OPKO HEALTH, INC.
OPK evidence brief
What we can confirm
What it means
What to watch
Prepared research question
What matters most for OPK—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · OPK
OPKO Health, Inc. is a diversified healthcare company with a pharmaceutical business focused on Rayaldee and NGENLA, and a diagnostics business through its BioReference Laboratories subsidiary. The company has a history of operating losses and relies on commercializing approved products and advancing a pipeline of clinical-stage candidates.
Key risk: History of operating losses
BioSniper Score
Based on 6 of 6 signals
Market Cap
$1.10B
Cash Runway
25.5 moLead Asset
mdx2001 (Phase 1/Phase 2)
Next Catalyst
Patent_Expiry · Mar 14, 2034Financial data as of Jun 30, 2026.
Tracking 9 pipeline candidates · 9 clinical trials · 1 catalyst for OPKO HEALTH, INC..
OPKO Health, Inc. is a diversified healthcare company with a pharmaceutical business focused on Rayaldee and NGENLA, and a diagnostics business through its BioReference Laboratories subsidiary. The company has a history of operating losses and relies on commercializing approved products and advancing a pipeline of clinical-stage candidates.
- OPKO Health has a pharmaceutical business that markets Rayaldee and NGENLA, and a diagnostics business through BioReference Laboratories [sec_mda · as of 2026-02-26].
- As of June 30, 2026, the company reported cash & equivalents of $314.4M, total revenue of $163.6M, and a net loss of -$8.4M [sec].
- The company has a history of operating losses; other than fiscal years 2020 and 2021, consolidated operations have not historically been profitable [sec_mda · as of 2026-02-26].
- OPKO has several clinical-stage programs, including a Phase 2 study of MDX2001 (NCT06239194) and a completed Phase 3 study of MOD-4 (NCT02968004) [catalyst].
- The company faces risks related to its ability to generate sustained profits, secure additional funding, and successfully commercialize its approved products [sec_mda · as of 2026-02-26].
What works
- OPKO has a diversified business model with both pharmaceutical and diagnostics operations, which may provide multiple revenue streams [sec_mda · as of 2026-02-26].
- The company has a pipeline of clinical-stage candidates, including MDX2001 in a Phase 1/2a trial, indicating ongoing R&D investment [catalyst].
- OPKO holds approved products (Rayaldee, NGENLA) that are already generating revenue, providing a commercial foundation [sec_mda · as of 2026-02-26].
What to weigh
- OPKO has a history of operating losses and has not generated sustained positive cash flow from operations, except during the COVID-19 testing period [sec_mda · as of 2026-02-26].
- The company may require additional funding, which may not be available on acceptable terms, and could lead to dilution or restrictive covenants [sec_mda · as of 2026-02-26].
- Commercial success of Rayaldee and NGENLA is not guaranteed, and failure to achieve market acceptance could limit revenue generation [sec_mda · as of 2026-02-26].
- Clinical trials may be delayed or fail due to patient enrollment, safety issues, or lack of efficacy, and positive early results may not predict later-stage success [sec_mda · as of 2026-02-26].
From the filings
Quoted directly from source documents.
OPKO has a history of operating losses and may not achieve profitability.
“We have had a history of operating losses and may not be able to achieve profitability in the near future.”
SEC MD&A · February 26, 2026
The company's pharmaceutical business has historically generated only limited revenue.
“Our pharmaceutical business has historically generated only limited revenue from operations and we may not generate substantial revenue from the sale of proprietary pharmaceutical pro”
SEC MD&A · February 26, 2026
OPKO may need additional funding, which may not be available on acceptable terms.
“We may require additional funding, which may not be available to us on acceptable terms, or at all.”
SEC MD&A · February 26, 2026
Clinical trial results may not satisfy regulatory requirements.
“The results of pre-clinical trials and previous clinical trials for our products may not be predictive of future results, and our current and planned clinical trials may not satisfy the requirements of the FDA or other non-U.S. regulatory authorities.”
