Opko Health and Entera Bio Deepen Alliance on Oral Hormone Therapy

Opko Health and Entera Bio have expanded their collaboration, intensifying efforts to develop an oral tablet for hypoparathyroidism. The core ambition of the partnership is to replace daily injections with a once-daily pill, a shift that could redefine the standard of care for hormone deficiency disorders.

Key Details of the Enhanced Agreement:
* Equal Partnership: The companies will now share development, costs, and future profits on a 50/50 basis.
* Regulatory Path: An Investigational New Drug (IND) application with the U.S. FDA is targeted for late 2026.
* Combined Expertise: The work leverages Entera Bio's N-Tab oral delivery platform integrated with Opko's protein research capabilities.

The revised agreement, announced two days ago, grants both firms equal ownership of the LA-PTH program. This move follows encouraging pharmacological data released in December 2025, which supported advancing the treatment into clinical trials. The collaboration is structured to jointly shoulder both the financial burden and the potential rewards.

A significant technical challenge lies at the heart of the project: enabling the oral delivery of peptide drugs, which are typically broken down in the digestive system. The partners are employing a specialized platform designed to make these biological molecules available orally. The LA-PTH initiative represents the third project to utilize this joint technology, aiming to offer patients a more convenient alternative to injections and potentially greatly improving treatment adherence.

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Broader Pipeline and Strengthened Ties

Beyond the hypoparathyroidism program, the alliance is also progressing a separate project targeting metabolic and fibrotic diseases using Oxyntomodulin. Initial data from a Phase 1 study for an injectable version of this therapy are anticipated by the end of 2026, with work on an oral formulation planned to follow.

The strengthened partnership is further signaled by a key personnel change. Steve Rubin, Executive Vice President at Opko Health, is joining the board of directors at Entera Bio. This interlocking directorship points toward a long-term strategic commitment between the two entities.

For the investment community, attention now turns to forthcoming financials. Opko Health is scheduled to report its fourth quarter and full-year 2025 results on February 26. This disclosure will provide insight into how the company is allocating capital to support its expanded research and development activities in the current year.