
A privately held US biotechnology company advancing lonafarnib, the only oral candidate in late-stage clinical development for chronic hepatitis D, with an FDA new drug application accepted for review in August 2026. EIT Pharma focuses on serious viral diseases with high unmet medical need, building its pipeline around two antiviral programs acquired through a court-supervised bankruptcy sale. The company describes its approach as an efficient, iterative development process targeting diseases where existing options are limited or absent.
EIT Pharma is headquartered in Kirkland, Washington, at 11335 NE 122nd Way, Suite 105. The company is US-based and privately held, with no public market listing. Its clinical trial footprint reflects the global nature of the D-LIVR program, which enrolled patients across 21 countries.
EIT Pharma was incorporated as Eiger InnoTherapeutics, Inc. and later renamed. The company was formed to acquire specific antiviral assets from Eiger BioPharmaceuticals, which filed for voluntary Chapter 11 protection on 1 April 2024. Through a Section 363 court process, Eiger InnoTherapeutics agreed on 1 August 2024 to purchase the lonafarnib program for $5.2 million and the peginterferon lambda-1a program for $1.0 million. The Bankruptcy Court approved the sale on 20 August 2024 and it closed on 3 September 2024; EIT Pharma is the buyer of those programs, not a corporate successor to Eiger BioPharmaceuticals, which wound down separately.
EIT Pharma's entire clinical focus sits in viral hepatology and antiviral infectious disease. Chronic hepatitis D is its primary target: a life-threatening liver disease caused by hepatitis D virus in people co-infected with hepatitis B, and the most severe form of viral hepatitis due to rapid progression toward liver failure and liver-related death. No oral therapy is currently approved for the disease in the United States, making the clinical case for lonafarnib straightforward even if the absolute response rates from the Phase III trial have drawn scrutiny.
Lonafarnib is a small-molecule farnesyltransferase inhibitor taken orally and stored at room temperature. It targets prenylation of the hepatitis D virus large antigen, a step required for viral assembly and release, thereby disrupting the HDV life cycle directly. In the D-LIVR trial, lonafarnib was pharmacokinetically boosted with ritonavir to increase systemic exposure. The oral route and ambient storage are the attributes that distinguish it most sharply from Gilead's approved injectable competitor Hepcludex.
Lonafarnib is EIT Pharma's lead asset and the subject of an NDA under FDA review following successful completion of the Phase III D-LIVR study. D-LIVR was the largest clinical trial conducted in chronic hepatitis delta, enrolling more than 400 patients across 21 countries in a global, randomized, double-blind, placebo-controlled design over 48 weeks. Both lonafarnib-based arms met the composite primary endpoint, requiring at least a 2-log decline in HDV RNA together with normalization of alanine aminotransferase. The all-oral lonafarnib/ritonavir arm achieved a 10.1% response rate (p=0.0044), while the arm combining lonafarnib/ritonavir with peginterferon alfa achieved 19.2% (p less than 0.0001). Both separated from placebo on virologic and biochemical component endpoints. The absolute response rates are modest by conventional standards, which is the principal clinical debate the FDA review will need to resolve. Lonafarnib holds Breakthrough Therapy, Fast Track, and Orphan Drug designations.
Peginterferon lambda-1a is EIT Pharma's second program, acquired from the same Eiger bankruptcy sale for $1.0 million. It is in Phase II for chronic hepatitis D and for severe acute viral respiratory tract infection. The asset carries a safety footnote: the predecessor LIMT-2 Phase III study in chronic hepatitis delta was stopped by Eiger in September 2023 after a data safety monitoring board flagged hepatobiliary events in four patients. EIT Pharma's plans for its clinical development have not been publicly detailed beyond the Phase II listing.
