First patient dosed in Phase 1/2a study with novel immune rejuvenator, a trispecific antibody-fusion protein Two MDX2004 abstracts accepted for poster presentation at SITC Annual Meeting 2025 WESTON, Mass., Oct. 28, 2025 (GLOBE NEWSWIRE) -- ModeX Therapeutics Inc., an OPKO Health company (NASDAQ: OPK), today announced the initiation and recent dosing of the first patient in a Phase 1/2a clinical trial (NCT07110584) with MDX2004, a first-in-class trispecific antibody-fusion protein for oncology and immune ...

Key Takeaways OPKO Health's RAYALDEE remains its leading U.S. renal therapy, driving recent revenue growth.Partnerships with Entera Bio and asset sales to Labcorp aim to streamline operations.ModeX pipeline advances with EBV vaccine and antibody programs progressing in trials.OPKO Health, Inc. (OPK) is well-poised for growth in the coming quarters, courtesy of its potential in RAYALDEE. The optimism surrounding the stock is backed by RAYALDEE’s performance and strategic partnerships. However, stiff competit ...

Core Insights - OPKO Health, Inc. reported its business highlights and financial results for Q2 2025, indicating ongoing advancements in its clinical trials and product development [1][5]. Business Highlights - Merck is advancing a Phase 1 trial for an Epstein-Barr virus vaccine in collaboration with OPKO, evaluating safety and tolerability in 200 healthy adults [1]. - ModeX is progressing its immuno-oncology and immunology portfolio, with multiple clinical candidates, including MDX2001, which is in Phase 1 trials [1]. - OPKO presented promising preclinical data for OPK-88006, a dual agonist for treating metabolic disorders, showing superior therapeutic benefits compared to competitors [1]. - The FDA approved a supplemental application for the 4KScore® Test, allowing it to be performed without digital rectal examination information, enhancing its accessibility for prostate cancer assessment [1]. Financial Results - Total revenues for Q2 2025 were $156.8 million, down from $182.2 million in Q2 2024, with a net loss of $148.4 million, or $0.19 per share, compared to a net loss of $10.3 million, or $0.01 per share, in the prior year [5][13]. - Revenue from product sales was $40.7 million, slightly up from $40.5 million in Q2 2024, while revenue from services decreased to $101.1 million from $129.4 million [5][13]. - The company authorized an additional $100 million for its stock repurchase program, bringing the total capacity to $200 million, representing approximately 14% of OPKO's common shares outstanding [2]. Cash and Assets - As of June 30, 2025, OPKO had cash, cash equivalents, and restricted cash totaling $285.4 million [5]. - The company completed an exchange agreement to purchase $159.2 million of outstanding convertible notes for shares and cash [5].