The Bottom Line: Costco (COST) and Hims & Hers (HIMS) are proving that when transformational medicines are coupled with access and convenience, entire drug markets shift. Entera Bio (ENTX), a NASDAQ-traded under-the-radar company, could spark a similar transformation in osteoporosis. Its lead oral candidate, EB613, is designed to be the first bone-building tablet, offering a simple daily treatment for millions who never start injectables. After reporting positive results in their Phase 2 trial, the FDA agreed that bone density gains can serve as the basis for Phase 3, clearing the way for a pivotal trial in 2025. With its N-Tab™ oral peptide platform, an OPKO partnership on oral GLP-1s, and a ~$87M market cap against the backdrop of billion-dollar acquisitions, Entera may be one of biotech’s most overlooked growth stories.

In the world of pharmaceutical investing, spotting the "next big thing" before it reaches blockbuster status can create extraordinary returns. Flashback 2024: few recent examples are as dramatic as the rise of GLP-1 drugs like Wegovy, and newer drugs like Zepbound, which have transformed from diabetes treatments to weight loss sensations that now command a market exceeding $50 billion annually.

Just this week, Costco announced a deal with Novo Nordisk to sell Wegovy and Ozempic to its members at roughly half price, highlighting how demand for easier, more affordable access is reshaping the pharmaceutical market.

A similar opportunity may be emerging in the treatment of osteoporosis, where Entera Bio's (NASDAQ: ENTX) lead candidate EB613 is showing signs of potentially disruptive market potential.

The Parallels Are Striking

Osteoporosis affects approximately 200 million women worldwide, a patient population comparable in scale to the obesity and diabetes markets. Like those conditions, osteoporosis requires chronic therapy and currently relies primarily on injectable treatments for severe cases. In contrast to obesity, however, there has been little innovation in the osteoporosis pipeline, with no new drug approved since 2019 and EB613 seems to stand alone in Phase 3 readiness.

Current anabolic options are injections, daily for teriparatide/abaloparatide and monthly for romosozumab, which many patients are unwilling to take, limiting uptake in eligible patients. Fewer than one in four patients eligible for osteoporosis medication ever receive treatment after a fracture, and roughly 60 percent of diagnosed patients either cannot access or will not start injectables.

The opportunity for EB613 is to open osteoporosis treatment to the millions of patients who remain untreated. As a simple daily tablet treatment, EB613 could be prescribed broadly by primary care physicians, gynecologists, endocrinologists, and rheumatologists, expanding access well beyond the limited pool reached by injectables and potentially making bone-building therapy a realistic option for the mainstream patient population.

Clinical Data Supporting Market Potential

In a 161-patient Phase 2 study, EB613 demonstrated statistically significant improvements in bone modeling markers with a dual mechanism of action and significant increases in bone mineral density (BMD) after just 6 months of treatment. These results were published in the Journal of Bone and Mineral Research in 2024.

BMD is critical because it directly correlates with fracture risk, the key clinical outcome in osteoporosis, which causes devastating morbidity and mortality. Most recently, the FDA agreed that increases in BMD can serve as the basis for approval, a decision that significantly lowers regulatory risk and allows Entera to move into a pivotal Phase 3 trial without waiting years for fracture data. Post-hoc modeling from Phase 2 further suggests EB613’s early trabecular and cortical effects may be in the range reported for injectable anabolics.

The company is now preparing for Phase 3 trials, with a clearly defined regulatory pathway following FDA acceptance of BMD as a registration endpoint.

The Technology Behind the Opportunity

What makes Entera's approach possible is their proprietary N-Tab™ technology, a platform designed to solve the "Achilles' heel" of large, linear peptide delivery by enabling oral administration of peptides that traditionally require injection.

N-Tab™ uses a dual-mechanism approach: synthetic absorption enhancers facilitate systemic bioavailability of peptides, while other platform components prevent enzymatic degradation of the tablet in the digestive tract.

The platform has been validated across multiple peptide targets, with more than 250 subjects dosed in Phase 1 and Phase 2 clinical trials without serious safety concerns.

Market Dynamics Favoring Disruption

Several market factors suggest EB613 could follow a similar trajectory to GLP-1 drugs:

• Massive Untreated Population: Anabolic agents remain underused owing to cost, clinic logistics and monitoring, and the burden of injections. An oral option could change this.
• Expansion of Specialty Drug Distribution: Costco’s recent partnership with Novo Nordisk to make GLP-1 medications available to members illustrates how retail channels are increasingly embracing high-value transformative drugs, where access drives superior health outcomes.
• Insurance Coverage Potential: Fragility fractures impose multi-billion-dollar costs annually (U.S. care costs projected around $25 billion by 2025, Medicare burden estimates near $57 billion), creating strong economic incentives for payers to support effective treatments. Most of these fractures could be prevented with access to more patient-centric oral osteoporosis candidates like EB613.
• Platform Validation: Entera’s technology has demonstrated the ability to deliver therapeutic levels of various peptides orally, reducing technical risk.

Beyond Osteoporosis: A Platform Play

While EB613 represents Entera's most advanced program, the company is simultaneously developing oral GLP-1 and GLP-2 therapies through a partnership with OPKO Health. Their oral oxyntomodulin (OXM) candidate, a dual GLP-1/glucagon agonist for obesity, has shown promising preclinical results, with plasma levels comparable to injectable semaglutide in animal studies.

This dual approach diversifies Entera's potential and provides investors with exposure to both the established GLP-1 market and the emerging opportunity in osteoporosis treatment. Meanwhile, the peptide therapeutics market is projected to more than double from $117B in 2024 to over $260B by 2030, with oral peptides alone expected to approach $20B.

At a market cap of just ~$87M (as of October 8th, 2025 pre market) Entera seems to be deeply under the radar. As with any pharma company at this stage, key risks remain, including replicating bone gains over 24 months, maintaining a clean safety profile, and ensuring adherence to daily dosing. Even so, the combination of early clinical validation, unprecedented regulatory alignment, and a wide-open market opportunity makes this one of the more compelling stories in biopharma right now. For investors looking for the next GLP-1-style growth curve, osteoporosis via Entera may be the place to look.

Recent News Highlights from Entera:

Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress

Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025

Entera Bio Announces Second Quarter 2025 Financial Results and Business Updates

Entera Bio Receives FDA Agreement on BMD as Primary Endpoint for EB613 Registrational, Phase 3 Study in Post-Menopausal Women with Osteoporosis

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