WSW, NY, March 5th, 2026, FinanceWire
As Washington pushes cheaper medicines through TrumpRx, Mark Cuban challenges the pharmaceutical middlemen, and big pharma pours billions into oral peptide technologies, Entera Bio (NASDAQ: ENTX) is pursuing a bold goal: democratizing bone-building therapy for the more than 200 million women living with osteoporosis worldwide.
Entera Bio is moving closer to what could become a major shift in the treatment of osteoporosis: the first oral anabolic therapy designed to rebuild bone. The biotechnology company announced yesterday that it has submitted a streamlined Phase 3 protocol to the U.S. Food and Drug Administration for EB613, its oral PTH(1-34) tablet. The drug aims to deliver the same bone-building hormone used in blockbuster injectable therapies such as Eli Lilly’s Forteo – but in a simple oral pill.
EB613 already demonstrated significant improvements in total hip bone mineral density in its Phase 2 study, supporting the company’s strategy of advancing the therapy toward a registrational program built around this endpoint. If successful, EB613 could fundamentally change how osteoporosis is treated.
Osteoporosis affects an estimated 200 million women worldwide, making it one of the largest chronic disease markets in medicine. Despite the scale of the problem, treatment remains severely underutilized. The most effective therapies today require daily injections, and real-world adherence rates are extremely low. Many patients simply cannot access these expensive drugs. Many patients delay treatment until significant bone loss has already occurred, increasing the risk of fractures that can lead to long-term disability or even death. In the United States alone, osteoporotic fractures already cost the healthcare system more than $57 billion each year, a figure projected to climb sharply as the population ages.
Entera’s approach targets that gap directly. By converting a powerful anabolic hormone therapy into a once-daily oral tablet, the company hopes to make treatment easier, earlier, and more accessible to millions of patients who currently avoid or delay therapy because of injections. As the Company’s CEO, Miranda Toledano noted, with EB613 Entera is looking to “Democratzie access to anabolic therapy” for millions of women and men to protect their bones.
The company’s newly submitted Phase 3 protocol reflects a development path that is dramatically more streamlined than historical osteoporosis programs, which often required several thousand patients and multiple years of follow-up to demonstrate fracture reduction. The planned trial will enroll approximately 750 patients and measure changes in total hip bone mineral density after 12 months of treatment. That timeline is notable.
The program’s design follows a series of regulatory developments over the past year. In July 2025, the FDA aligned with Entera on using total hip bone mineral density as the primary endpoint for the Phase 3 study. Entera was the first company to secure FDA alignment supporting total hip bone mineral density as the primary endpoint for a Phase 3 osteoporosis study – a notable milestone in a therapeutic area that has seen almost no late-stage development activity in the past decade. Later in 2025, the agency formally qualified bone mineral density as a surrogate endpoint for osteoporosis drug development across the category.
Entera also plans to bring its next-generation single-tablet formulation of EB613 directly into the Phase 3 study, meaning the registrational trial will test the version of the drug intended for commercialization. Previously the company hinted at having to conduct additional bridging studies after approval.
The timing of Entera’s progress also aligns with a broader surge of investment in peptide therapeutics across the pharmaceutical industry. Large drugmakers have increasingly moved to replace injectable hormone therapies with oral alternatives, a shift reflected in several high-profile deals over the past year. In December 2025, Pfizer (NYSE: PFE) agreed to pay $150 million upfront – in a deal valued at up to $2 billion – for a Phase 1 oral GLP-1 candidate from YaoPharma. AstraZeneca (NASDAQ: AZN) previously acquired Amolyt Pharma for up to $1.05 billion for a Phase 3 PTH therapy, underscoring the strategic value of endocrine hormone franchises. Johnson & Johnson (NYSE: JNJ) has also pursued Protagonist Therapeutics (NASDAQ: PTGX) in a multibillion-dollar transaction centered on peptide-based therapies. Meanwhile, Entera Bio seems to remain under the radar trading at a market cap hovering around ~$60 million, for now.
The push to make treatments easier to access is also gaining momentum across the healthcare system. Policymakers have increasingly focused on lowering the cost of prescription drugs for chronic conditions, highlighted by initiatives such as the Trump administration’s TrumpRx program, which aims to allow Americans to purchase medicines directly from manufacturers at discounted prices.
At the same time, new distribution models are emerging to challenge traditional pharmaceutical pricing. Mark Cuban’s Cost Plus Drug Company, for example, sells medicines directly to consumers at transparent “cost-plus” pricing designed to eliminate middlemen and reduce costs. Together, these developments reflect a broader shift toward making medicines more accessible. In that context, technologies that simplify treatment itself – such as converting injectable hormone therapies into oral pills – could play an equally important role in expanding access to care. Entera ties directly into this theme, with the stated goal of EB613 being to to Democratize access for anabolic therapy.
Entera expects feedback from the FDA on its Phase 3 protocol within roughly sixty days and anticipates initiating the study in late 2026. If the program proceeds as planned, pivotal results could follow within a year of enrollment.
For a company attempting to bring the first oral anabolic osteoporosis therapy to market, that timeline suggests the next chapter of the story may already be taking shape.
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