, and Cyprium is set to receive tiered royalties on net sales and up to $129 million in development and sales milestones from Sentynl [2]. - Cyprium is obligated to pay 20% of the PRV sale proceeds to the Eunice Kennedy Shriver National Institute of Child Health and Human Development [2]. Strategic Positioning - Fortress Biotech's Chairman emphasized the significance of the PRV sale and recent FDA approvals for their products, indicating a strong position to execute on their portfolio [3]. - Cyprium's recent achievements include the approval of ZYCUBO and the execution of the asset sale, with plans to advance AAV-ATP7A Gene Therapy for Menkes disease [3]. Company Background - Cyprium Therapeutics focuses on developing therapies for Menkes disease and related disorders, having established a partnership with the Eunice Kennedy Shriver National Institute of Child Health and Human Development for clinical development [4]. - Fortress Biotech is an innovative biopharmaceutical company with a diverse portfolio, including eight marketed products and multiple development programs across various therapeutic areas [5].

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 ...

Group 1 - The article does not provide any specific insights or analysis related to companies or industries, focusing instead on the author's credentials and disclosures [1][2][3]

Core Insights - The FDA has approved ZYCUBO (copper histidinate) for the treatment of Menkes disease in pediatric patients, marking it as the first and only FDA-approved treatment for this condition [1][4][9] - Cyprium Therapeutics, a subsidiary of Fortress Biotech, will receive a Rare Pediatric Disease Priority Review Voucher (PRV) and is eligible for tiered royalties and up to $129 million in development and sales milestones from Sentynl Therapeutics [2][4] Company Developments - Fortress Biotech and Cyprium Therapeutics announced the FDA approval of ZYCUBO, which is a significant milestone for both the company and patients suffering from Menkes disease [4] - The approval of ZYCUBO is supported by positive clinical efficacy results, showing a nearly 80% reduction in the risk of death for patients receiving early treatment compared to an untreated control cohort [4][9] Product Information - ZYCUBO is a subcutaneous injectable formulation that restores copper homeostasis in patients with Menkes disease, a rare genetic disorder caused by mutations in the ATP7A gene [3][9] - The drug has received multiple designations from the FDA, including Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designation [6] Market Context - Menkes disease has a minimum birth prevalence of 1 in 34,810 live male births, with potentially higher rates based on recent studies [7][8] - The condition is characterized by severe neurological symptoms and high mortality rates in untreated cases, emphasizing the need for effective treatments like ZYCUBO [8]

Core Viewpoint - Fortress Biotech Inc. (FBIO) shares have increased over 3% to $4.40 in premarket trading due to its subsidiary Cyprium Therapeutics nearing a significant FDA decision regarding CUTX-101, a treatment for Menkes disease, with a decision expected by January 14, 2025 [1][4] Group 1: FDA Decision and Product Development - CUTX-101 is a subcutaneous injectable formulation of copper histidinate, developed by Cyprium for Menkes disease, and is awaiting its second review by the FDA [1] - The FDA previously declined to approve CUTX-101 in October 2023 due to concerns about the manufacturing site's cGMP compliance [2] - The development and commercialization responsibilities for CUTX-101 were fully transferred to Sentynl Therapeutics in December 2023, with Cyprium eligible to receive up to $129 million in development and sales milestones, along with royalties on net sales [2] Group 2: Menkes Disease Overview - Menkes disease is caused by mutations in the ATP7A gene, which regulates copper metabolism, leading to severe clinical symptoms including sparse hair, connective tissue issues, neurological symptoms, and high mortality rates in untreated cases [3] - If approved, CUTX-101 will be the first and only FDA-approved treatment for Menkes disease [4]

