By Natalie Weger

Entera Bio shares climbed after the company said the U.S. Food and Drug Administration agreed with the company's proposal that bone mineral density be the primary endpoint for a phase 3 study in post-menopausal women with osteoporosis.

Shares climbed 22% at $2.27 on Monday, bringing the stock well into positive territory for the year.

The Jerusalem clinical-stage company said the FDA agreed that change in total hip-bone density would be evaluated as the primary endpoint for the study. Incidence of new or worsening vertebral fractures will be evaluated as the key secondary endpoint, Entera said.

This development marks a shift from precedent, as placebo-controlled phase 3 studies of new osteoporosis drugs previously required incidence of fracture as the primary endpoint, Entera said.

Chief Executive Miranda Toledano said Entera's agreement with the FDA allows Enterea to advance its clinical-development program without having to wait for FDA's qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint, which is still expected this year.

Write to Natalie Weger at natalie.weger@wsj.com

(END) Dow Jones Newswires

July 28, 2025 12:36 ET (16:36 GMT)

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