Chronic hepatitis D is better studied than treated. The virus occurs only in people already living with hepatitis B, and it can accelerate progression to cirrhosis, liver failure, and liver cancer. Treatment options remain limited, leaving a meaningful gap between the seriousness of the disease and the therapies available to the people living with it.
That gap is where EIT Pharma is positioning itself: not as a company built around discovering every molecule from scratch, but as one designed to identify promising programs that were left unfinished, secure the rights, and do the clinical, regulatory, and operational work required to move them toward patients. Its lead program, lonafarnib, is an illustration of that strategy.
EIT Pharma bought two programs in 2024 and launched operations early 2025.
Carrying Promising Programs Forward
Lonafarnib was initially developed by Eiger BioPharmaceuticals, which advanced the compound through the pivotal D-LIVR Phase 3 program in chronic hepatitis D before the late-stage asset changed hands. EIT Pharma subsequently secured rights to the program and resumed development.
That sequence is more common in biotechnology than the industry’s discovery-first mythology implies. A drug program may lose momentum for reasons that have little to do with the underlying science: an overextended balance sheet, a shift in corporate priorities, a need to concentrate resources on another therapeutic area, or the difficulty of financing the last stages of development.
For an operator willing to take on complexity, those circumstances can create an opportunity. The opportunity is not merely to acquire a molecule at a discount. It is to recognize when a completed body of clinical work, a defined unmet need, and an executable path forward can together create a credible route to a medicine.
EIT has achieved a meaningful milestone this summer with the filing of its first NDA. The FDA accepted the company’s New Drug Application for lonafarnib in chronic hepatitis D. The compound is an oral farnesyltransferase inhibitor, and in this disease it interferes with the prenylation-dependent assembly that new viral particles require. It already holds Breakthrough Therapy, Fast Track, and Orphan Drug designations. It is not approved for chronic hepatitis D.
The filing of a New Drug Application (NDA) with the U.S. Food and Drug Administration represents a significant and encouraging milestone for any biotechnology company. Although an NDA submission neither assures regulatory approval nor independently confirms a drug’s efficacy or safety profile, it demonstrates the team’s ability to execute a complex clinical, regulatory, manufacturing, and operational process. The Lonafarnib NDA filing is therefore an important step toward potentially bringing the first oral therapy for chronic hepatitis D to patients with this serious disease.
A CEO for the Last Mile
EIT Pharma commenced operations in January 2025 with Leen Kawas as chief executive. Her career is particularly relevant to companies that must do more than generate early scientific enthusiasm. It reflects the later stages of company-building: raising capital, advancing clinical programs, organizing expert teams, building operating infrastructure, and managing the transition from development-stage science toward patient access.
She co-founded Propel Bio Partners with Richard Kayne in 2022 and remains its managing general partner. She sits on the boards of Inherent Biosciences and Persephone Biosciences. Her training is in pharmacology, with a Ph.D. from Washington State University and a pharmacy degree from the University of Jordan. Before Propel, she ran a biopharmaceutical company focused on neurodegenerative diseases, advanced multiple late-stage clinical programs there, and led it through a September 2020 initial public offering that raised more than $400 million. More than a decade of biotechnology leadership sits behind the current role.
Jeffrey Glenn, who co-founded EIT Pharma and holds the Joseph D. Grant Professorship and a professorship of medicine and microbiology and immunology at Stanford University, said the fit between Leen Kawas and the job comes down to operating history. “Her experience building a company from the ground up and carrying it through the full arc of drug development makes her the ideal person to advance EIT Pharma’s mission to deliver life-changing therapies to people impacted by significant unmet medical needs,” he said.
Whether the review ends in approval is not knowable now, and the people closest to it have avoided guessing. A narrower claim already holds. A finished, expensive body of clinical work that had stopped moving got picked up and carried to the point of a regulatory decision by people who knew how that last stretch works.
Leen Kawas has put the stakes in plainer terms. “The people living with chronic hepatitis D have far too few treatment options and no patient should be left behind,” she said when Propel Bio Partners reviewed the company’s progress in August.
The Clinical Need
Chronic hepatitis D is an especially compelling setting for an asset-development strategy because it is both serious and underserved. It affects people who already have hepatitis B and may progress rapidly to severe liver disease.
The D-LIVR study, involving more than 400 participants, is described by EIT as the largest chronic hepatitis D trial conducted to date. It evaluated lonafarnib-based regimens over 48 weeks, including lonafarnib boosted with ritonavir, with and without peginterferon alfa.
The potential importance of an oral component extends beyond pharmacology. In chronic illnesses, how a therapy is administered can shape whether it reaches patients in the first place. Practical treatment options can influence care delivery, long-term adherence, specialist capacity, and access for patients who do not live near major academic liver centers.
None of that resolves the scientific or regulatory questions around any investigational program. It does explain why companies may see strategic value in advancing clinically mature assets in diseases where the treatment shelf is still sparse.
A Repeatable Strategy
EIT’s strategy matters most if it can be repeated. Its pipeline also includes Lambda, an investigational treatment for severe acute viral respiratory infections, suggesting that the company sees lonafarnib not as an isolated transaction but as the first expression of a broader approach.
The premise is simple: identify programs with meaningful evidence and a credible patient need; acquire them when their prior sponsors cannot or will not continue; then apply the capital, execution, and development discipline needed to carry them forward.
For patients living with severe, under-served diseases, that distinction can be consequential. A program that stalls inside one company may still have a path to become a treatment in another. EIT Pharma’s bet is that finishing those programs—carefully, rigorously, and with patient access in view—is not merely an operational exercise. It is a way to create value by delivering therapies to people who have been waiting too long.