SEC MD&A · February 26, 2026
Catalyst timeline
- 2034-03-14 · Patent_Expiry · RAYALDEE — The patent/exclusivity for RAYALDEE is set to expire, which could impact future revenue from the product.
Risks & what to watch (4)›
Key risks
- History of operating losses — OPKO has not been profitable except during COVID-19 testing years; sustained profitability is uncertain [sec_mda · as of 2026-02-26].
- Dependence on Rayaldee and NGENLA — If these products fail to achieve market acceptance, the company may not generate substantial revenue [sec_mda · as of 2026-02-26].
- Need for additional funding — OPKO may require capital that is not available on acceptable terms, potentially leading to dilution or business curtailment [sec_mda · as of 2026-02-26].
- Clinical trial delays or failures — Trials may be delayed by slow enrollment, safety issues, or lack of efficacy; positive early results may not predict later success [sec_mda · as of 2026-02-26].
What to watch
- Commercial performance of Rayaldee and NGENLA, as revenue from these products is critical to the company's pharmaceutical business [sec_mda · as of 2026-02-26].
- Progress of the Phase 1/2a trial for MDX2001 (NCT06239194), which is a key pipeline asset [catalyst].
- The company's ability to achieve sustained profitability and positive cash flow from operations [sec_mda · as of 2026-02-26].
- Any need for additional financing and the terms under which it may be obtained [sec_mda · as of 2026-02-26].
Sources: Catalysts · SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 6 of 6 signals · derived from public data
25.5 months
D/E 0.54 · 0% dilution
Lead: Approved
9 candidates
1 upcoming, next in ~2753d
1 buy · 0 sells (180d)
Runway
Catalysts
Pipeline
Regulatory
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
231
Total value held
$179.4M
| Holder | Shares | Value |
|---|---|---|
| blackrock, inc. | 36,232,223 | $41.3M |
| vanguard capital management llc | 28,998,328 | $33.1M |
| vanguard portfolio management llc | 14,769,719 | $16.8M |
| geode capital management, llc | 11,301,501 | $12.9M |
| state street corp | 9,501,377 | $10.8M |
| goldman sachs group inc | 7,675,026 | $8.7M |
| northern trust corp | 3,619,346 | $4.1M |
| charles schwab investment management inc | 3,574,039 | $4.1M |
| vanguard fiduciary trust co | 2,742,017 | $3.1M |
| op asset management ltd | 2,204,508 | $2.7M |
Showing top 10 of 231 institutional holders of OPKO HEALTH, INC.. Open the full 13F history after sign-in.
Short Interest
as of Apr 20, 2026- % of float
- 7.8%
- Days to cover
- 12.7
- Shares short
- 33,615,361
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
OPK short interestGovernance
Frequently asked questions
What is the AI investment thesis for OPKO HEALTH, INC.?
OPKO Health, Inc. is a diversified healthcare company with a pharmaceutical business focused on Rayaldee and NGENLA, and a diagnostics business through its BioReference Laboratories subsidiary. The company has a history of operating losses and relies on commercializing approved products and advancing a pipeline of clinical-stage candidates.
What is OPKO HEALTH, INC.'s lead drug candidate?
OPKO HEALTH, INC.'s most advanced tracked candidate is mdx2001 (Phase 1/Phase 2) for solid tumors.
What is OPKO HEALTH, INC.'s next catalyst?
OPKO HEALTH, INC.'s next tracked catalyst is a Patent_Expiry event — "Patent/Exclusivity Expiry: RAYALDEE" — expected March 14, 2034.
Who is the CEO of OPKO HEALTH, INC.?
Dr. Phillip Frost M.D., Ph.D. is the chief executive officer of OPKO HEALTH, INC. (OPK).
Where is OPKO HEALTH, INC. headquartered?
OPKO HEALTH, INC. (OPK) is headquartered in Miami, FL, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.