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  Title	Entera Takes Final Step Towards Phase 3, Accelerating Timeline for First Oral Anabolic Osteoporosis Therapy
  ID	30811645
  External ID	entera-takes-final-step-towards-phase-3-accelerating-timeline-for-first-oral-anabolic-osteoporosis-therapy
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  Published Date	March 12, 2026, 8 a.m.
  Summary	Advertisement Entera Takes Final Step Towards Phase 3, Accelerating Timeline for First Oral Anabolic Osteoporosis Therapy Newswire TipRanks A+ A- WSW, NY, March 12th, 2026, FinanceWire Last week Enter
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  URL	https://www.tipranks.com/news/newswire/entera-takes-final-step-towards-phase-3-accelerating-timeline-for-first-oral-anabolic-osteoporosis-therapy
  Sentiment	Negative: 0.01519    Neutral: 0.59077    Positive: 0.39404
  Relevance	0.02299

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  Content ID	37935655
  Key	82176948-c4ca-4a2a-b0c0-acff7ac9fd54
  Content	Advertisement Entera Takes Final Step Towards Phase 3, Accelerating Timeline for First Oral Anabolic Osteoporosis Therapy Newswire TipRanks A+ A- WSW, NY, March 12th, 2026, FinanceWire Last week Entera Bio ( NASDAQ:ENTX ) announced that it had taken what appears to be the final step before launching its Phase 3 registrational program for EB613, the first oral bone building tablet for osteoporosis. The company recently announced that it submitted a streamlined Phase 3 protocol to the FDA – a milestone that reflects the culmination of a regulatory strategy Entera has been executing since 2022. Notably, the development also comes amid a series of recent insider purchases, with new Form 4 filings this week showing director Sean Ellis and chairman Geno Germano buying shares on the open market – a pattern the market often interprets as a signal of internal conviction. For those who have followed the company closely, the significance lies not just in the protocol submission itself, but in the sequence of developments that made this design possible. Entera has proactively advocated for the use of total hip bone mineral density (BMD) as the primary endpoint for its registrational study and frankly, to spur innovation for osteoporosis drug development in general – citing the statistical work carried out by the SABRE group and consistently highlighting the enormous size and ethically prohibitive issues involved with fracture-outcome trials that have historically defined osteoporosis drug development. That strategy began to pay off in July 2025, when the FDA aligned with Entera that total hip BMD could be used as primary endpoint for EB613’s planned Phase 3 study. This was a first and Entera had in essence paved the way for innovation to open for osteoporosis drug development. In December, the regulatory landscape shifted further when the FDA formally qualified total hip BMD as a surrogate efficacy endpoint to fracture. The importance of that shift is significant. Historically, registrational osteoporosis trials required between roughly 2,500 and 14,000 patients and often stretched across five to seven years to capture fracture outcomes over 18 to 36 months. Entera’s proposed Phase 3 program looks very different. According to the protocol submitted to the FDA, the study is designed to enroll approximately 750 postmenopausal women with osteoporosis and evaluate percent change in total hip BMD as the primary endpoint after twelve months of treatment. In practical terms, the company aims to generate pivotal data in roughly half the time investors might traditionally expect for a phase 3 osteoporosis study while dramatically reducing the scale of the trial itself. The Company has also committed to an extension study after the 12 month registrational study which will provide sequence and 24 month data for EB613. Just as important as the trial design is the formulation Entera plans to take into Phase 3 – the next-generation single-tablet version of EB613. Earlier clinical studies used a multi-tablet regimen, but the company has since developed a simplified once-daily tablet intended to serve as the commercial formulation. Osteoporosis is a chronic disease in which treatment adherence has long been a challenge. The most effective anabolic therapies currently available require daily or two monthly injections, a factor that has historically limited adoption even among patients who would clearly benefit from treatment. A simple oral tablet could remove a meaningful barrier to real-world use. By bringing the single-tablet formulation directly into Phase 3, Entera is effectively testing the version of the therapy intended for commercialization. For pharmaceutical companies evaluating late-stage assets, that alignment matters. Programs that still require formulation