WSW, NY, September 18th, 2026, FinanceWire
Entera Bio Ltd. (NASDAQ: ENTX) has been initiated with coverage by Leerink Partners, which assigned the company an ‘Outperform’ rating and a price target of $9. As of the market close on September 17, 2026, ENTX was trading at $3.03 per share.
Entera is approaching a pivotal stage in the development of what is positioned to become the first oral anabolic tablet for osteoporosis. Its lead program, EB613, is a once-daily oral formulation of PTH(1-34), the same bone-building peptide used in Eli Lilly’s injectable Forteo (NYSE: LLY) but delivered through Entera’s proprietary N-Tab oral peptide platform.
The opportunity exists because osteoporosis has a treatment problem that goes beyond whether effective drugs exist. Anabolic therapies can actively build new bone and are generally reserved for patients at high risk of fracture, yet their use has remained limited in part because the leading treatments require injections. Entera is positioned to potentially remove that barrier by putting an established bone-building peptide into a tablet.
EB613 has already completed a placebo-controlled Phase 2 study in 161 postmenopausal women with osteoporosis or low bone mass. The study met its primary pharmacodynamic endpoint and secondary bone mineral density endpoints, producing statistically significant increases in BMD.
More recently, Entera has cleared several of the hurdles that historically made late-stage osteoporosis drug development unusually difficult.
In June, the FDA provided positive feedback on a streamlined registrational Phase 3 study enrolling approximately 750 postmenopausal women with osteoporosis. The planned study will use change in total hip BMD at 12 months as its primary endpoint, and Entera expects the 12-month data to support an NDA submission for EB613. An open-label extension will follow patients through 24 months to provide additional safety, durability and treatment-sequencing data. The company plans to initiate Phase 3 in late 2026, with topline data anticipated in the second half of 2028.
And unlike many development-stage biotechnology companies approaching a pivotal trial, Entera now appears to have the capital required to run it.
In July, the company completed an oversubscribed $275 million private placement led by existing investor BVF Partners. The financing also brought in a roster of leading institutional healthcare investors including Longitude Capital, Vivo Capital, TCGX, Venrock Healthcare Capital Partners, RA Capital Management, Perceptive Advisors, Driehaus Capital Management, Logos Capital and Catalio Capital Management. Entera said the financing, together with its existing resources, is expected to extend its cash runway into 2030 and fully support the EB613 Phase 3 registrational program through the company’s anticipated NDA submission.
Entera is no longer simply a small biotechnology company attempting to establish whether an oral version of a traditionally injectable peptide can work. The company has generated strong positive data, reached alignment with the FDA on a defined registrational pathway and secured the capital it expects to need to execute that program.
With EB613 approaching Phase 3, a regulatory pathway defined by the FDA and a balance sheet strengthened by one of the largest recent financings in the company’s history, Leerink’s initiation arrives as Entera moves from proving that oral PTH can work toward the considerably larger question of whether it can become a commercial osteoporosis therapy.
Recent News Highlights from Entera (NASDAQ:ENTX):
Entera to Participate in Upcoming Fall Investor Conferences
Entera Announces Second Quarter 2026 Financial Results and Business Updates
Entera Bio to Participate in the Canaccord Genuity 46th Annual Growth Conference
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