On 11 August 2026, the FDA accepted for review EIT Pharma's NDA for lonafarnib in chronic hepatitis D; no PDUFA target action date has been published. Twenty days later, on 31 August 2026, the company closed an oversubscribed $35 million Series A financing round to fund the FDA review process and manufacturing and commercial preparations. Those two events together represent the company's transition from clinical-stage acquirer to pre-commercial biotech. The competitive landscape shifted on 22 May 2026, when the FDA granted accelerated approval to Gilead Sciences' injectable Hepcludex (bulevirtide-gmod) as the first approved treatment for chronic hepatitis D in the United States.
Leen Kawas, PhD, serves as chief executive officer. She is a co-founder and managing general partner at Propel Bio Partners, the lead investor in EIT Pharma's Series A, and was previously president and chief executive officer of Athira Pharma until October 2021. Jeffrey Glenn, MD, PhD, is a co-founder of EIT Pharma and the Joseph D. Grant Professor of Medicine and of Microbiology and Immunology at Stanford University.
The $35 million Series A closed on 31 August 2026 was led by Propel Bio Partners, with participation from Good Ventures, Arrowtown, and others. The relationship between Propel Bio Partners and EIT Pharma runs deeper than a typical lead investor: court filings in the Eiger bankruptcy case placed Eiger InnoTherapeutics at the same address as Propel Bio Management LLC, and two of the three founding board members were managing partners at Propel Bio. EIT Pharma remains privately held with no disclosed licensing or co-development partnerships beyond the original bankruptcy asset acquisition.
Hepcludex is injectable, delivered under skin once daily, and its accelerated approval was based on surrogate endpoints with clinical outcomes not yet established. Lonafarnib, if approved, would be the first oral option in the US, which is a meaningful practical difference for a chronic disease requiring long-term adherence. The question the FDA review must answer is whether the D-LIVR response rates, modest at 10.1% and 19.2%, are sufficient to support a standard approval rather than an accelerated one.
Hepatitis D virus depends on prenylation of its large antigen, a lipid modification essential for viral particle assembly and release. Lonafarnib inhibits farnesyltransferase, the enzyme responsible for that modification, blocking a step that is specific to HDV biology. Ritonavir is co-administered as a pharmacokinetic booster, raising lonafarnib plasma levels enough to achieve meaningful antiviral activity at tolerated doses.
Its oral, room-temperature-stable formulation is the clearest differentiator in a field where the only approved agent requires daily injections. It is currently the only oral candidate in late-stage development for chronic hepatitis D and holds Breakthrough Therapy, Fast Track, and Orphan Drug designations from the FDA. The debate around it is not about mechanism but about whether the absolute response rates from D-LIVR are high enough to deliver durable clinical benefit for patients.
D-LIVR enrolled more than 400 patients across 21 countries and tested lonafarnib boosted with ritonavir, with and without peginterferon alfa, over 48 weeks. Both active arms met the composite primary endpoint of at least a 2-log HDV RNA decline plus ALT normalization. The all-oral arm hit a 10.1% response rate and the combination arm 19.2%, both statistically significant versus placebo, though clinicians have raised the modest absolute figures as a point requiring scrutiny.
EIT Pharma holds a second asset, peginterferon lambda-1a, acquired in the same Eiger bankruptcy sale for $1.0 million. Lambda is listed at Phase II in both chronic hepatitis D and severe acute viral respiratory tract infection. The program carries legacy safety questions after the predecessor LIMT-2 Phase III study was halted by Eiger in September 2023 following hepatobiliary events in four patients, and EIT Pharma has not publicly outlined its plans for advancing lambda.
The company is pre-commercial and NDA-stage: the lonafarnib application was accepted by the FDA on 11 August 2026, and no PDUFA date has been published. The $35 million Series A closed 31 August 2026 is explicitly earmarked for supporting that review and for manufacturing and commercial readiness. A regulatory decision, if positive, would make lonafarnib the first oral approved therapy for chronic hepatitis D in the US.
The single most consequential near-term event is the FDA's decision on the lonafarnib NDA.
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