WSW, NY, October 26th, 2026, FinanceWire
Its $1.275 billion upfront commitment to a Phase 1 program puts the spotlight on oral peptide developers, including Entera as it approaches Phase 3 in osteoporosis.
On October 22, Gilead Sciences (NASDAQ: GILD) agreed to pay $1.275 billion upfront for an oral peptide program from PepStar Therapeutics. Its lead drug, HCXT-2001, is in Phase 1, the earliest stage of human testing. The cash is payable at closing, expected in the fourth quarter.
The program targets inflammatory bowel disease through a ring-shaped peptide that blocks the IL-23 receptor, part of the body’s inflammatory machinery. Gilead is committing more than a billion dollars before the drug has established its safety and efficacy.
Entera Bio (NASDAQ: ENTX) has already generated patient efficacy data for its lead oral peptide, EB613, and is preparing a Phase 3 osteoporosis study. Its entire equity market value was approximately $510 million at the October 23 close. Different diseases and technologies carry different commercial prospects, but the contrast makes the industry’s interest in oral peptides particularly relevant to Entera’s next chapter.
Pharma is pursuing the peptide and the pill
Peptides are chains of amino acids that can act like the body’s own hormones or bind precisely to disease targets. Entera focuses on large, linear peptides (such as PTH and GLP-1-related peptides) whose hydrophilic, or water-loving, nature makes passage through the gut lining particularly challenging. Digestive enzymes can also break them down before they reach the bloodstream. Entera’s proprietary N-Tab platform is designed to protect these complicated peptides during digestion and help them cross that barrier.
That presents a different, potentially more complex delivery challenge than designing a small macrocycle for oral absorption. What distinguishes Entera’s N-Tab platform is its focus on developing tablet treatments based on peptides such as PTH (1-34), GLP-2 and dual GLP-1/glucagon agonists.
The deal activity now extends across both drug discovery and delivery. On September 17, Novo Nordisk (NYSE: NVO) signed an oral macrocycle discovery agreement with Orbis Medicines worth up to $1.4 billion in upfront and potential milestone payments, plus royalties. The partners are pursuing cardiometabolic targets with molecules designed for oral availability. Orbis describes its synthetic macrocycles as chemically closer to small molecules than conventional peptides.
The wider oral-drug push includes different chemistry. In January, Eli Lilly (NYSE: LLY) announced a $1.2 billion agreement to acquire Ventyx Biosciences and its oral small-molecule inflammation pipeline. Gilead’s new program brings that appetite for pills directly into peptide medicine.
For Entera, the opportunity is to apply oral delivery to complex peptide therapies across several diseases, starting with one where effective bone-building medicines already exist and injections remain a barrier to use.
Entera is bringing a proven peptide into a tablet
EB613 is a once-daily oral formulation of PTH(1-34), or teriparatide, the same bone-building peptide used in injectable Forteo. Lilly reported $1.749 billion in worldwide Forteo sales in 2017. Entera’s opportunity is to bring a peptide with blockbuster commercial precedent into a daily pill, potentially opening bone-building treatment to patients reluctant to start injections.
The International Osteoporosis Foundation estimates that osteoporosis affects 200 million women worldwide. Approximately 10 million Americans have the disease, according to the BHOF. Existing oral treatments generally slow bone breakdown; anabolic therapies build bone, but the approved options require injections. That distinction creates an opening for EB613 to expand who receives bone-building treatment and which clinicians prescribe it.
The access barrier is real, and Entera’s once-daily tablet could help unlock a much broader market for bone-building treatment. Injectable anabolics are largely prescribed through endocrinology and rheumatology, while primary care physicians and gynecologists already manage bone health for a much wider population of women. An oral option could make anabolic treatment easier to offer in those practices, without injection training or administration. In a clinician survey published by Entera, respondents estimated that an oral anabolic such as EB613 could reach 38% of their treated patients, compared with a reported 15% share for injectable anabolics today. The potential expansion comes from bringing more prescribers and previously untreated patients into the category.
Entera already has patient data behind that proposition. EB613 completed a six-month, placebo-controlled Phase 2 study involving 161 postmenopausal women with low bone mass or osteoporosis. It met its primary pharmacodynamic (bone-turnover biomarker) endpoint and secondary bone mineral density endpoints. A comparative clinical study presented at ENDO 2026 showed drug exposure and measured biological responses comparable to injectable Forteo, supporting EB613’s advancement into its planned Phase 3 study.
In Entera’s October 13 update, Dr. Felicia Cosman, a Columbia University professor and chair of Entera’s Scientific and Clinical Advisory Board, said, “daily injections remain a barrier for both patients and prescribers.” Entera’s latest design calls for approximately 900 postmenopausal women with osteoporosis in a registrational Phase 3 study, with change in total hip bone mineral density at 12 months as the primary endpoint. A key regulatory milestone arrived in June, when the FDA provided positive feedback on a single Phase 3 trial using 12-month total hip BMD to support a potential NDA. Entera plans a potential New Drug Application (NDA) submission under the 505(b)(2) pathway, including a scientific bridge to Forteo.
The pipeline reaches beyond osteoporosis
The capital to pursue that trial is already in place. Entera completed a $275 million private placement in July led by BVF Partners. The company expects its resources to fund the EB613 Phase 3 registrational program through its anticipated NDA submission and operations into 2030. Together, the recent FDA alignment and financing change the investment case: Entera now has a defined registrational path and the capital to pursue it. The market may still be catching up with that transition, just as major pharma is committing billions to oral drugs and peptide medicines.
Behind EB613 is the EB612 program, a long-acting oral PTH(1-34) replacement candidate for hypoparathyroidism, a condition involving insufficient parathyroid hormone. Entera and OPKO Health (NASDAQ: OPK) each own 50% of that program and share development costs equally. A Phase 1 study is planned for 2027.
EB618 extends the platform into metabolic disease: an oral oxyntomodulin peptide designed to activate both GLP-1 and glucagon receptors. It has produced preclinical data, with clinical development decisions tied to evaluation of OPKO’s injectable program. An oral GLP-2 program for short bowel syndrome adds another potential application.
Gilead’s commitment shows how early major pharma may move when oral peptide biology fits a strategic need. Entera’s next test is approaching: it plans to start EB613’s Phase 3 study in late 2026, with topline results anticipated in the second half of 2028. As the industry spends on the next generation of peptide pills, Entera has a funded route toward a pivotal answer and further candidates following behind.
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