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Record mula sa primary source

Decision-gradeNaiskedyul ang advisory committee

Entera Bio: sumang-ayon ang FDA sa 12-buwang Phase 3 para sa EB613; topline sa H2 2028

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.

Mahahalagang fact

Na-file
Ago 7, 2026, 08:06 PM
Kaganapan
Naiskedyul ang advisory committee
Direksyon
Positibo
Kumpanya
ENTXEntera Bio
Asset
EB613
Pinagmulan
SEC 8-K
Kumpiyansa
May source
Kalendaryo
Resulta ng trial · Hul 1, 2028
Tagal
12 buwan
N sa Phase 3
750
Pangunahing layunin
porsyentong pagbabago sa kabuuang BMD ng balakang sa Buwan 12

Sipi mula sa source

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

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