Entera Bio Ltd ENTX shares are trading higher by 47.66% at $6.63 Wednesday after the company announced the topline Phase 2 clinical trial of EB613 met its primary and key secondary endpoints.
Entera Bio says an end-of-Phase 2 meeting with the FDA to review the EB613 development program is anticipated in the coming months. The company plans to conduct a single pivotal one-year Phase 3 study comparing changes in lumbar spine BMD in patients treated with EB613 versus treatment with Forteo, as per a 505(b)(2) pathway.
Entera Bio added that EB613 is positioned to be the first oral bone-building agent for the treatment of osteoporosis.
Entera Bio is a clinical-stage biopharmaceutical company that focuses on the development and commercialization of orally delivered large molecule therapeutics for use in orphan indications and other areas with significant unmet medical need.
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