OPKO Health, Inc. OPK
OPKO Health, Inc. (Nasdaq: OPK) is an oncology drug developer. Its lead program, ModeX Phase 3 multispecific antibody program, is in Phase 3 for Oncology and infectious diseases.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Rayaldee | Secondary hyperparathyroidism in CKD | small molecule | Approved |
| NGENLA (somatrogon-ghla) | Growth hormone deficiency | protein/peptide | Approved |
| Mazdutide (Eli Lilly) | Metabolic | protein/peptide | Approved |
| ModeX Phase 3 multispecific antibody program | Oncology and infectious diseases | antibody | Phase 3 |
| EBV vaccine candidate (Merck collaboration) | Epstein-Barr virus | vaccine | Phase 1 |
| ModeX earlier-stage multispecific antibody programs | Oncology and infectious diseases | antibody | Pre-clinical |
| COVID-19 multispecific antibodies (BARDA) | COVID-19 | antibody | Pre-clinical |
| Influenza multispecific protein antibody (BARDA) | Influenza | antibody | Pre-clinical |
Recent results and decisions
- Nov 4, 2026started OPKO Biologics dosed first participant in Phase 1/2a trial of OPK-8801001, a long-acting human growth hormone receptor antagonist for acromegaly.
The first participant has been dosed in a first-in-human Phase 1/2a clinical trial of OPK-8801001, an investigational, long acting human growth hormone receptor antagonist being developed for the treatment of acromegaly.
Filing - Nov 4, 2026completed enrollment ModeX completes enrollment in MDX2301 Phase 1 trial, a tetravalent bispecific antibody for COVID-19 in immunocompromised adults.
ModeX completes enrollment in MDX2301 Phase 1 clinical trial. MDX2301 is a tetravalent bispecific antibody designed to neutralize known SARS-CoV-2 variants while maintaining breadth and reducing the potential for resistance.
Filing - Oct 29, 2025approval FDA approved supplemental application allowing the 4Kscore Test to be performed without digital rectal exam information (July 2025); diagnostic test, not a drug.
In July, the U.S. Food and Drug Administration (FDA) approved OPKO's supplemental application enabling the performance of the 4Kscore®Test without digital rectal examination (DRE) information.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.