The U.S. Food and Drug Administration formally qualified total hip bone mineral density (BMD) as a validated surrogate endpoint for osteoporosis therapies on December 19, 2025, and Entera Bio announced the decision on December 23, 2025. The qualification removes a key regulatory hurdle for the company’s lead product, EB613, an oral parathyroid hormone tablet that could become the first new osteoporosis drug approved since 2019 and the first oral anabolic agent.
With the FDA’s endorsement, Entera can now design a single 24‑month Phase 3 study that uses total hip BMD as the primary endpoint. The streamlined pathway reduces the need for lengthy fracture‑endpoint trials, cutting development time and cost while increasing the probability of a successful New Drug Application. The qualification also strengthens EB613’s appeal to strategic partners, potentially accelerating licensing or collaboration deals before the company’s cash runway—projected to support operations through the third quarter of 2026—runs out.
Entera’s announcement highlighted the broader market opportunity: osteoporosis affects more than 200 million women worldwide, yet no new therapies have entered the market since 2019. The company’s oral formulation offers a convenient alternative to injectable anabolic agents, positioning EB613 to capture a sizable share of the unmet need. The FDA’s decision is part of the larger Study to Advance BMD as a Regulatory Endpoint (SABRE) initiative, which aggregated data from multiple trials to demonstrate the correlation between BMD gains and fracture risk reduction.
CEO Miranda Toledano emphasized the milestone’s significance, noting that the qualification “removes a major regulatory hurdle and confirms the strength of our data.” She added that the approval “opens a clear path for EB613 to become the first oral anabolic therapy for post‑menopausal osteoporosis.” The company’s management also reiterated confidence in its financial position, stating that current cash and cash equivalents are sufficient to fund the Phase 3 program through Q3 2026.
Market reaction to the announcement was strong: the company’s shares rose 6.21% on unusually high volume, reflecting investor enthusiasm for the regulatory breakthrough. Analysts highlighted the qualification as a key driver of the positive reaction, noting that it reduces development risk and enhances the asset’s commercial prospects.
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