Entera Bio Congratulates the FNIH-ASBMR-SABRE Team on FDA’s Qualification of Total Hip BMD as Regulatory Endpoint: Huge Win for Osteoporosis Innovation

Rhea-AI Summary

Entera Bio (NASDAQ: ENTX) congratulated the FNIH‑ASBMR‑SABRE team after the FDA on Dec 23, 2025 broadly qualified total hip BMD as a validated surrogate regulatory endpoint for novel osteoporosis drugs in post‑menopausal women at risk of fracture.

Entera highlighted that this qualification reinforces its July 2025 FDA alignment that a single Phase 3 using total hip BMD as the primary endpoint could support an NDA for EB613, and said the move may simplify and accelerate osteoporosis drug development while acknowledging remaining ethical and trial recruitment challenges.

Positive

• FDA qualification of total hip BMD as validated surrogate endpoint (Dec 23, 2025)
• Entera received FDA alignment in July 2025 for single Phase 3 BMD primary endpoint for EB613

Negative

• BMD surrogate threshold effects serve as reference points, not rigid pass/fail criteria
• Ongoing ethical and recruitment challenges remain for osteoporosis trials

News Market Reaction

-6.38% 1.7x vol

5 alerts

-6.38% News Effect

-15.5% Trough in 4 hr 27 min

-$6M Valuation Impact

$86M Market Cap

1.7x Rel. Volume

On the day this news was published, ENTX declined 6.38%, reflecting a notable negative market reaction. Argus tracked a trough of -15.5% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $6M from the company's valuation, bringing the market cap to $86M at that time. Trading volume was above average at 1.7x the daily average, suggesting increased trading activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Women with osteoporosis: Over 200 million Last FDA osteoporosis drug approval: 2019 Phase 3 studies for EB613: Single Phase 3 study

3 metrics

Women with osteoporosis Over 200 million Estimated global prevalence cited in release

Last FDA osteoporosis drug approval 2019 Year of last new osteoporosis drug approval cited

Phase 3 studies for EB613 Single Phase 3 study FDA alignment that one Phase 3 with total hip BMD could support NDA

Market Reality Check

Price: $1.52 Vol: Price up 6.21% with volum...

high vol

$1.52 Last Close

Volume Price up 6.21% with volume 460,178, about 4.4x the 20-day average 104,681 ahead of this news. high

Technical Shares at $1.88 were trading below the 200-day MA of $2.07, despite today’s gain.

Peers on Argus

Among close biotech peers, OVID (+14.74%), STRO (+5.49%) and CRVO (+6.08%) were ...

1 Up

Among close biotech peers, OVID (+14.74%), STRO (+5.49%) and CRVO (+6.08%) were up, while XBIT fell (-3.21%). Momentum scanner only flagged IMUX (+6.07%) and sector-wide direction was unclear, suggesting ENTX’s move was more stock-specific.

Historical Context

5 past events · Latest: Nov 18 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 18	Conference participation	Neutral	-3.0%	Announcement of CEO fireside chat at Evercore ISI healthcare conference.
Nov 14	Earnings and updates	Negative	-1.1%	Q3 2025 results with going concern language and EB613 Phase 3 planning.
Oct 23	Clinical data update	Positive	-7.0%	Positive EB613 Phase 2 BMD gains in early postmenopausal women.
Oct 16	Conference preview	Neutral	+1.3%	Planned presentation of new EB613 Phase 2 data at NAMS meeting.
Sep 15	Clinical PK data	Positive	+1.7%	Positive PK data for first-in-class oral GLP-2 tablet in SBS.

Pattern Detected

Recent news often produced modest, mixed price moves, with most positive updates aligning with small gains and one positive Phase 2 osteoporosis readout coinciding with a notable decline.

Recent Company History

Over the last few months, Entera Bio highlighted progress across EB613 and its oral peptide pipeline. On Sep 15, 2025, it reported positive PK data for an oral GLP‑2 tablet, followed by new EB613 Phase 2 bone density data on Oct 23, 2025. Subsequent NAMS conference participation and Q3 2025 results reinforced FDA concurrence that total hip BMD can support an NDA. Today’s news about FDA qualification of total hip BMD fits this evolving regulatory trajectory for EB613.

Market Pulse Summary

The stock moved -6.4% in the session following this news. A negative reaction despite this regulator...

