ENTX News & Events

Entera Bio announced the submission to the U.S. Food and Drug Administration of a clinical amendment providing a streamlined Phase 3 protocol, statistical analysis plan, and open-label extension synopsis to the Company's Investigational New Drug (IND) 505(b)(2) submission, to evaluate EB613. Entera anticipates FDA feedback within 60 days. The Company expects to initiate the Phase 3 study in late 2026, with topline results anticipated in the second half of 2028 - approximately one year earlier than previously expected. "This submission marks a pivotal inflection point for Entera and potentially enables us to get EB613 to patients faster," said Miranda Toledano, Chief Executive Officer of Entera. "Our goal with EB613 is to democratize anabolic treatment and enable millions of women and men to protect their bones earlier and potentially deter the catastrophic consequences of fracture. In a silent and asymptomatic disease, access and ease of administration matters."

Entera Bio (ENTX) announced that its Board of Directors has appointed Geno Germano as Chairman of the Board, effective February 4, 2026. Mr. Germano succeeds Gerald Lieberman, who is stepping down as Chairman. Germano is a pharmaceutical and life sciences executive with more than three decades of leadership experience spanning development, commercialization, and global operations. He held senior leadership roles at Pfizer (PFE), including as Group President of Pfizer's Global Innovative Pharmaceutical Business.

OPKO Health (OPK), through its wholly owned subsidiary, OPKO Biologics, and Entera Bio (ENTX), announced the expansion of their 2025 Collaboration and License Agreement to advance the first oral long-acting PTH analog as a once-daily tablet for patients with hypoparathyroidism. The additional program combines OPKO's proprietary long-acting PTH variants with Entera's proprietary N-Tab technology. Following favorable pharmacodynamic and pharmacokinetic data reported in December 2025, the companies have jointly decided to accelerate development and expect to file an IND application with the U.S. Food and Drug Administration in late 2026. Under the expanded collaboration agreement, OPKO and Entera will each hold a 50% pro-rata ownership interest in the LA-PTH hypoparathyroidism program and will each be responsible for 50% of the program's development costs. The companies maintain their previously announced 60%/40% ownership structure and cost-sharing arrangement for the oral OXM program for metabolic and fibrotic disorders.