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 ...

Core Viewpoint - Momentum investing focuses on "buying high and selling higher" rather than traditional strategies of "buying low and selling high" [1][2] Group 1: Momentum Investing Strategy - Momentum investors often face challenges in determining the right entry point, as stocks may lose momentum when their valuations exceed future growth potential [2] - A safer approach involves investing in bargain stocks that exhibit recent price momentum, utilizing tools like the Zacks Momentum Style Score to identify such opportunities [3] Group 2: Fortress Biotech (FBIO) Analysis - Fortress Biotech (FBIO) has shown a four-week price change of 6.3%, indicating growing investor interest [4] - Over the past 12 weeks, FBIO's stock has gained 12.8%, with a beta of 1.81, suggesting it moves 81% more than the market [5] - FBIO has a Momentum Score of B, indicating a favorable time to invest based on momentum [6] - The stock has a Zacks Rank 2 (Buy) due to upward revisions in earnings estimates, which typically attract more investors [7] - FBIO is trading at a Price-to-Sales ratio of 0.56, suggesting it is undervalued at 56 cents for each dollar of sales [7] Group 3: Additional Investment Opportunities - Besides FBIO, there are other stocks that meet the criteria of the 'Fast-Paced Momentum at a Bargain' screen, presenting further investment opportunities [8] - Zacks offers over 45 Premium Screens tailored to different investing styles, aiding in the identification of potential winning stocks [9]

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 ...

A safer approach could be investing in bargain stocks with recent price momentum. While the Zacks Momentum Style Score (part of the Zacks Style Scores system) helps identify great momentum stocks by paying close attention to trends in a stock's price or earnings, our 'Fast-Paced Momentum at a Bargain' screen comes handy in spotting fast-moving stocks that are still attractively priced. While any stock can see a spike in price for a short period, it takes a real momentum player to deliver positive returns fo ...

Core Points - Mustang Bio, Inc. has completed a registered direct offering of 6,130,000 shares of common stock at a price of $0.41 per share, generating approximately $2.5 million in gross proceeds [1][2] - The company intends to use the net proceeds for working capital and general corporate purposes [2] - In a concurrent private placement, Mustang issued unregistered warrants to purchase an additional 6,130,000 shares at the same exercise price of $0.41 per share [1][3] Offering Details - The offering was conducted under Nasdaq rules and the shares were sold at-the-market [1] - The unregistered warrants are exercisable upon stockholder approval and will expire five years from that date [1] - H.C. Wainwright & Co. acted as the exclusive placement agent for the offering [7] Company Overview - Mustang Bio is a clinical-stage biopharmaceutical company focused on developing cell therapies for difficult-to-treat cancers [10] - The company aims to acquire rights to medical technologies through licensing or ownership, fund research and development, and bring these technologies to market [10] - Mustang has partnered with leading medical institutions to advance CAR-T therapy development [10]