WSW, NY, April 24th, 2026, FinanceWire
Osteoporosis is one of the most consequential yet undertreated conditions in modern medicine. Roughly two million osteoporotic fractures occur in the United States every year. Hip fractures alone carry a 21% one-year mortality rate – higher than many cancers – and a quarter of patients who suffer one end up in a nursing home. For context, stage one breast cancer today has a 99% survival rate. Yet in the same country where women diligently schedule annual mammograms, fewer than 30% of eligible osteoporosis patients receive adequate treatment, according to estimates.
Globally, an estimated 200 million women have osteoporosis. The FDA has not approved a new osteoporosis drug since 2019. Anabolic therapies – the most effective class, capable of actually rebuilding bone rather than merely slowing its loss – exist but remain out of reach for the majority of patients who could benefit. Every currently available anabolic requires either daily self-injection or a monthly office visit.
That access gap is precisely what Entera Bio (NASDAQ: ENTX), a clinical-stage biotech developing oral peptide therapies, is attempting to close with its lead candidate EB613.
The Gap Hiding in Plain Sight
In a recent Key Opinion Leader roundtable hosted by the company, two of the most recognized names in bone health and women’s medicine offered a candid look at the treatment gap – and what could close it.
Dr. Steven Goldstein, Professor of Obstetrics and Gynecology at NYU Grossman School of Medicine and former president of both the International Menopause Society and the North American Menopause Society, shared results from a recent survey of practicing gynecologists. The findings are striking. Ninety-two percent of respondents were ordering DEXA scans. Sixty-four percent were actively treating osteoporosis patients. More than 90% were prescribing alendronate. But only 12% prescribed any injectable anabolic agent. When asked whether they would prescribe an anabolic if an oral option were available, 92% said they would.
Gynecologists, Dr. Goldstein noted, function as the primary care physicians for bone health in postmenopausal women in the United States. Yet when patients become severe enough to warrant an anabolic, those gynecologists currently have to refer out — to endocrinologists or rheumatologists — creating a bottleneck where many patients simply never make the appointment, or refuse the injectable once they do. An oral anabolic that the diagnosing physician could prescribe directly, he said, would be “access with a capital A.”
Dr. Felicia Cosman, Professor of Medicine at Columbia University and one of the most published researchers on anabolic osteoporosis therapy, reinforced the clinical logic. The treatment paradigm, she explained, has been shifting over the past two decades toward “anabolic-first” sequencing – using a bone-building drug upfront to rapidly repair the underlying structural defects, then maintaining the gains with an anti-resorptive. The approach is increasingly supported by evidence, but has been difficult to implement at scale because every existing anabolic requires injection.
The Data Behind the Tablet
EB613 is an oral tablet formulation of PTH(1-34) – the same peptide used in Eli Lilly’s injectable Forteo (NYSE: LLY), which peaked at roughly $1.7 billion in annual sales before genericizing. The clinical efficacy of the molecule has been established over more than two decades of use. What Entera has done is solve the delivery problem, through its proprietary N-Tab platform.
In a 161-patient placebo-controlled Phase 2 trial published in the Journal of Bone and Mineral Research, EB613 produced dose-dependent increases in bone mineral density at the lumbar spine, total hip, and femoral neck. A post-hoc 3D-DXA analysis presented at ASBMR 2025 went further, showing significant improvements in both trabecular and cortical bone compartments within just six months of treatment – a profile Dr. Cosman described during the roundtable as comparable to what has been seen historically with injectable PTH at both hip and spine sites. Mechanistically, she emphasized, the data show EB613 stimulating bone formation while simultaneously suppressing bone breakdown – a dual action at the tissue level.
A Regulatory Landscape That Has Moved in Entera’s Favor
The regulatory ground under EB613 has shifted meaningfully in the past nine months. In July 2025, Entera became the first company ever to receive written FDA alignment that a single Phase 3 study using change in total hip BMD as the primary endpoint would support an NDA submission — a significant development given that osteoporosis trials have historically required several thousand patients and fracture-outcome designs spanning five to seven years.
In December 2025, the FDA went further, formally qualifying total hip BMD as a validated surrogate efficacy endpoint for the entire osteoporosis drug development category. The qualification – the product of years of work by the FNIH-ASBMR-SABRE initiative that Entera publicly championed starting in 2022 – removes one of the largest structural barriers to osteoporosis innovation.
Two Developments That Matter Right Now
Against that backdrop, two developments over the past several weeks are worth paying close attention to.
The first is the Phase 3 protocol itself. In March 2026, Entera submitted a streamlined protocol, a statistical analysis plan and an extension study synopsis to the FDA. The registrational plan submitted to FDA is designed to provide 12 month and 24 month monotherapy data for EB613 (via the placebo-controlled 12-month study and the planned 12-month extension study) as well as sequence data of EB613 followed by an anti-resorptive standard of care.
The second is the capital that arrived before that feedback. On April 2, 2026, BVF Partners led a $10 million private placement in Entera, with potential for up to $24.5 million in total proceeds if the attached warrants are exercised. BVF is a specialist biotech investor whose prior positions include ChemoCentryx, Blueprint Medicines, and Protagonist Therapeutics – names that each delivered transformative outcomes for early holders. Proceeds are earmarked specifically for initiation of the EB613 Phase 3.
When two of the field’s most cited experts frame a candidate as the missing piece in a 200-million-patient market, the FDA has cleared both the endpoint and the category-wide surrogate, and a specialist biotech fund with a history of identifying winners takes a direct position while the next regulatory milestone is still pending – the confluence of signals is worth examining. Entera Bio may not stay under the radar for much longer.
To Watch the Full KOL Webinar Replay Click Here
https://www.youtube.com/watch?v=2z6oOgwAWmg
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