Group 1: Market Movements - Several biotech and healthcare companies experienced notable gains in after-hours trading, driven by earnings updates, guidance announcements, and broader investor sentiment [1] - FibroBiologics, Inc. (FBLG) led with a 7.68% increase, closing at $0.41, suggesting speculative interest or technical momentum [1] - Nyxoah SA (NYXH) advanced 3.94% to $5.28 after reporting preliminary results for Q4 and full year 2025, along with revenue guidance for Q1 2026 [2] - Fortress Biotech, Inc. (FBIO) climbed 6.90% to $4.49, continuing a trend of volatility despite no new news [2] - Revvity, Inc. (RVTY) gained 4.92% to close at $109.00, with investors likely reacting to a previous collaboration announcement with Eli Lilly [3] - Option Care Health, Inc. (OPCH) rose 3.28% to $33.11 after releasing preliminary unaudited financial results for Q4 and full year 2025, along with guidance for 2026 [4] - Actinium Pharmaceuticals, Inc. (ATNM) added 3.02% to close at $1.34, reflecting investor activity in the broader biotech sector [4] - Design Therapeutics, Inc. (DSGN) gained 1.97% to $9.30, indicating continued interest despite no specific news [5] Group 2: Company-Specific Developments - FibroBiologics, Inc. (FBLG) showed a significant rise without any company-specific news, indicating potential speculative interest [1] - Nyxoah SA (NYXH) provided revenue guidance for Q1 2026, which bolstered investor confidence in its growth trajectory [2] - Revvity, Inc. (RVTY) is expanding access to predictive models through a collaboration with Eli Lilly, aimed at accelerating AI-enabled drug discovery [3] - Option Care Health, Inc. (OPCH) released preliminary financial results and guidance, contributing to its positive after-hours reaction [4]

As filed with the Securities and Exchange Commission on December 15, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FORTRESS BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 20-5157386 (State or other jurisdiction of incorporation or organization) 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 (Address, including zip code, and telephone number, includ ...

Core Viewpoint - The FDA has set a new PDUFA target action date of January 14, 2026, for the resubmission of the New Drug Application (NDA) for CUTX-101, a treatment for Menkes disease in pediatric patients [1][2]. Group 1: FDA Resubmission and Approval Process - The resubmission of the NDA for CUTX-101 has been accepted as a Class 1 resubmission, leading to the new PDUFA target action date [2]. - Sentynl Therapeutics, Inc. has taken full responsibility for the development and commercialization of CUTX-101 from Cyprium, following a complete response letter (CRL) from the FDA that did not raise concerns about the drug's efficacy and safety [3][5]. - The CRL issued on September 30, 2025, cited issues related to the manufacturing site's cGMP compliance but did not identify any deficiencies in the clinical data supporting CUTX-101 [3]. Group 2: Financial and Developmental Aspects - Upon approval, Sentynl will transfer a Rare Pediatric Disease Priority Review Voucher (PRV) to Cyprium and Cyprium will be eligible for royalties on net sales of CUTX-101, along with up to $129 million in development and sales milestones [4]. - The NDA for CUTX-101 was initially granted Priority Review by the FDA, supported by positive clinical efficacy results demonstrating significant improvement in overall survival for patients with Menkes disease [5]. Group 3: Menkes Disease Overview - Menkes disease is a rare X-linked recessive pediatric condition caused by mutations in the copper transporter ATP7A, with a birth prevalence estimated between 1 in 34,810 and 1 in 8,664 live male births [6]. - The disease is characterized by severe neurological symptoms and high mortality rates in untreated cases, with many patients not surviving past the age of 2-3 years [6]. Group 4: Company Background - Cyprium Therapeutics focuses on developing therapies for Menkes disease and related copper metabolism disorders, having entered into a Cooperative Research and Development Agreement with the NIH to advance CUTX-101 [7]. - Fortress Biotech, the parent company of Cyprium, is an innovative biopharmaceutical firm with a diverse portfolio, including eight marketed products and multiple development programs across various therapeutic areas [8][9].

Core Insights - Fortress Biotech reported quarterly earnings of $0.11 per share, significantly beating the Zacks Consensus Estimate of a loss of $0.43 per share, marking an earnings surprise of +125.58% [1] - The company posted revenues of $17.63 million for the quarter ended September 2025, which was 25.55% below the Zacks Consensus Estimate, but an increase from $14.63 million year-over-year [2] - Fortress Biotech shares have increased approximately 23% since the beginning of the year, outperforming the S&P 500's gain of 14.6% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.49 on revenues of $27.49 million, while for the current fiscal year, the estimate is -$1.18 on revenues of $80.7 million [7] - The estimate revisions trend for Fortress Biotech was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Fortress Biotech belongs, is currently ranked in the top 36% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]