FDA Qualifies Total Hip BMD as Regulatory Endpoint for Entera Bio's Osteoporosis Drug Development

Reuters12-23 21:30

FDA Qualifies Total Hip BMD as Regulatory Endpoint for Entera Bio's Osteoporosis Drug Development

Entera Bio Ltd. announced the FDA’s broad qualification of total hip bone mineral density (BMD) as a validated regulatory endpoint for novel osteoporosis drugs, marking a significant advancement for osteoporosis innovation. The FDA’s decision, influenced by advocacy from Entera Bio and the FNIH-ASBMR-SABRE team, enables a streamlined regulatory pathway for new treatments. In July 2025, Entera Bio became the first company to receive FDA alignment that a single Phase 3 study using total hip BMD as the primary endpoint would support a New Drug Application (NDA) for its leading candidate, EB613. This regulatory milestone is expected to accelerate drug development and improve access to novel osteoporosis therapies.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Entera Bio Ltd. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 1001156444) on December 23, 2025, and is solely responsible for the information contained therein.

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