JERUSALEM, March 26, 2024 (GLOBE NEWSWIRE) — Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of orally delivered peptides, announced today that The American Society for Bone and Mineral Research (ASBMR) announced on March 25 2024 that the U.S. Food and Drug Administration (FDA) has communicated to the SABRE (Study to Advance BMD as a Regulatory Endpoint) project team that a ruling to qualify the treatment-related change in bone mineral density (BMD) as a surrogate endpoint for fractures in future trials of new anti-osteoporosis drugs would be provided within 10 months.
Entera Bio Announces Key Regulatory Milestone for Oral PTH(1-34) Peptide (EB613) Phase 3 Program: FDA Ruling on Qualifying BMD as a Surrogate Endpoint for Osteoporosis Drugs is Expected Within 10 Months
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