Opko Health and Entera Bio Split 50/50 on Oral PTH Program, IND Due Late 2026
Opko Health and Entera Bio expand their partnership on an oral long-acting PTH analog for hypoparathyroidism, agreeing to equal 50% ownership and cost-sharing of the program. They plan to accelerate development and aim to file an IND application with the FDA in late 2026.
1. Partnership Expansion Details
On February 4, Opko Health and Entera Bio agreed to broaden their collaboration to advance an oral long-acting PTH analog (LA-PTH) for hypoparathyroidism as a once-daily tablet, targeting improved patient compliance and therapeutic outcomes.
2. Ownership and Cost Sharing
Under the expanded deal, both companies will hold 50% pro rata ownership of the LA-PTH program and share all development expenses equally, while maintaining the existing 60/40 cost and ownership split on their oral OXM metabolic and fibrotic disorders program.
3. Regulatory and Development Timeline
The partners will accelerate clinical development activities with the goal of submitting an Investigational New Drug application to the FDA in late 2026, positioning the therapy for potential Phase 1 trials thereafter.