Preclinical Data for OPKO Biologics' OPK8801001 in Acromegaly Presented at ENDO 2026
Rhea-AI Summary
OPKO Health (NASDAQ:OPK), through OPKO Biologics, presented preclinical data for OPK8801001, a novel long-acting hGH receptor antagonist for acromegaly, at ENDO 2026.
In vivo studies showed robust, dose-dependent, sustained IGF-1 suppression, and in vitro data indicated about 20-fold stronger receptor antagonism than Pegvisomant, suggesting a differentiated, once-weekly treatment candidate that may ease daily therapy burden and supports OPKO’s long-acting protein platform.
Positive
- In vivo data showed robust, dose-dependent, sustained suppression of IGF-1 in acromegaly models
- In vitro growth hormone receptor antagonism about 20-fold greater than Pegvisomant
- Findings suggest potential once-weekly dosing versus currently available daily treatments
- Supports positioning of OPK8801001 as a differentiated treatment candidate for acromegaly
- Data further validate OPKO Biologics’ long-acting protein platform for endocrine conditions
Negative
- Results are based on preclinical in vivo and in vitro data only, with no human trial outcomes reported
News Market Reaction – OPK
In the Jun 15 session, OPK declined 1.41%, reflecting a mild negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 12 | Preclinical data | Positive | -1.8% | ModeX MDX3001 preclinical CAR-T and B-cell depletion data at ASGCT 2026. |
| Apr 30 | Partnership expansion | Positive | +1.4% | Expanded Nicoya deal, 15% equity stake and up to $115M milestones. |
| Apr 30 | Platform launch | Positive | +1.4% | Launch of BioReference Direct consumer diagnostic testing platform. |
| Apr 28 | Earnings results | Negative | -8.3% | Q1 2026 results with $124.2M revenue and $54.8M net loss. |
| Apr 22 | Clinical trial start | Positive | +2.5% | Phase 1 start for MDX2003 tetraspecific T‑cell engager in B‑cell lymphoma. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent pipeline and partnership news has mostly aligned with price moves, while one preclinical update saw a negative reaction.
Over the past few months, OPKO has reported Q1 2026 financials, advanced its ModeX clinical pipeline, expanded its RAYALDEE commercialization in Greater China, and launched the BioReference Direct consumer testing platform. Most of these business development and clinical updates saw price moves aligned with their generally positive tone, while a prior preclinical ModeX data presentation coincided with a modest share decline of about 1.79%.
Key Terms
insulin-like growth factor-1 medical
igf-1 medical
in vivo medical
in vitro medical
growth hormone receptor antagonist medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
MIAMI, June 15, 2026 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) OPKO Biologics, an OPKO Health company, presented preclinical data for OPK8801001 at ENDO 2026, the Endocrine Society’s annual meeting. The poster, “Production and Characterization of OPK8801001, a Novel Long-Acting hGH Receptor Antagonist for the Treatment of Acromegaly,” available here, was presented by Moran Golan, Ph.D., Director of Preclinical & Clinical Pharmacology at OPKO Biologics.
In vivo data showed that OPK8801001 produced robust, dose-dependent, sustained suppression of insulin-like growth factor-1 (IGF-1), a marker of disease activity in acromegaly. The findings suggest the potential for a weekly alternative to currently available daily treatments. In vitro data demonstrated that OPK8801001’s potent growth hormone receptor antagonism is approximately 20-fold greater than Pegvisomant, a current therapy for acromegaly.
“These preclinical findings support the potential of OPK8801001 as a differentiated, once-weekly treatment candidate for acromegaly that could reduce the burden of daily therapy for patients,” said Laura Moschcovich, Ph.D., General Manager of OPKO Biologics. “The data presented at ENDO 2026 further validate our long-acting protein platform and demonstrate our commitment to advancing new treatment options for patients with serious endocrine conditions.”
Acromegaly is a rare endocrine disorder caused by excess growth hormone, usually as the result of a benign tumor in the pituitary gland. The condition leads to elevated levels of IGF-1 and can result in hypertension, diabetes, and cardiovascular disease. Despite available therapies, there remains a need for drugs that provide disease control while easing the demands of ongoing treatment.
About OPKO Biologics
OPKO Biologics is a clinical stage company developing next-generation, bio-better, long-acting versions of therapeutic proteins and peptide drugs candidates, utilizing CTP, reversible PEGylation and stabilizer-based technologies. OPKO Biologics' pipeline includes first in class candidates for endocrinology indications such as hypoparathyroidism (HPT) and Short Bowel Disease (SBS). OPKO Biologics, an OPKO Health company (NASDAQ: OPK), is based in Kiryat Gat, Israel. For more information, visit https://www.opkobiologics.com/
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit www.opko.com.
Cautionary Statement Regarding Forward Looking Statements
This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding product development efforts as well as other non-historical statements about our expectations, products, beliefs or intentions regarding our business, financial condition, strategies or prospects including statements regarding expectations about OPK8801001 including whether the results of preclinical data are reproducible, the safety and efficacy of OPK8801001, whether OPK8801001 will enter clinic and whether clinical data will be positive, whether OPK8801001 could reduce therapy burden, and whether results of any study will support commercialization. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and under the heading “Risk Factors” in our other filings with the Securities and Exchange Commission as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable products and treatments, including the risks that others may develop products which are superior to OPK8801001. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.
Contacts:
Alliance Advisors IR
Vivian Cervantes, 973-873-7724
vcervantes@allianceadvisors.com
