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Entera Bio Advances EB613 with FDA Approval

Story Highlights
  • Entera Bio received FDA agreement to use BMD as the primary endpoint for EB613’s phase 3 study.
  • This milestone allows Entera Bio to advance EB613’s development, potentially transforming osteoporosis treatment.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Entera Bio Advances EB613 with FDA Approval

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The latest update is out from Entera Bio ( (ENTX) ).

On July 28, 2025, Entera Bio announced that the FDA has agreed to use Bone Mineral Density (BMD) as the primary endpoint for the phase 3 study of EB613, a treatment for postmenopausal osteoporosis. This decision marks a significant milestone for Entera Bio, allowing them to advance their clinical development without waiting for the FDA’s qualification of the Study to Advance Bone Mineral Density as a Regulatory Endpoint (SABRE). The announcement is expected to impact the company’s operations by accelerating the development of EB613, which aims to be the first oral, once-daily anabolic tablet treatment for osteoporosis, addressing a major unmet medical need in a market that has seen little innovation in recent years.

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.

Entera Bio’s overall stock score reflects a balance between financial challenges and strategic advancements. The company’s financial instability and cash flow issues weigh significantly on the score. However, positive corporate events and strong technical momentum provide some optimism, though valuation remains a concern due to negative earnings.

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

More about Entera Bio

Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs. The company leverages a proprietary technology platform, N-Tab™, and is developing a pipeline of first-in-class oral peptide programs targeting conditions such as osteoporosis, hypoparathyroidism, obesity, and metabolic syndromes.

Average Trading Volume: 39,570

Technical Sentiment Signal: Sell

Current Market Cap: $84.54M

See more data about ENTX stock on TipRanks’ Stock Analysis page.

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