Analysis

The stock moved -6.4% in the session following this news. A negative reaction despite this regulatory milestone would fit a pattern where prior positive EB613 and GLP‑2 updates sometimes met with only modest or even negative moves. While FDA qualification of total hip BMD supports Entera’s July 2025 alignment around a single Phase 3 for EB613, investors also must weigh the company’s capital needs and going‑concern language from recent filings, which could overshadow incremental regulatory progress.

Key Terms

bone mineral density, bmd, surrogate endpoint, regulatory endpoint, +4 more

8 terms

bone mineral density medical

"broad qualification of total hip bone mineral density (BMD) as a validated"

A measure of how much mineral — mainly calcium — is packed into a given area of bone, usually obtained from a painless scan; higher values generally mean stronger bones and lower fracture risk. Investors care because changes in this measure are often used as proof that drugs, medical devices, or diagnostics work, so it can drive clinical approval, insurance coverage and sales prospects much like a car’s crash-test rating influences buyer confidence and market demand.

bmd medical

"total hip bone mineral density (BMD) as a validated regulatory endpoint"

Bone mineral density (BMD) is a medical measure of how much mineral — mainly calcium — is packed into a specific volume of bone, often reported as a number from a scan. Investors care because changes in BMD are common primary endpoints for drugs and devices treating osteoporosis and bone disorders; stronger effects on BMD can signal higher chances of regulatory approval, broader market use, and bigger revenue potential. Think of it as a method for checking how solid a building’s concrete is.

surrogate endpoint medical

"qualification of Total Hip BMD as a validated surrogate endpoint for novel"

A surrogate endpoint is a measurable substitute used in a clinical trial—like a lab test or imaging result—that stands in for a direct patient benefit, such as longer life or improved daily function. Investors care because regulators may accept these quicker, earlier signals to clear or fast-track a treatment, which can shorten development time, reduce costs and change a drug’s market prospects; think of it as using a thermometer to predict recovery instead of waiting for full healing.

regulatory endpoint regulatory

"total hip bone mineral density (BMD) as a validated regulatory endpoint"

A regulatory endpoint is the specific outcome measure that government regulators use to decide whether a drug, device or medical test meets the standards for approval — essentially the finish line for a clinical study. It matters to investors because hitting or missing that predefined goal drives whether a product can be sold, affects the company’s timelines, risk level and potential revenue; think of it as the scoreboard investors watch to predict success.

phase 3 medical

"a single Phase 3 study with total hip BMD as primary endpoint would support"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

nda regulatory

"single Phase 3 study with total hip BMD as primary endpoint would support an NDA"

An NDA, or nondisclosure agreement, is a legal contract that keeps certain information private between parties. It’s like a promise not to share sensitive details, helping protect business ideas, strategies, or data from being leaked or used without permission. For investors, NDAs help ensure that confidential information remains secure, enabling trust and open communication during business discussions.

osteoporosis medical

"novel drugs in development for post-menopausal women at risk for osteoporotic fracture"

A condition in which bones become thinner and more fragile, making them more likely to break — imagine normal bone turning from solid wood into a brittle sponge. For investors, osteoporosis matters because it creates sustained demand for drugs, diagnostic tests, implants and supportive care, and can influence revenues, regulatory reviews and clinical-trial outcomes in companies involved in bone health and aging-related services.

post-menopausal medical

"novel drugs in development for post-menopausal women at risk"

Post-menopausal describes the stage in a person’s life after they have had their final menstrual period and can no longer become pregnant naturally; it is a long-term biological state marked by lower levels of hormones such as estrogen. Investors care because this status defines who is eligible for certain medical treatments and clinical trials, affects demand for products targeting aging and women’s health, and can change safety and efficacy profiles that influence regulatory approval and market size.

AI-generated analysis. Not financial advice.

FDA qualification of Total Hip BMD as a validated surrogate endpoint for novel osteoporosis drug development further bolsters Entera's July 2025 FDA alignment and regulatory strategy for EB613

Underscores Entera's mission to democratize anabolic treatment for osteoporosis patients and caregivers globally

JERUSALEM, Dec. 23, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, is thrilled to congratulate the FNIH-ASBMR-SABRE¹ team following the Food and Drug Administration (FDA) broad qualification of total hip bone mineral density (BMD) as a validated regulatory endpoint for novel drugs in development for post-menopausal women at risk for osteoporotic fracture.

