Eli Lilly has agreed to acquire Orna Therapeutics in a transaction valued at up to $2.4 billion, a move that provides the pharmaceutical company with access to Orna’s in vivo CAR-T technology. Through the deal, Lilly will obtain a pipeline of preclinical programs designed to generate CAR-T cells directly within a patient’s body. The company has indicated that the primary focus of this technology will be B–cell–driven autoimmune diseases rather than oncology indications.
For many years, Lilly remained on the sidelines of the CAR-T field despite acknowledging the promise shown by the modality. Company leadership had previously pointed to challenges related to accessibility, cost, and logistical complexity as key factors limiting broader adoption. In comments made in 2019, Lilly CEO David Ricks summarized the company’s view at the time by saying, “The data is amazing, but practically, it’s not reaching many people.”
According to the announcement, Lilly is now looking to Orna’s technology as a way to address some of those longstanding limitations. The acquisition also makes clear that Lilly’s interest in CAR-T therapies is centered on autoimmune disorders. Other developers in the CAR-T space have similarly begun shifting attention toward non-oncology applications, particularly diseases driven by B cells.
Orna’s development pipeline is still in the preclinical stage. Its lead program, Orna-252, has not yet entered clinical trials but was described by Lilly as “clinical trial-ready.” The candidate is designed to generate CD19-targeting CAR-T cells for the treatment of B–cell–driven autoimmune diseases. Data presented in December 2025 showed that Orna-252 demonstrated the ability to deplete B cells in nonhuman primates.
The technology behind Orna’s programs relies on engineered circular RNA delivered using lipid nanoparticles. This method is intended to prompt cells inside the patient’s body to produce CAR-T cells internally. This contrasts with traditional CAR-T therapies, which require patient cells to be removed, genetically modified outside the body, and then reintroduced. Analysts at William Blair have said that this in vivo approach offers lower manufacturing costs and enables shelf availability.
Lilly Buys Orna to Advance In Vivo CAR-T for Autoimmune Care
Orna Acquisition Strengthens Lilly’s Cell Therapy Strategy
Eli Lilly & Company has announced the acquisition of a clinical-stage biotechnology firm focused on next-generation RNA-based therapies, marking a significant step into in vivo CAR-T treatment development. The deal, valued at up to $2.4 billion including milestone payments, positions the pharmaceutical giant to compete in the rapidly evolving cell therapy landscape.
Unlike conventional CAR-T approaches that require removing immune cells from a patient, engineering them in a laboratory, and reinfusing them, the in vivo method works by delivering genetic instructions directly into the body. This innovation aims to simplify manufacturing, reduce treatment costs, and expand patient access.
Orna Platform Targets Autoimmune Diseases With In Vivo Engineering
The acquired company’s lead program focuses on B-cell-mediated autoimmune diseases, including lupus and other chronic inflammatory disorders. By reprogramming immune cells inside the body, this technology seeks to eliminate harmful B cells responsible for driving disease activity.
The therapy uses circular RNA constructs and lipid nanoparticle delivery systems to instruct immune cells to express specific receptors that target diseased cells. This approach could significantly shorten treatment timelines compared with traditional cell therapies while maintaining strong therapeutic potential.
Autoimmune diseases represent a large and growing global health burden. Many patients do not achieve long-term remission with existing biologics or small-molecule treatments. In vivo CAR-T therapies may offer durable responses by resetting dysfunctional immune systems rather than merely suppressing symptoms.
The acquisition reflects a broader industry movement toward scalable, off-the-shelf cell therapies. Pharmaceutical companies are increasingly investing in technologies that combine genetic medicine, RNA engineering, and immunology to overcome the limitations of traditional biologic drugs.
For Lilly, this transaction enhances its immunology pipeline and complements its expanding portfolio in genetic and metabolic diseases. It also aligns with long-term strategic goals to diversify revenue streams beyond its existing therapeutic areas.
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