Entera Bio: FDA ने EB613 के लिए 12 महीने के फेज 3 अध्ययन पर सहमति दी; टॉपलाइन 2028 की दूसरी छमाही में

FDA accepted Entera’s single 12-month, placebo-controlled Phase 3 design (n≈750) with total-hip BMD endpoint to support a 505(b)(2) NDA. The company now plans to start the registrational study in late 2026 and expects topline data in the second half of 2028, backed by a $275 million PIPE that funds the program through NDA submission.

मुख्य तथ्य

फाइल किया गया: 7 अग॰ 2026, 08:06 pm
घटना: सलाहकार समिति निर्धारित
दिशा: सकारात्मक
कंपनी: ENTXEntera Bio
संपत्ति: EB613
स्रोत: SEC 8-K
विश्वसनीयता: स्रोत सहित
कैलेंडर: ट्रायल परिणाम · 1 जुल॰ 2028
अवधि: 12 महीने
चरण 3 N: 750
प्राथमिक समापन बिंदु: माह 12 पर कुल कूल्हे BMD में प्रतिशत परिवर्तन

स्रोत का अंश

EX-99.1 2 exhibit_99-1.htm EXHIBIT 99.1 Exhibit 99.1 Entera Announces Second Quarter 2026 Financial Results and Business Updates U.S. Food and Drug Administration (FDA) Alignment on 12-Month Registrational Phase 3 Study to Support NDA for EB613 - the First Oral Anabolic Tablet in Development for Postmenopausal Women with Osteoporosis Oversubscribed $275 Million Private Placement Led by BVF Partners L.P. (“BVF”) with Participation from Leading Institutional Healthcare Investors to Fund EB613 through Anticipated Submission of NDA to the FDA EB613 Phase 3 Study Initiation Planned for Late 2026 with Topline Data Anticipated in the Second Half of 2028 IND Enabling Studies Ongoing for EB612 - the First Oral Peptide Replacement Tablet in Development for Patients with Hypoparathyroidism – In

SEC 8-K