Why Entera Bio Shares Are Trading Higher Today - Entera Bio (NASDAQ:ENTX)

Following its End of Phase 2 Meeting with the FDA, Entera Bio Ltd ENTX has designed the pivotal study for EB613 as an 18-month double-blind placebo-controlled study, followed by a 6-month open-label transition to alendronate for all patients.
The study's primary endpoint employs the Foundation for the National Institutes of Health Bone Quality Program (FNIH BQP) total hip Bone Mineral Density (BMD) as a surrogate endpoint to evaluate fracture risk.
FDA re-confirmed that with a well-designed BMD study, EB613 approval would not require a fracture study.
The study will also look at secondary endpoints, including changes in the lumbar spine and femoral neck BMD and EB613's effects on biochemical markers of bone formation and resorption.
Related: Entera Bio's Formulated Human Parathyroid Hormone Shows Encouraging BMD Data.
The agency has granted Entera's request for a Type C Meeting based on the revised phase 3 study for the lead clinical asset, EB613, as the first oral anabolic drug to treat postmenopausal women with osteoporosis.
The meeting is expected in H2 2022.
Also, Entera appointed Miranda Toledano as CEO as July 15th, 2022, succeeding Spiros Jamas.
Ms. Toledano has served as Entera's board member since 2018. In May 2022, she also joined as Entera's Chief Business Officer and CFO.
Price Action: ENTX shares are up 12.9% at $1.58 during the premarket session on the last check Monday

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Entera Bio Outlines Pivotal Osteoporosis Trial, Names New CEO