Entera Bio ENTX shares have rallied about 34.5% over the past month, driven by investor optimism after the company received positive FDA feedback on the phase III registrational study design for EB613, its lead candidate for postmenopausal osteoporosis. The FDA supported Entera's proposal to conduct a single phase III study evaluating the oral therapy over 12 months, clearing a key regulatory hurdle for what could become the first oral anabolic treatment for the disease. ENTX expects to begin the pivotal study in late 2026, with top-line results anticipated in the second half of 2028.
EB613 is an oral formulation of parathyroid hormone (PTH) designed to stimulate new bone formation. Unlike currently marketed anabolic osteoporosis therapies that require subcutaneous injections, EB613 is being developed as a once-daily oral tablet, potentially improving convenience and treatment access. The program is being pursued through the FDA's 505(b)(2) pathway by leveraging clinical experience with Eli Lilly's LLY injectable Forteo(teriparatide), while utilizing Entera's proprietary N-Tab oral peptide delivery platform. The company is also advancing a final single-tablet commercial formulation intended to replace the earlier multi-tablet version.
LLY’s Forteo was first approved by the FDA in 2002 for the treatment of postmenopausal women with osteoporosis and subsequently for treatment of men with primary or hypogonadal osteoporosis at high risk of fracture, and for osteoporosis associated with sustained systemic glucocorticoid therapy.
Details of ENTX's Planned Phase III Osteoporosis Program
The FDA endorsed Entera's plan to conduct a pivotal phase III study of EB613, enrolling approximately 750 postmenopausal women with osteoporosis. The primary endpoint will measure the percentage change from baseline in total hip bone mineral density (BMD) at 12 months, a design intended to support a potential New Drug Application (NDA) for the candidate in the above indication. The submission package is also expected to include a scientific bridge to Lilly's Forteo under the 505(b)(2) pathway, along with findings from a transiliac crest bone biopsy sub-study in a subset of patients.
Year to date, ENTX shares have gained 2.5% compared with the industry’s 2.4% growth.
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In addition, regulators agreed with Entera's proposal to continue monitoring patients for up to 24 months through a separate open-label extension study. ENTX plans to submit safety data covering up to 18 months during the NDA review process, while complete two-year data will later be used to further characterize the therapy's long-term safety, durability of response and treatment sequencing with standard anti-resorptive therapies.
The pivotal study is designed to demonstrate EB613’s clinical efficacy by achieving total hip BMD improvements comparable to those reported with Lilly'sForteo at 12 months, changes that have been linked to a 60% to 80% relative reduction in vertebral fracture risk.
Previously, Entera completed a six-month, phase II study evaluating EB613 in 161 postmenopausal women. The study met both its primary biomarker endpoint and secondary BMD endpoint, demonstrating statistically significant BMD gains at the lumbar spine, total hip and femoral neck. Notably, total hip BMD improvements were comparable to those reported with Lilly’s Forteo at the six-month mark. More recently, early-stage data presented at ENDO 2026 showed that the next-generation single-tablet formulation of EB613 achieved pharmacokinetic and pharmacodynamic profiles comparable to both the earlier multi-tablet EB613 formulation evaluated in the phase II study and Forteo.
ENTX’s Earlier Regulatory Filing Streamlines Phase III Plan
The June FDA update followed an important regulatory filing made in March 2026, when Entera submitted a streamlined phase III protocol seeking to shorten the registrational program. Under the revised design, the primary endpoint was shifted to 12 months from the previously planned 24 months, reducing both study duration and execution complexity. The protocol also lowered the expected study population size to about 750 patients, while advancing the final single-tablet formulation directly into phase III after successful bridging studies.
The March submission also projected top-line phase III data in the second half of 2028, roughly one year earlier than previously expected. Entera noted that the streamlined strategy relied on prior FDA alignment, extensive clinical experience with Eli Lilly's Forteo and growing regulatory acceptance of total hip BMD as a surrogate endpoint for fracture risk reduction.
Beyond EB613, Entera is advancing EB612, an oral PTH therapy for hypoparathyroidism, including a proprietary long-acting PTH program being co-developed with OPKO Biologics under a 50-50 collaboration. The partners expect to submit an investigational new drug application (IND) to the FDA in late 2026. ENTX is also developing EB618, an oral dual GLP-1/glucagon (oxyntomodulin) agonist for obesity and metabolic disorders using its N-Tab platform. Following encouraging early pharmacokinetic and pharmacodynamic data, OPKO plans to initiate a phase I study of the injectable formulation of EB618 in 2027, after which Entera intends to file an IND for the oral tablet version.
Entera Bio Ltd. Price and Consensus
Entera Bio Ltd. price-consensus-chart | Entera Bio Ltd. Quote
ENTX's Zacks Rank & Stocks to Consider
Entera currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Neurocrine Biosciences NBIX and Liquidia Corporation LQDA, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Neurocrine Biosciences’ 2026 earnings per share have risen from $9.15 to $9.44. Over the same period, EPS estimates for 2027 have increased from $10.23 to $10.79. NBIX shares have gained 22% year to date.
Neurocrine Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 9.08%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have increased to $3.02 from $2.97. Over the same period, EPS estimates for 2027 have risen to $4.92 from $4.81. LQDA shares have soared 123.5% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, the average surprise being 54.40%.
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