Entera Bio

ENTX

Market cap $101M

ENTX stock jumps 35% in a month after the FDA backs a streamlined phase III plan for oral osteoporosis candidate EB613, bringing a key regulatory milestone into focus.

Entera Bio (NASDAQ: ENTX) may have just cleared its biggest regulatory hurdle yet. The FDA has provided positive feedback on the Phase 3 protocol for EB613, the company's oral osteoporosis tablet, creating a clear path toward potential approval and bringing what could become the first oral anabolic osteoporosis treatment one step closer to market.

The planned Phase 3 trial in approximately 750 postmenopausal women with osteoporosis, with a primary endpoint of total hip bone mineral density (BMD) at Month 12, would support Entera's plan to submit a New Drug Application (NDA) for EB613

EB612, a first-in-class long-acting PTH(1-34) oral peptide  for hypoparathyroidism, produced robust bioavailability and sustained increases in calcium across three preclinical models; IND is expected in late 2026

The pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single tablet EB613, multi-tablet EB613 and Forteo® reported for the first time as an oral presentation at ENDO 2026

TEL AVIV, May 28, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that multiple abstracts across its oral peptide pipeline have been accepted for presentation at ENDO 2026, the annual meeting of the Endocrine Society, taking place June 13-16, 2026 in Chicago, Illinois, USA. Notably, new clinical data supporting Entera's single EB613 tablet as the final candidate for its planned Phase 3 study in postmenopausal women with osteoporosis was selected for a Late Breaking Oral Presentation.

EB613, the first oral anabolic (bone building) peptide tablet for postmenopausal women with osteoporosis – Phase 3 protocol submitted with FDA feedback expected imminently; incremental data submitted to ENDO2026 and ASBMR

Entera Bio (ENTX) has been upgraded to a Zacks Rank #2 (Buy), reflecting growing optimism about the company's earnings prospects. This might drive the stock higher in the near term.

Entera Bio Ltd. (ENTX) Discusses Osteoporosis Treatment Landscape and Clinical Potential of EB613 Oral Tablet Transcript

In a virtual Key Opinion Leader (KOL) roundtable hosted today, Entera Bio (Nasdaq: ENTX) convened globally recognized authorities in osteoporosis and women's health to discuss the current osteoporosis treatment landscape and the opportunity for its lead clinical candidate, EB613 - being developed as the first and only oral anabolic (bone-forming) tablet for osteoporosis.