Entera Bio Submits Streamlined Phase 3 Plan for EB613

Entera Bio ( (ENTX) ) has shared an update.

Entera Bio announced on March 4, 2026, that it has submitted a streamlined Phase 3 protocol, statistical analysis plan and extension-study synopsis to the U.S. Food and Drug Administration for EB613, its oral teriparatide tablet for postmenopausal women with osteoporosis, under a 505(b)(2) regulatory pathway referencing Forteo. The registrational trial will enroll about 750 patients in a multinational, randomized, double-blind, placebo-controlled study using 12‑month total hip bone mineral density as the primary endpoint, enabling a smaller, faster study and supporting a scientific bridge to Forteo’s long-established efficacy and safety profile.

As part of the redesign, Entera will advance a final single-tablet “Next-Gen EB613” formulation directly into Phase 3, replacing the earlier multi-tablet regimen and potentially simplifying future commercialization and patient adherence. The company expects to initiate the Phase 3 trial in late 2026, target topline data in the second half of 2028—roughly a year earlier than previously planned—and run a 12‑month open-label extension in parallel with a potential regulatory review, a suite of changes that collectively accelerates EB613’s path and could sharpen Entera’s position in the osteoporosis treatment market by offering a non-injectable anabolic option for high-risk patients.

The most recent analyst rating on (ENTX) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Entera Bio stock, see the ENTX Stock Forecast page.

Spark’s Take on ENTX Stock

According to Spark, TipRanks’ AI Analyst, ENTX is a Neutral.

The score is held back primarily by weak financial performance (minimal/declining revenue, persistent losses, and cash burn) and bearish technicals (below major moving averages with negative MACD). Offsetting support comes from low leverage/improved equity and positive corporate developments (expanded OPKO collaboration and FDA Phase 3 agreement), while valuation signals are limited due to negative earnings and no dividend.

To see Spark’s full report on ENTX stock, click here.

More about Entera Bio

Entera Bio Ltd. is a clinical-stage biotechnology company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, where converting injectable biologics into once-daily tablets could transform standards of care. Leveraging its proprietary N-Tab platform, Entera’s lead candidate EB613 is being developed as the first oral, osteoanabolic tablet for osteoporosis, alongside additional oral peptide programs targeting hypoparathyroidism, obesity, metabolic syndromes, and rare malabsorption conditions.

Average Trading Volume: 198,879

Technical Sentiment Signal: Sell

Current Market Cap: $61.45M

For an in-depth examination of ENTX stock, go to TipRanks’ Overview page.