Entera Bio CEO Adds to Stake as FDA Qualifies New Osteoporosis Endpoint

Shares of Entera Bio Ltd. (NASDAQ: ENTX) drew investor attention following a new insider purchase disclosed in a regulatory filing.

According to a Form 4 filed with the U.S. Securities and Exchange Commission, Chief Executive Officer Miranda Toledano purchased 11,000 ordinary shares of Entera Bio on December 29, 2025, at a weighted average price of $1.81 per share, representing a total investment of approximately $19,900. The transaction was executed through multiple open-market purchases at prices ranging from $1.75 to $1.82. Following the transaction, the CEO now directly owns 426,575 shares of the company.

Entera Bio is a clinical-stage biopharmaceutical company developing oral formulations of peptide-based drugs, an area traditionally dominated by injectable therapies. The company’s proprietary N-Tab™ oral delivery platform is designed to protect peptides through the gastrointestinal tract and enable systemic absorption, potentially allowing biologic drugs to be administered as tablets rather than injections.

The company’s most advanced program, EB613, is being developed as an oral anabolic treatment for osteoporosis, a disease that affects an estimated 200 million women worldwide and leads to millions of fractures each year. Current anabolic osteoporosis therapies require daily injections, which can limit adoption and long-term adherence.

In a completed Phase 2 clinical study, EB613 demonstrated statistically significant increases in bone mineral density at key skeletal sites, including the spine and hip, along with favorable changes in bone formation biomarkers. Already back in July, The U.S. Food and Drug Administration has agreed that Entera may proceed with a single, placebo-controlled Phase 3 registrational study using bone mineral density as the primary endpoint, an independent regulatory alignment that was a major achievement for the company. But recently, the FDA formally qualified total hip bone mineral density as a validated surrogate regulatory endpoint for novel osteoporosis drugs, a development that further supports EB613’s pathway and could serve as a major confidence booster for those watching.

Beyond osteoporosis, Entera Bio is advancing additional programs built on the same oral delivery technology. These include EB612, an oral peptide replacement therapy candidate for hypoparathyroidism, as well as earlier-stage programs targeting gastrointestinal and metabolic indications.

The company also collaborates with OPKO Health on multiple oral peptide programs, including the development of oral GLP-2 and GLP-1/glucagon dual-agonist tablet candidates, applying the N-Tab platform to peptides that are currently administered by injection.

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