MIAMI, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, today announced that Crystalys Therapeutics, Inc. (“Crystalys”), in which Urica maintains an equity position, dosed first patients in its two randomized, double-blind, multicenter global Phase 3 trials, the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888), evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potenti ...

MIAMI, Oct. 21, 2025 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, today announced that Crystalys Therapeutics, Inc. (“Crystalys”), in which Urica maintains an equity position, dosed first patients in its two randomized, double-blind, multicenter global Phase 3 trials, the RUBY study (NCT07089875) and the TOPAZ study (NCT07089888), evaluating dotinurad, a next-generation, once daily oral, URAT1 inhibitor with potenti ...

, /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Fortress Biotech Inc. ("Fortress" or the "Company") (NASDAQ: FBIO). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980. The investigation concerns whether Fortress and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] CONTACT: Danielle Peyton Pomerantz ...

LOS ANGELES, Oct. 01, 2025 (GLOBE NEWSWIRE) -- The Portnoy Law Firm advises Fortress Biotech Inc., ("Slide" or the "Company") (NASDAQ: FBIO) investors that the firm has initiated an investigation into possible securities fraud, and may file a class action on behalf of investors.  Investors are encouraged to contact attorney Lesley F. Portnoy, by phone 844-767-8529 or email: lesley@portnoylaw.com, to discuss their legal rights, or join the case via https://portnoylaw.com/fortress-biotech-inc. The Portnoy Law ...

ATLANTA, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Fortress Biotech, Inc. (“Fortress” or the “Company”) (NASDAQ: FBIO) complied with federal securities laws. On October 1, 2025, Fortress and its subsidiary, Cyprium Therapeutics, Inc., announced that the FDA issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 and that the “CRL noted cGMP deficiencies had been observed at the facility where CUTX-101 is manufactured.”  Follow ...

Dotinurad is a next-generation URAT1 inhibitor in two Phase 3 clinical trials with potential for best-in-class safety and efficacy Urica sold dotinurad to Crystalys Therapeutics in 2024 in exchange for equity and a 3% royalty on future net sales of dotinurad MIAMI, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Urica Therapeutics, Inc. (“Urica” or the “Company”), a Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) subsidiary, today announced that Crystalys Therapeutics, Inc. (“Crystalys”), in which Urica maintains an ...

Core Insights - Premarket trading is showing notable activity with early price movements indicating potential opportunities before the market opens [1] Premarket Gainers - Galaxy Payroll Group Limited (GLXG) increased by 39% to $5.34 - Lithium Americas Corp. (LAC) rose by 31% to $7.52 - Senmiao Technology Limited (AIHS) gained 22% to $2.45 - The AES Corporation (AES) saw a 10% increase to $14.53 - Strive, Inc. (ASST) also increased by 10% to $2.77 - Shoulder Innovations, Inc. (SI) rose by 9% to $13.78 - Top KingWin Ltd (WAI) increased by 8% to $3.80 - Southland Holdings, Inc. (SLND) saw a 7% increase to $4.61 - CaliberCos Inc. (CWD) rose by 6% to $4.75 - Mannatech, Incorporated (MTEX) increased by 5% to $10.53 [3] Premarket Losers - Real Messenger Corporation (RMSG) decreased by 16% to $2.01 - Etoiles Capital Group Co., Ltd (EFTY) fell by 14% to $14.45 - Enanta Pharmaceuticals, Inc. (ENTA) dropped by 13% to $10.41 - CollPlant Biotechnologies Ltd. (CLGN) saw an 11% decrease to $2.39 - Fortress Biotech, Inc. (FBIO) declined by 10% to $3.30 - Uni-Fuels Holdings Limited (UFG) fell by 9% to $7.52 - Alset Inc. (AEI) decreased by 9% to $2.30 - JFB Construction Holdings (JFB) saw a 5% decline to $12.20 - SHF Holdings, Inc. (SHFS) dropped by 5% to $6.80 - Phio Pharmaceuticals Corp. (PHIO) decreased by 5% to $2.34 [4]

MIAMI, Oct. 01, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a Complete Response Letter (“CRL”) relating to the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. In December 2023, Sentynl Therapeutics, Inc. (“Sentynl”), a U.S.-based biopharmaceutical company ...

Company Highlights - Aurinia Pharmaceuticals Inc. (AUPH) has seen solid growth for its product LUPKYNIS, with expected net product sales for 2025 ranging from $250 million to $260 million, up from $216.2 million last year [2][3] - Arrowhead Pharmaceuticals Inc. (ARWR) is preparing for its first commercial launch in 2025, with its lead drug candidate Plozasiran under FDA review, decision expected on November 18, 2025 [4][5] - Beta Bionics Inc. (BBNX) reported a 54% growth in second-quarter net sales, with expectations for full-year 2025 net sales to range between $88 million and $93 million, compared to $65.1 million last year [7][8] - Kiniksa Pharmaceuticals International plc (KNSA) anticipates net product revenue for its drug Arcalyst to be between $625 million and $640 million for 2025, up from $417 million in 2024 [10][11] - Ionis Pharmaceuticals Inc. (IONS) generated net product sales of $19 million in Q2 2025, with a supplemental new drug application expected by year-end [12][14] - Stoke Therapeutics Inc. (STOK) is developing Zorevunersen for Dravet syndrome, with a 52-week high of $24.60 reached recently, representing an 82% gain in less than two months [16][17] - Fortress Biotech Inc. (FBIO) is awaiting an FDA decision on its investigational drug CUTX-101 for Menkes disease, expected on September 30, 2025 [18][21] Stock Performance - AUPH stock increased by 168% over 1.5 years, reaching a 52-week high of $12.87 [3] - ARWR stock gained 65% in less than 9 months, hitting a 52-week high of $31.13 [5] - BBNX stock rose nearly 55% in less than 4 months, reaching a 52-week high of $26.66 [8] - KNSA stock saw a 46% increase in less than four months, touching a 52-week high of $37.34 [11] - IONS stock gained 52% in less than two months, reaching a 52-week high of $64.72 [15] - STOK stock increased by 82% in less than two months, achieving a 52-week high of $24.60 [17] - FBIO stock rose by 61% in less than a month, reaching a 52-week high of $3.97 [21]

Company Overview - Fortress Biotech, Inc. 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 [2] - The company has eight marketed prescription pharmaceutical products and multiple programs in development across various therapeutic areas including oncology, dermatology, and rare diseases [2] - Fortress leverages its significant biopharmaceutical industry expertise and network to expand and advance its portfolio of product opportunities [2] Partnerships and Collaborations - Fortress has established partnerships with leading academic research institutions and biopharmaceutical companies, including AstraZeneca, City of Hope, Fred Hutchinson Cancer Center, Nationwide Children's Hospital, Columbia University, Dana Farber Cancer Center, and Sentynl Therapeutics [2] Upcoming Events - Lindsay A. Rosenwald, M.D., Chairman, President, and CEO of Fortress, will present a corporate overview at the H.C. Wainwright 27th Annual Global Investment Conference, with the presentation available for on-demand viewing starting September 5, 2025 [1] - The company will also participate in virtual one-on-one meetings during the conference from September 8-11, 2025 [1]