changes after pivotal trials often introduce additional complexity, whereas Entera’s registrational study is designed around the commercial candidate itself. The submission also clarifies the program’s development timeline. Entera expects feedback on its protocol from the FDA within roughly sixty days and could still initiate the Phase 3 study in late 2026. With a twelve-month primary endpoint, topline results are projected for the second half of 2028 – considerably sooner than would have been possible under traditional osteoporosis development frameworks. For a company currently operating at a microcap valuation, that acceleration is meaningful. The timeline to pivotal data often determines when strategic interest begins to build, as larger pharmaceutical companies tend to focus more closely on programs once a clear registrational pathway and timeline are established. Entera’s Phase 3 submission arrives at a moment when several other developments have begun reinforcing the company’s broader trajectory. Earlier this year, Entera expanded its partnership with OPKO Health to advance a long-acting oral PTH program for hypoparathyroidism, with both companies sharing development costs equally as the program moves toward an IND filing targeted for late 2026. The arrangement allows the program to progress while preserving capital and further demonstrates the potential of Entera’s N-Tab technology platform, which is designed to enable the oral delivery of peptide hormones that historically required injection. At the same time, the company has seen visible alignment from its leadership and board. CEO Miranda Toledano disclosed an open-market share purchase in late 2025, and multiple board members followed with additional purchases earlier this year and this week as well, as the stock retraced from levels above $3. Insider buying does not guarantee success, but it often reflects how leadership views the gap between valuation and progress. Another notable development was the appointment of Geno Germano as Chairman of the Board. Germano previously served as Group President of Pfizer’s Global Innovative Pharmaceutical Business, overseeing a portfolio generating roughly $14 billion in annual revenue. Viewed in that broader context, the Phase 3 protocol submission looks less like a routine regulatory step and more like the final piece of a development framework the company has been building for several years. While drug development always carries uncertainty, EB613’s phase 3 now appears positioned around a regulatorily validated endpoint, a manageable trial size, a commercially relevant formulation, and a development timeline that brings pivotal data meaningfully closer. Read this Next >> Codexis Reports Fourth Quarter and Fiscal Year 2025 Financial Results ( NASDAQ:CDXS ) Recent News Highlights from Entera Bio (NASDAQ:ENTX) Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis Entera Bio Announces Open Market Purchases of Company Stock by Board Members Entera Bio Appoints Former Pfizer Executive Geno J. Germano as Chairman of the Board Ahead of Key Milestones OPKO Health and Entera Bio Expand Partnership to Advance First-in-Class Oral Long Acting PTH Tablet for Patients with Hypoparathyroidism Important Disclaimers and Disclosures: The author, Wall Street Wire, is a content and media technology platform that connects the market with under-the-radar companies. The platform operates a network of industry-focused media channels spanning finance, biopharma, cyber, AI, and additional sectors, delivering insights on both broader market developments and emerging or overlooked companies. Wall Street Wire is not a broker-dealer or investment adviser. References to market size estimates, valuations, price targets, or other third-party data are provided strictly for informational purposes. Wall Street Wire receives cash compensation from Entera Bio Ltd for coverage and awareness services, which are provided on an ongoing subscription basis. The content above is a form of paid advertising and promotion and is for informational purposes only and does not constitute financial or investment advice. Full compensation details, information about the operator of Wall Street Wire, and the complete set of disclaimers and disclosures applicable to this content are available at: wallstwire.ai/disclosures. This article should not be considered an official communication of the issuer. Contact Wall Street Wire [email protected] If you want to submit your press release through TipRanks NewsWire, please go to the following link . 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  Trust Flow Score	23
  Citation Flow Score	57

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  Data Source Name	TipRanks (#305)
  Data Source Type	news
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