OPKO reports Q2 2026 results with multiple pipeline milestones across ModeX and OPKO Biologics

OPKO Health said its ModeX unit presented data on multispecific antibody targeted in vivo CAR T cell programs at the American Society of Gene + Cell Therapy Annual Meeting, with plans to enter Phase 1 studies later this year or in early 2027.¹ The company also said it is working toward starting a company-sponsored Phase 1 study in autoimmune disease around the same late 2026 to early 2027 window, while also exploring possible collaborations with large pharmaceutical partners.¹

OPKO reported it has begun enrolling patients in a Phase 1 trial of MDX2003, a tetraspecific T-cell engager-expander targeting CD19, CD20, CD3 and CD28, in relapsed or refractory B-cell lymphoma.¹ Separately, the company initiated a Phase 1 trial of MDX2301, a COVID-19 prevention candidate, with enrollment expected to finish in the third quarter of 2026 and early data expected in late 2026 or early 2027; the trial is funded by BARDA.¹ Other ModeX programs continue moving forward: MDX2001, targeting Trop2 and c-Met in solid tumors, and MDX2004, a trispecific immune rejuvenator, are both proceeding with Phase 1 enrollment as planned, including sites in Australia and Israel.¹ The company said it expects to report initial safety, tolerability, pharmacokinetic and immune data in the first half of 2027.¹

On the metabolic side, OPKO began a Phase 1/2a study of OPK-88006, a subcutaneous dual GLP-1/glucagon agonist, enrolling healthy and presumed MASH participants in the US.¹ OPKO Biologics also presented preclinical data on its long-acting Growth Hormone Receptor Antagonist OPK8801001 at the Endocrine Society 2026 meeting, with plans to enter clinical trials by the end of 2026.¹

On the commercial side, OPKO expanded its Nicoya agreement for Rayaldee in Greater China, receiving a 15% equity stake in Nicoya, with up to $115 million in potential milestones unchanged from the original deal.¹

Financially, cash, cash equivalents, marketable securities and restricted cash totaled $314.4 million as of June 30, 2026.¹ The company also provided third-quarter and full-year 2026 revenue and expense guidance in the release.