Entera Bio Ltd.(ENTX)Earnings, Financials & Key Ratios

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.

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