OPKO Health and Entera Bio announced an expansion of their 2025 Collaboration and License Agreement to advance a once‑daily oral long‑acting parathyroid hormone (PTH) analog for patients with hypoparathyroidism. The new arrangement gives each company a 50% pro‑rata ownership interest in the LA‑PTH program and requires them to share 50% of the development costs. The companies plan to file an investigational new drug (IND) application with the U.S. Food and Drug Administration in late 2026, following favorable pharmacodynamic and pharmacokinetic data reported in December 2025.
The partnership represents a strategic pivot for OPKO, which has historically focused on its ModeX antibody platform. By adding a rare‑disease indication to its pipeline, OPKO diversifies its product portfolio and opens a new revenue stream that could be substantial once the therapy receives approval. The oral tablet format also aligns with OPKO’s broader goal of delivering differentiated, peptide‑based medicines that improve patient convenience and adherence.
For Entera, the collaboration leverages OPKO’s long‑acting peptide chemistry to accelerate the development of a first‑in‑class oral therapy. Entera’s N‑Tab® platform has already demonstrated proof‑of‑concept for oral PTH tablets, and this third program that combines the two companies’ technologies underscores the viability of the platform. Entera’s financial profile—characterized by low revenue, ongoing losses, and significant cash burn—makes the partnership a critical source of capital and expertise to move the program forward.
The governance change accompanying the expansion saw Steve Rubin, OPKO’s Executive Vice President of Administration, join Entera’s board of directors on February 1 2026, replacing former board member Gerry Ostrov. Rubin’s appointment signals the strategic importance of the oral PTH program to both companies and provides Entera with senior leadership experience in drug development oversight.
Management emphasized the program’s potential to transform hypoparathyroidism treatment. “The preclinical data of oral LA‑PTH suggest that this program holds the potential to transform the hypoparathyroidism landscape,” said Miranda Toledano, CEO of Entera. “By combining OPKO’s long‑acting peptide expertise with our N‑Tab® platform, we can deliver a once‑daily oral tablet that could replace the current daily injection therapy.” Phillip Frost, Chairman and CEO of OPKO Health, added, “Expanding our collaboration with Entera to advance this promising long‑acting PTH program aligns with our strategy to develop differentiated, peptide‑based medicines and expands our reach into a rare‑disease market.”
The only approved PTH replacement therapy, Ascendis Pharma’s YORVIPATH, requires daily injections. An oral, once‑daily tablet would offer a significant convenience advantage, potentially improving adherence and quality of life for patients. The partnership’s focus on a rare disease also positions both companies to capture a niche market with limited competition, while the shared ownership and cost structure mitigates financial risk for each party.
The IND filing in late 2026 is a critical milestone that will allow the program to enter clinical trials in the United States. The decision to file follows the December 2025 data that demonstrated favorable pharmacodynamics and pharmacokinetics, providing a strong scientific foundation for the next development phase.
The collaboration also reflects a broader industry trend toward oral peptide therapeutics, a field that has historically been dominated by injectable products. By successfully delivering an oral PTH analog, OPKO and Entera could set a precedent for other peptide indications, potentially opening new markets and revenue streams for both companies.
The partnership’s expansion, governance change, and clear development timeline collectively signal a significant strategic move for both OPKO and Entera, underscoring their commitment to advancing innovative therapies in rare‑disease markets.
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