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EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – FDA Type A ...

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The submission also includes a protocol synopsis for a 12-month open-label extension study where participants would be randomized to EB613 through 12 or 24 months of treatment or transition to a ...

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Phase 3 study designed with total hip BMD primary endpoint assessed at 12 months, rather than at 24 months EB613 single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet EB613 ...

EB613 single tablet final commercial formulation (Next-Gen EB613) replaces multi-tablet EB613 as Phase 3 candidate, following successful bridging study Topline data anticipated in the second half of ...

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