OPK biotech catalysts & pipeline

OPKO HEALTH INC · Data as of 2026-10-25

Upcoming catalysts

long-acting PTH tablet — IND submission

late 2026

Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in late 2026.

Source filing

MDX2301 — Initial data

Sep 2026–Apr 2027

Initiated MDX2301 Phase 1 clinical trial for the prevention of COVID-19, with plans to complete enrollment in the third quarter 2026 and early data to be presented in late 2026 or early 2027.

Source filing

MDX2004 — Initial data

H1 2027

We expect to report initial safety, tolerability, pharmacokinetic and immune data in the first half of 2027.

Source filing

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