Entera said that the FDA backed its plan for a single large late-stage clinical trial of its experimental once-daily pill, EB613, for postmenopausal women with osteoporosis.
- The main measure of success in the upcoming trial will be how much bone density improves in the hip after one year of treatment.
- Entera expects to begin the trial in late 2026 and report top-line results in the second half of 2028 — about a year earlier than previously planned.
- The company’s earlier mid-stage study of the pill in 161 postmenopausal women met its goals, showing meaningful increases in bone density at the spine and hip.
Shares of Entera Bio Ltd. (ENTX) surged 52% on Monday after the company announced encouraging feedback from the U.S. Food and Drug Administration on its registrational late-stage study design for its most advanced program, EB613.
The stock is on track for its best day since March 2021, if gains hold.
FDA Aligns With Entera
The FDA backed Entera’s plan for a single large late-stage clinical trial of its experimental once-daily pill, EB613, for postmenopausal women with osteoporosis. The study will enroll roughly 750 patients and is designed to support an eventual application for FDA approval.
Osteoporosis is a bone disease that occurs when the body loses too much bone, makes too little bone, or both. As a result, bones become weak, brittle, and highly susceptible to fractures, even from minor falls or bumps.
New Trial Outline
The main measure of success in the upcoming trial will be how much bone density improves in the hip after one year of treatment. The company will also compare its pill to the existing injectable bone-building drug Forteo and include a smaller bone biopsy study in some patients. Patients who finish the main trial will continue in a follow-up study for up to two years to check longer-term safety and benefits.
Entera expects to begin the trial in late 2026 and report top-line results in the second half of 2028 — about a year earlier than previously planned.
Entera Bio is developing EB613 as the first oral version of a bone-building treatment for osteoporosis. All currently approved bone-building drugs must be given by daily injection and are used by only a small portion of patients who could benefit.
The company’s earlier mid-stage study of the pill in 161 postmenopausal women met its goals, showing meaningful increases in bone density at the spine and hip. More recent early testing also showed that a single-tablet version performed similarly to the multi-tablet version used before and to the injectable Forteo.
How Did ENTX Retail Traders React?
On Stocktwits, retail sentiment around ENTX stock jumped from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘normal’ to ‘high’ levels.
A Stocktwits user voiced optimism in the market potential of the drug, thanks to its ease of administration.
The user also applauded the news as massive.
According to data from Koyfin, the analyst covering ENTX rates it a ‘Buy’ with a price target of $9, representing a potential upside of about 643% from the stock’s last close.
ENTX stock has gained about 7% this year.
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