Core Insights - The FDA has granted a six-month priority review for CUTX-101, a potential first treatment for Menkes disease, with a target action date of June 30, 2025 [1][3] - CUTX-101 has shown promising clinical efficacy, with nearly 80% reduction in the risk of death for patients receiving early treatment compared to untreated controls [2][6] - Menkes disease is a rare and fatal pediatric condition with a prevalence estimated between 1 in 34,810 to 1 in 8,664 live male births [1][8] Company Overview - Sentynl Therapeutics, a biopharmaceutical company focused on rare diseases, is responsible for the development and commercialization of CUTX-101 [4][9] - The company was acquired by Zydus Group in 2017 and aims to address unmet medical needs through innovative therapies [9][10] - Fortress Biotech, which previously advanced the CUTX-101 program, continues to support its development [5][11] Product Details - CUTX-101 is a subcutaneous injectable formulation of copper histidinate, designed to improve tolerability and enhance neurodevelopmental outcomes in Menkes disease patients [6][7] - The drug has received multiple FDA designations, including Breakthrough Therapy and Orphan Drug Designation, indicating its potential significance in treating this condition [3][6] Market Context - There are currently no FDA-approved treatments for Menkes disease, highlighting a significant unmet need in the pediatric healthcare market [8][12] - The ongoing clinical trials and positive results for CUTX-101 may position it as a critical therapeutic option for affected children and their families [2][5]

Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025 Cyprium is eligible to receive royalties and up to $129 million in aggregate development and sales milestones Cyprium also retains ownership over any Priority Review Voucher that may be issued at NDA approval MIAMI, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced the acceptance for review of th ...

Emrosi approved by FDA on November 4 for the treatment of inflammatory lesions of rosacea in adults Cosibelimab PDUFA goal date of December 28 for potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma MIAMI, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividen ...

MIAMI, Sept. 26, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress"), 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 revenue, today announced that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in the following upcoming October 2024 investor conferences: Lytham Partners Fall 2024 Investor Confer ...

MIAMI, Sept. 20, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) ("Fortress" or "Company"), 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 revenue, today announced that on September 19, 2024 it entered into securities purchase agreements with healthcare focused institutional investors for the issuance and sale of 3,939,394 shares of its common stock ...

Fortress Biotech (FBIO) came out with a quarterly loss of $0.73 per share versus the Zacks Consensus Estimate of a loss of $1.32. This compares to loss of $3.60 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of 44.70%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $2.03 per share when it actually produced a loss of $1.03, delivering a surprise of 49.26%. Over the last four quarters, the ...

Aman Kumar, Co-Portfolio Manager for Oaktree's Life Sciences Lending platform, commented, "We are delighted to continue our strategic partnership with Fortress, supporting their ability to source, acquire and develop innovative assets with strong proof-of-concept in humans and the potential to address areas of high unmet medical need. Fortress has several near-term value creating opportunities across its extensive pipeline, along with a unique and highly scalable business model. We are impressed by the Comp ...

WORCESTER, Mass., June 21, 2024 (GLOBE NEWSWIRE) -- Mustang Bio, Inc. ("Mustang" or the "Company") (Nasdaq: MBIO), a clinical-stage biopharmaceutical company focused on translating today's medical breakthroughs in cell therapies into potential cures for difficult-to-treat cancers, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules, for the issuance and sale of an aggregate of 6,130,000 of its shares of common stock (or common stock equi ...

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering. The gross proceeds to Mustang from the offering are expected to be approximately $2.5 million, before deducting the placement agent's fees and other offering expenses payable by the Company. Mustang currently intends to use the net proceeds from the offering for working capital and general corporate purposes. The offer and sale of the unregistered warrants in the private placement are being made in a transaction not involving ...

All patients were heavily pretreated/refractory to BTK inhibitors, and only one patient has started new anti-WM treatment after MB-106 Overall response rate of 90% in cohort with durable responses observed; one patient remains in complete remission at 31 months Outpatient administration was allowed and found to be feasible Currently no FDA-approved CAR-T treatments for WM Data presented at the European Hematology Association 2024 Hybrid Congress WORCESTER, Mass., June 17, 2024 (GLOBE NEWSWIRE) -- Mustang Bi ...