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
Portfolio Pulse from Happy Mohamed
Entera Bio Ltd. (NASDAQ:ENTX) announced the FDA's plan to rule within 10 months on using bone mineral density (BMD) as a surrogate endpoint for osteoporosis drug trials. This decision could benefit Entera's EB613, a first-in-class oral treatment for osteoporosis, currently in Phase 3, designed to meet the BMD thresholds proposed by the SABRE project. The approval of BMD as a surrogate endpoint could streamline the approval process for new osteoporosis treatments, addressing a significant treatment gap in a disease affecting over 200 million women globally.
March 26, 2024 | 12:33 pm
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Entera Bio's EB613, an oral treatment for osteoporosis, could significantly benefit from the FDA's potential approval of BMD as a surrogate endpoint, streamlining its path to market.
The FDA's consideration to qualify BMD as a surrogate endpoint directly impacts Entera Bio's EB613, as it is designed to meet these BMD thresholds. Approval would likely reduce the time and cost associated with bringing EB613 to market, addressing a significant unmet need in osteoporosis treatment. Given the positive Phase 2 results and the strategic alignment with FDA's potential new regulatory pathway, this news could positively influence investor sentiment and the perceived value of Entera Bio in the short term.
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