Opko Health, Inc. OPK
Opko Health, Inc. (Nasdaq: OPK) is a cardio-renal-metabolic drug developer. Its lead program, Rayaldee (calcifediol ER), is in Pre-clinical for secondary hyperparathyroidism in CKD stage 3-4 with vitamin D insufficiency.
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 | small molecule | Approved |
| NGENLA (somatrogon) | pediatric growth hormone deficiency (partnered with Pfizer) | protein/peptide | Approved |
| ModeX multispecific antibodies (incl. EBV vaccine licensed to Merck) | oncology/infectious disease | antibody | Pre-clinical |
Recent results and decisions
- Oct 14, 2026n/a OPKO Health's BioReference subsidiary enters agreement to sell clinical and anatomic pathology laboratory testing business, including 4Kscore prostate cancer test, to Laboratory Corporation of America Holdings for $722 million in cash plus up to $150 million in earnouts over 10 years.
Buyer has agreed to pay Seller an aggregate purchase price of $722,000,000 in cash upon closing of the Transaction, subject to certain upward or downward adjustments (if any) based on Business revenues at the closing, plus up to $150,000,000 in cash over a period of up to ten years based on the reve
Filing - Oct 14, 2026n/a OPKO enters into asset purchase agreement to sell BioReference's clinical and anatomic pathology laboratory testing business, including the 4Kscore prostate cancer test, to LabCorp for $722 million in cash plus up to $150 million in revenue-based earnouts.
Buyer has agreed to pay Seller an aggregate purchase price of $722,000,000 in cash upon closing of the Transaction, subject to certain upward or downward adjustments (if any) based on Business revenues at the closing, plus up to $150,000,000 in cash over a period of up to ten years based on the reve
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 pre-clinical cardio-renal-metabolic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.