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Entera Bio advances EB613 with FDA alignment and record private placement

Aug 7, 2026, 4:11 PM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Financing significantly reduces near-term dilution risk and extends cash runway to 2030, while FDA alignment and positive Phase 2/Endo signals bolster the odds of a successful NDA for EB613, creating multiple price-positive catalysts within 12–24 months.

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What happened, with direct paths to the underlying reporting

Entera Bio disclosed FDA alignment for a 12-month registrational Phase 3 of EB613, targeting ~750 postmenopausal women and top-line data in 2028. A July 2026 private placement of $275 million funded EB613, EB612, and EB618, extending cash runway to 2030. Positive Endo 2026 data for EB613 and expanded OPKO collaboration enhance near-term and mid-term catalysts.

FDA aligned on EB613 Phase 3 design; enroll ~750 postmenopausal women.
Oversubscribed $275M private placement led by BVF; funds EB613 pipeline.
EB613 Endo 2026 data support single-tablet PK/PD vs Forteo.
EB612 IND planned for H1 2027; OPKO collaboration expanded.
EB618 primate PK/PD data bolster oral GLP-1/glucagon program.

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Entera Bio advances EB613 with FDA alignment and record private placement

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