Entera Bio Announces Upcoming Q1 2026 Corporate Priorities and Pipeline Outlook

Rhea-AI Summary

Entera Bio (NASDAQ: ENTX) outlined Q1 2026 corporate priorities focused on its oral PTH programs. Key near-term milestones: final EB613 Phase 3 protocol submission to FDA planned for Q1 2026 following FDA alignment and a December 19, 2025 qualification of BMD as a regulatory endpoint. A Next‑Gen EB613 Phase 1 bridging study that began in Nov 2025 is progressing with results expected by end of Q1 2026. The company also plans to accelerate EB612, its long‑acting oral PTH candidate for hypoparathyroidism, into clinic in 2026 based on preclinical PK/PD data announced in Dec 2025.

Entera noted prior Phase 2 EB613 results (n=161) met primary PD and secondary BMD endpoints and said it is pursuing strategic partnerships across the pipeline.

Positive

• Planning Phase 3 protocol submission for EB613 in Q1 2026
• Next‑Gen EB613 Phase 1 bridging study started Nov 2025; results expected end Q1 2026
• Phase 2 EB613 (n=161) met primary PD and secondary BMD endpoints
• Plans to advance EB612 into clinic in 2026 based on preclinical PK/PD data

Negative

• EB613 Phase 3 protocol submission is planned but pending FDA review
• Next‑Gen EB613 readout expected by end Q1 2026 is unresolved
• EB612 clinic acceleration is based on preclinical data, not clinical proof

News Market Reaction

+0.64%

3 alerts

+0.64% News Effect

+2.4% Peak Tracked

+$486K Valuation Impact

$76M Market Cap

0.6x Rel. Volume

On the day this news was published, ENTX gained 0.64%, reflecting a mild positive market reaction. Argus tracked a peak move of +2.4% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement added approximately $486K to the company's valuation, bringing the market cap to $76M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Phase 3 timing: Q1 2026 FDA ruling date: December 19, 2025 FDA alignment date: July 29, 2025 +3 more

6 metrics

Phase 3 timing Q1 2026 Planned final EB613 Phase 3 protocol submission to FDA

FDA ruling date December 19, 2025 FDA qualification of BMD as regulatory endpoint for anti-osteoporosis drugs

FDA alignment date July 29, 2025 Regulatory alignment supporting EB613 Phase 3 path

Next-Gen EB613 Phase 1 start November 2025 Initiation of Phase 1 bridging study

Next-Gen EB613 Phase 1 readout End of Q1 2026 Expected results timing for bridging study

EB613 Phase 2 sample size 161 patients Placebo-controlled, dose-ranging study previously completed

Market Reality Check

Price: $1.64 Vol: Volume 133,484 is below 2...

low vol

$1.64 Last Close

Volume Volume 133,484 is below 20-day average of 310,586, suggesting limited pre-news positioning. low

Technical Shares at $1.57 are trading below the $2.06 200-day MA and 51.24% under the 52-week high.

Peers on Argus

Peers show mixed moves (e.g., STRO +5.14%, CRVO -3.32%), while ENTX was down 3.0...

Peers show mixed moves (e.g., STRO +5.14%, CRVO -3.32%), while ENTX was down 3.09%, pointing to stock-specific factors rather than a unified biotech move.

Historical Context

5 past events · Latest: Dec 23 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 23	Regulatory context	Positive	-6.4%	FDA qualification of total hip BMD supporting EB613 Phase 3 pathway.
Dec 22	Preclinical data	Positive	+6.2%	EB612 long-acting PTH preclinical data supporting hypoparathyroidism program.
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 results with going-concern language and funding needs for EB613 Phase 3.
Oct 23	Clinical data	Positive	-7.0%	EB613 Phase 2 post-hoc analysis showing significant BMD gains in women.

Pattern Detected

ENTX has often traded down on otherwise positive osteoporosis and pipeline updates, with only one of the last five news events showing a clearly positive price reaction.

Recent Company History

Over the past six months, Entera Bio has focused on advancing EB613 and its oral PTH platform. Positive Phase 2 EB613 BMD data and July 2025 FDA alignment supported plans for a single registrational Phase 3. Subsequent updates, including FDA qualification of total hip BMD and encouraging EB612 preclinical data, were generally met with mixed to negative price reactions. Going‑concern language in the Nov 14, 2025 10‑Q highlighted funding needs to start Phase 3, framing today’s Q1 2026 milestone roadmap against capital constraints.

Market Pulse Summary

This announcement outlines clear Q1 2026 objectives: submitting the final EB613 Phase 3 protocol, de...

Analysis

This announcement outlines clear Q1 2026 objectives: submitting the final EB613 Phase 3 protocol, delivering Next‑Gen EB613 Phase 1 bridging data, and accelerating EB612 into the clinic. These milestones build on prior FDA alignment and preclinical PTH results, but previous news saw mixed price reactions. Investors may focus on execution of these plans alongside capital needs highlighted in recent 10‑Q filings and subsequent regulatory updates.

