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Noticias de FBIO
Eventos de FBIO
Fortress Biotech Sells Rare Pediatric Disease Priority Review Voucher for $205M
Fortress Biotech 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, 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 $129M 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 transaction is subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott Rodino Antitrust Improvements Act.
Fortress Biotech's ZYCUBO Approved by FDA for Pediatric Menkes Disease
Fortress Biotech (FBIO) and its majority-owned subsidiary, Cyprium Therapeutics, announced that the U.S. Food and Drug Administration has approved ZYCUBO for the treatment of Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. A Rare Pediatric Disease Priority Review Voucher was issued in connection with FDA approval and, pursuant to the transaction with Sentynl, will be transferred to Cyprium. Cyprium is also eligible to receive tiered royalties on net sales of ZYCUBO and up to $129M in aggregate development and sales milestones from Sentynl.
Latest Data Shows Sealsq Corp Borrow Rate at 59.18%
Latest data shows the largest indicative borrow rate increases among liquid option names include: DEFIANCE DAILY TARGET 2X LONG RIOT ETF (RIOX) 32.14% +3.09, ProShares UltraShort Lehman 20 plus Year Treasury (TBT) 11.47% +1.29, Valkyrie Bitcoin Miners ETF (WGMI) 13.54% +0.98, Sealsq Corp (LAES) 59.18% +0.93, Ecopetrol (EC) 7.94% +0.63, Outlook Therapeutics Inc (OTLK) 180.99% +0.54, Kodiak AI, Inc. Common Stock (KDK) 46.18% +0.39, Fortress Biotech (FBIO) 24.03% +0.33, Industrial Sector SPDR ETF (XLI) 0.56% +0.31, and Defiance Daily Target 2X Long HIMS ETF (HIMZ) 26.39% +0.30.
Fortress Biotech Files to Sell 600,000 Shares of Common Stock
Fortress Biotech files to sell 600,000 shares of common stock for holders
Fortress Biotech's CUTX-101 New Drug Application Accepted by FDA
Fortress Biotech and its majority-owned subsidiary, Cyprium Therapeutics announced that the U.S. Food and Drug Administration has accepted the resubmission of the New Drug Application for CUTX-101, intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission and as a result, the new Prescription Drug User Fee Act target action date for the NDA is January 14, 2026. In December 2023, Sentynl Therapeutics assumed full responsibility for the development and commercialization of CUTX-101 from Cyprium. On November 14, 2025, Sentynl resubmitted the revised NDA after receiving a complete response letter from the FDA on September 30, 2025, which CRL cited observations regarding the manufacturing site's cGMP compliance. The CRL did not cite any other approvability concerns, nor did it identify any deficiencies in CUTX-101's efficacy and safety data, which demonstrate significant improvement in overall survival for Menkes disease subjects who received early treatment with the therapy. Pursuant to the transaction with Sentynl, Sentynl will transfer to Cyprium, if issued upon approval, a Rare Pediatric Disease Priority Review Voucher, and Cyprium will also be eligible to receive royalties on net sales of CUTX-101 and up to $129M in aggregate development and sales milestones from Sentynl. The CUTX-101 NDA was initially granted Priority Review by the FDA and is supported by positive topline clinical efficacy results for CUTX-101, demonstrating significant improvement in overall survival for Menkes disease subjects who received early treatment with CUTX-101.
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