Entera Bio Ltd. reported that the American Society for Bone and Mineral Research (ASBMR) has announced that the SABRE (Strategy to Advance BMD as a Regulatory Endpoint) project team has submitted to the U.S. Food and Drug Administration (FDA) its full qualification plan to use the treatment- related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs. BMD is the first surrogate endpoint undergoing qualification by the FDA under the 21st Century Cures Act which was signed into law on December 13, 2016, to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. In October 2022, following a Type C meeting, Entera announced FDA's concurrence that a 2-year, placebo- controlled phase 3 (registrational) study with Total Hip BMD as primary endpoint could support an NDA for EB613.