WSW, NY, February 9th, 2026, FinanceWire
Entera Bio (NASDAQ: ENTX) just announced that Geno J. Germano, former Group President of Pfizer’s Global Innovative Pharmaceutical Business (NYSE: PFE), has joined the company as Chairman of the Board. The appointment comes as Entera prepares to enter a pivotal phase, with a Phase 3 registrational study for its oral osteoporosis program EB613 planned for 2026 and a second oral PTH program advancing toward the clinic under an expanded partnership with OPKO Health.
A company moving decisively into its execution phase
Entera’s lead asset, EB613, is designed to deliver the same PTH(1-34) hormone used in Eli Lilly’s (NYSE: LLY) Forteo – a drug that reached roughly $1.7 billion in peak annual sales – in a once-daily oral tablet. Forteo’s limitation was never efficacy. It was adherence. Daily injections have historically prevented the majority of eligible osteoporosis patients from ever starting therapy.
In a 161-patient Phase 2 study published in the Journal of Bone and Mineral Research, EB613 demonstrated clinically meaningful improvements in total hip bone mineral density within six months – with results comparable to those historically reported for Forteo.
Just as importantly, Entera achieved an unusually high degree of regulatory alignment that is unprecedented.
In July 2025, the FDA agreed that total hip BMD could serve as the primary endpoint for EB613’s Phase 3 registrational study – a level of clarity that materially reduced regulatory uncertainty for the program. That alignment was further de-risked in December 2025, when the FDA formally qualified total hip BMD as a surrogate endpoint for osteoporosis drug development, an institutional decision that eliminated the need for years-long fracture outcome studies across the category.
With efficacy demonstrated on a regulatorily validated endpoint – and both program-specific and system-wide FDA alignment in place – EB613 has moved decisively beyond scientific proof-of-concept and into a phase where trial execution, regulatory discipline, and strategic positioning matter most.
That is precisely the terrain Geno Germano has spent his career navigating.
Why Germano – and why now
During his tenure at Pfizer, Germano oversaw the company’s global innovative medicines portfolio, leading an approximately $14 billion portfolio spanning marketed products and late-stage development candidates across multiple therapeutic areas. He also co-chaired Pfizer’s Portfolio Strategy and Investment Committee, where decisions were measured not in experiments, but in capital allocation, risk management, and long-term value creation.
Since leaving Pfizer, Germano has served on the boards of several clinical-stage biotechnology companies during periods of late-stage development and strategic transition. Many of those companies – including Sage Therapeutics, Bioverativ, Orbital Therapeutics, and The Medicines Company – were ultimately acquired.
For Entera, the relevance is straightforward. The company is no longer trying to prove that oral peptide delivery works. It is preparing to scale that insight through registrational trials and into the kinds of strategic decisions that define value creation at later stages.
Notably, Germano’s decision to join Entera at this stage likely reflects a belief in the progress already achieved and the opportunity ahead. That conviction is shared at the executive level, where leadership has consistently emphasized long-term alignment with the company’s strategy and trajectory.
A second franchise accelerating in parallel
While EB613 anchors the near-term narrative, Entera’s hypoparathyroidism program has emerged as a second, independently meaningful value driver.
Hypoparathyroidism is a lifelong condition requiring continuous hormone replacement, and the commercial market is now firmly validated. Ascendis Pharma’s (NASDAQ: ASND) injectable PTH therapy, Yorvipath, generated over €100 million in a single quarter and helped propel Ascendis’ market capitalization into the tens of billions. AstraZeneca’s acquisition of Amolyt Pharma for up to $1.05 billion further underscored the strategic value of PTH replacement therapies in the category.
Entera is pursuing a differentiated approach: a long-acting oral PTH tablet. Preclinical data reported in December 2025 showed sustained calcium elevation for more than three days from a single dose, supporting the feasibility of a once-daily oral regimen.
Earlier this month, OPKO Health (NASDAQ: OPK) expanded its partnership with Entera to accelerate the program toward an IND filing targeted for late 2026, with development costs shared equally. The program already holds orphan drug designation in both the U.S. and Europe. Viewed alongside Entera’s balance sheet, the 50/50 cost-sharing structure suggests the company can fund its share of the program through Phase 1.
Leadership aligned with the moment
Germano’s appointment also reinforces continuity at the executive level. Since Miranda Toledano assumed the role of CEO, after serving on Entera’s board since 2018, the company has built a robust pipeline of first-in-class oral peptide programs that did not previously exist, overhauled EB613, achieved unprecedented regulatory alignment, and made significant advances across its pipeline. Prior to Entera, she played a central role at TRIGR Therapeutics, where she helped advance the company’s lead asset through development and strategic partnering before TRIGR was acquired by Compass Therapeutics. That program remains Compass’ lead asset in their pipeline today.
The common thread seems to be a singular strategic vision and disciplined execution – driving EB613 toward Phase 3 while translating Entera’s previously untapped science into a differentiated and increasingly valuable pipeline.
The signal behind the headline
What continues to seem underappreciated is how much of EB613’s risk profile has already been addressed – not at the level of science, but at the level of regulatory execution.
Since late 2022, Entera has worked through a series of complex FDA interactions, but has managed to come out of them significantly derisked. As recently as last month, the company confirmed it is updating its final Phase 3 protocol with the FDA following the qualification of total hip BMD as a surrogate endpoint. The company has stated that this alignment enables a more streamlined Phase 3 program and expects to file the final protocol by the end of the quarter.
That shift matters. Until recently, EB613 remained subject to regulatory processes that could not be accelerated or controlled. Today, that uncertainty has been substantially reduced. Execution is back in the company’s hands.
With regulatory risk largely de-risked and a clear registrational pathway in place, EB613 has reached the stage where strategic options begin to open rather than narrow. In that context, Entera’s recent governance and leadership decisions read less as aspiration and more as alignment with where the program now sits.
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