"Since mid-2022, Entera has been steadfast in our public advocacy and support of the SABRE initiative and the FDA's plan to implement this significant regulatory reform," said Miranda Toledano, Chief Executive Officer of Entera. “Over 200 million women globally are estimated to have osteoporosis and remain vastly undertreated, yet no new drug for osteoporosis has been approved by FDA since 2019. Innovation has stalled largely due to the size, duration, cost and ethical constraints associated with fracture endpoint studies. In the last three years, we have been privileged to forge meaningful ties and build an ecosystem of patients, clinicians, and change agents committed to addressing this significantly underserved area," continued Toledano. "In July 2025, Entera was the first company to receive FDA alignment that a single Phase 3 study with total hip BMD as primary endpoint would support an NDA for EB613. The Agency's position paper and broad qualification may further simplify our path forward."

Key Takeaways from FDA's Review of Full Qualification Package:

• There is need for novel products with enhanced efficacy, tolerability, and ease of use
  
  
• Faster drug development is needed to help alleviate the costs, morbidity, and mortality associated with osteoporosis-related fractures, which are expected to increase substantially as the population ages
  
  
• Given the ethical considerations and recruitment challenges inherent in osteoporosis clinical trials, the development of a validated surrogate endpoint represents a highly valuable regulatory pathway
  
  
• BMD surrogate threshold effects (STEs) may serve as reference points for clinical trial planning rather than rigid pass/fail thresholds, providing sponsors flexibility in regulatory evaluation

About EB613
Substantial evidence supports the efficacy of anabolic treatments over anti-resorptive drugs for lowering fracture risk in osteoporosis patients. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1-34)), is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD.

About Osteoporosis
Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, increased disability, and contribute to premature death. Studies show that up to 20-24% of hip fracture patients die within one year of the fracture. The total medical cost of osteoporotic fractures is projected to increase from $57 billion in 2018 to $95 billion by 2040, largely due to the aging population.  Postmenopausal women are at higher risk of developing osteoporosis-related fractures, particularly in the hip, spine, and wrist. The mechanism for low BMD in postmenopausal women is primary estrogen deficiency, which leads to accelerated bone loss, especially in the first 5-10 years after menopause.

About Entera Bio
Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, "anticipate," "believe," "can," "could," "expect," "estimate," "design," "goal," "intend," "may," "might," "objective," "plan," "predict," "project," "target," "likely," "should," "will," and "would," or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera's forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA's interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera's product candidates; Entera's reliance on third parties to conduct its clinical trials; Entera's ability to establish and maintain development and commercialization collaborations; Entera's operation as a development stage company with limited operating history; Entera's competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera's ability to continue as a going concern absent access to sources of liquidity; Entera's ability to obtain and maintain regulatory approval for any of its product candidates; Entera's ability to comply with Nasdaq's minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera's intellectual property position and its ability to protect its intellectual property; and other factors that are described in the "Cautionary Statement Regarding Forward-Looking Statements," "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Entera's most recent Annual Report on Form 10-K filed with the SEC, as well as Entera's subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Company Contact:
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer, Entera Bio
Email: miranda@enterabio.com

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¹ The Foundation for the National Institutes of Health (FNIH); The American Society for Bone and Mineral Research (ASBMR); The Study to Advance BMD as a Regulatory Endpoint (SABRE)

FAQ

What did the FDA qualify on Dec 23, 2025 regarding osteoporosis endpoints?

The FDA broadly qualified total hip BMD as a validated surrogate regulatory endpoint for post‑menopausal women at fracture risk.

How does the FDA qualification affect Entera Bio (ENTX) and EB613 development?

Entera said the qualification reinforces its July 2025 FDA alignment that a single Phase 3 with total hip BMD could support an NDA for EB613.

Does the FDA qualification guarantee approval of EB613 for ENTX?

No; the qualification provides a regulatory pathway but does not guarantee NDA approval for EB613.

Will total hip BMD remove all clinical trial challenges for osteoporosis drugs?

No; the company noted persistent ethical, size, duration, and recruitment challenges despite the surrogate endpoint.

When did Entera first publicly align with the FDA on using total hip BMD for EB613?

Entera reported it received FDA alignment in July 2025 that a single Phase 3 using total hip BMD could support an NDA.