Key Terms

phase 3, phase 1, hypoparathyroidism, bmd, +4 more

8 terms

phase 3 medical

"Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026"

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.

phase 1 medical

"Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected"

Phase 1 is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, how the body handles the product, and finding a tolerated dose. Think of it as a short, tightly controlled experiment with a small group to check for dangerous side effects before wider testing; for investors it is an early milestone that reduces some uncertainty but still carries high risk and potential for both big value changes and setbacks.

hypoparathyroidism medical

"Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants"

A disorder in which small glands in the neck fail to make enough of a hormone that keeps blood calcium at the right level, causing low calcium with symptoms such as muscle cramps, tingling or fatigue. For investors, it matters because chronic, hard-to-manage conditions like this create demand for medicines, medical devices and diagnostic tests, shaping clinical trial needs, regulatory review and potential market opportunity much like a persistent mechanical problem creates ongoing demand for repairs.

bmd medical

"qualification of BMD as a regulatory endpoint for anti-osteoporosis drugs"

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.

pk/pd medical

"based on robust preclinical PK/PD data for a proprietary long-acting PTH analog"

PK/PD stands for pharmacokinetics and pharmacodynamics: PK describes how a drug moves through the body — how it is absorbed, distributed, broken down and eliminated — while PD describes the drug’s effects on the body and how those effects change with dose. For investors, strong PK/PD data help predict whether a drug can be dosed safely and effectively, shape clinical trial success, regulatory approval chances and commercial potential, much like knowing both delivery speed and the strength of a message before choosing a shipping method.

glp-1 medical

"targeting PTH(1-34), GLP-1 and GLP-2"

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

glp-2 medical

"first oral GLP-2 peptide as an injection-free alternative"

Glucagon-like peptide-2 (GLP-2) is a naturally occurring gut hormone that helps the intestines grow and absorb nutrients more effectively; drug developers create GLP-2 mimics to strengthen and repair damaged bowel tissue. Investors watch GLP-2 treatments because successful drugs can reduce the need for long-term medical support in patients with severe intestinal disorders, creating a measurable market opportunity and affecting clinical trial, regulatory and reimbursement risk—like backing a tool that helps a leaky pipe work again.

osteoporosis medical

"tablet treatment for post-menopausal women with OsteoporosisBuilding on Entera’s"

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.

AI-generated analysis. Not financial advice.

Final EB613 Phase 3 Protocol Submission to FDA Planned for Q1 2026, Following December 19^th 2025 FDA Ruling

Next-Generation EB613 Phase 1 Bridging Study Progressing with Results Expected During Q1 2026                  

Oral Hypoparathyroidism Tablet Program to Accelerate with Lead Long-Acting PTH Variants

Strategic Partnership Discussions Advancing Across Pipeline

JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptide and protein replacement therapies, today announced its expected corporate milestones for the first quarter of 2026.

“We expect to achieve three important goals during Q1 2026 to drive value for patients with osteoporosis and hypoparathyroidism. We would like to thank the investigators from around the world who participated in our Phase 3 feasibility study, and the patients who are reaching out since our FDA alignment for EB613 in July 2025. We hear  you and remain steadfast in our commitment to advance this important program back into clinic. As a Company, we continue to invest and innovate in therapeutic spaces that have been ignored, require urgent attention and practical treatments and plan to also accelerate our hypoparathyroidism program this year.  This is the second women-centric underserved condition where we believe our oral peptides can make a real difference," said Miranda Toledano, CEO of Entera.

Key Priorities and Expected Milestones for Q1 2026

EB613: First Oral PTH(1-34) Anabolic Tablet Treatment for Post-Menopausal Women with Osteoporosis
Building on Entera’s unprecedented July 29th 2025 alignment with FDA and FDA’s December 19th 2025 broad qualification of BMD as a regulatory endpoint for anti-osteoporosis drugs, Entera is planning to submit its final Phase 3 protocol to FDA in Q1 2026.

Next-Generation EB613
A Phase 1 bridging study of Next-Gen EB613 that initiated in November 2025 is progressing on schedule, with results expected by the end of Q1 2026. The Next-Gen candidate offers significant administration, commercial and strategic advantages.

EB612: Oral Long Acting PTH(1-34) Peptide Tablet for Patients with Hypoparathyroidism
Entera plans to accelerate its hypoparathyroidism program into clinic in 2026 based on robust preclinical PK/PD data for a proprietary long-acting PTH analog announced in late December 2025.

Entera continues to engage in strategic partnership discussions across its pipeline to optimize the development and commercialization pathway for its first-in-class oral peptide programs.

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

FAQ

What is Entera Bio (ENTX) planning for EB613 in Q1 2026?

Entera plans to submit the final EB613 Phase 3 protocol to FDA in Q1 2026.

When will Entera release Next‑Gen EB613 Phase 1 bridging study results for ENTX?

The Next‑Gen EB613 Phase 1 bridging study began in Nov 2025 and results are expected by end of Q1 2026.

What evidence does Entera cite to advance EB612 for hypoparathyroidism (ENTX)?

Entera plans to accelerate EB612 into clinic in 2026 based on robust preclinical PK/PD data announced in Dec 2025.

Did EB613 show efficacy in prior studies for ENTX?

A placebo‑controlled, dose‑ranging Phase 2 EB613 study (n=161) met its primary PD and secondary BMD endpoints.

How does the Dec 19, 2025 FDA action affect Entera's EB613 program (ENTX)?

FDA’s Dec 19, 2025 qualification of BMD as a regulatory endpoint supports Entera’s plan to pursue a Phase 3 pathway for EB613.