WSW, NY, February 23rd, 2026, FinanceWire
Entera Bio (NASDAQ: ENTX) is approaching a pivotal stage in the development of its lead osteoporosis candidate, EB613, with final Phase 3 protocol submission expected by the end of Q1 2026 and regulatory alignment now in place around the program’s primary endpoint.
EB613 is an oral peptide of PTH(1-34), developed based on Entera’s proprietary N-Tab platform technology, which enables the development of oral peptides that have historically required injection. PTH(1-34) is the same anabolic hormone used in Eli Lilly’s injectable anabolic, Forteo, which achieved approximately $1.7 billion in peak annual sales. Historically, the limitation of PTH therapy has not been clinical efficacy, but delivery format. Daily injections have constrained real-world adherence, leaving a substantial portion of eligible patients untreated.
Osteoporosis affects an estimated 200 million women worldwide and leads to more hospitalizations than heart attacks, strokes, and breast cancer combined. Hip fractures alone carry roughly a 20% one-year mortality rate. Yet anabolic therapy penetration remains modest, in part due to injection burden. A clinically effective oral option could meaningfully expand treatment uptake.
In a 161-patient Phase 2 study published in the Journal of Bone and Mineral Research, EB613 demonstrated clinically meaningful improvements in bone mineral density (BMD), and follow-up data presented at ASBMR 2025 supported anabolic effects across both trabecular and cortical bone.
Regulatory developments in 2025 further strengthened the program’s positioning. In July, Entera announced FDA alignment supporting total hip BMD as the primary endpoint for its planned Phase 3 registrational study. In December, the FDA formally qualified total hip BMD as a surrogate endpoint for osteoporosis drug development across the category, removing the requirement for lengthy fracture outcome trials.
The company has stated it expects to submit its final Phase 3 protocol by the end of the current quarter, marking a near-term milestone that would further de-risk the start of its much-awaited Phase 3 study. As with all late-stage programs, trial initiation will depend on appropriate capital allocation and strategic planning, but the endpoint framework itself is now clearly defined.
Beyond EB613, Entera is advancing an oral hypoparathyroidism program built on the same N-Tab platform. Hypoparathyroidism is a lifelong endocrine disorder requiring chronic hormone replacement, and the market has already shown it will place enormous value on credible PTH franchises in this category: Ascendis Pharma’s (NASDAQ: ASND) Yorvipath, approved by the FDA in August 2024, drove the company’s market capitalization from roughly $4 billion in 2023 to over $12 billion today – a trajectory built largely on a monopoly position in once-daily injectable PTH replacement for hypoparathyroidism. In parallel, strategic M&A has reinforced the same point, with AstraZeneca acquiring Amolyt Pharma for up to $1.05 billion for a Phase 3 injectable hypoparathyroidism candidate.
Entera is pursuing a differentiated strategy with a long-acting oral PTH tablet. Preclinical data reported in December 2025 demonstrated sustained calcium elevation for more than three days following a single dose, supporting the feasibility of once-daily administration. The program holds orphan drug designation in both the U.S. and Europe.
Earlier this month, OPKO Health expanded its partnership with Entera to accelerate development toward an IND filing targeted for late 2026 with 50/50 economic split. The cost-sharing structure supports the partnership structure while maintaining capital discipline. Entera received $8 million in proceeds from OPKO equity investment in March 2025 which is earmarked for the codevelopments.
The broader peptide therapeutics market is projected to reach approximately $260 billion by 2030, with oral peptide technologies representing a growing segment. Large pharmaceutical companies have increasingly invested in oral peptide programs, reflecting strategic interest in replacing injections with patient-friendly delivery formats in chronic diseases.
At roughly $67 million in market capitalization, Entera trades at a fraction of recent transaction values seen across peptide and endocrine assets. AstraZeneca agreed to acquire Amolyt Pharma for up to $1.05 billion for its Phase 3 injectable PTH program in hypoparathyroidism. In the broader oral space, Pfizer paid $150 million upfront in December 2025 for a Phase 1 oral GLP-1 asset from YaoPharma in a deal valued at up to $2 billion, while Johnson & Johnson’s pursuit of Protagonist Therapeutics to the tune of an estimated $2.6 billion further underscores large pharma’s strategic appetite for peptide platforms. Recent insider purchases and board engagement add another visible layer of alignment as the company advances toward these milestones.
Clinical development carries inherent risks, including funding requirements and trial execution. However, with published Phase 2 data comparative to Forteo, regulatory alignment on endpoints, and oral peptide pipeline diversification, Entera appears positioned at an important juncture. WThe coming quarters are likely to be central in shaping the company’s trajectory.
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