Lilly’s $2.4 Billion Orna Deal Signals Push into In Vivo CAR-T Therapies

Eli Lilly and Company announced that it has entered into a definitive agreement to acquire Orna Therapeutics, Inc., a biotechnology company focused on the development of in vivo cell therapies using engineered circular RNA technology. The transaction is intended to expand Lilly’s capabilities in genetic medicines and immunology, particularly in the treatment of autoimmune diseases.

Under the terms of the agreement, Lilly will acquire Orna, with Orna shareholders eligible to receive up to $2.4 billion in cash. This amount includes an upfront payment as well as additional payments contingent upon the achievement of specified clinical development milestones. Lilly will determine the appropriate accounting treatment for the transaction in accordance with Generally Accepted Accounting Principles (GAAP) upon closing, and the transaction will be reflected in Lilly’s financial results and guidance thereafter.

Scientific and Development Rationale

Orna is developing a platform based on fully engineered circular RNA, delivered using proprietary lipid nanoparticle systems. This technology is designed to enable the generation of cell therapies directly within the patient, eliminating the need for ex vivo cell collection and manipulation. Preclinical experiments conducted to date suggest that Orna’s circular RNA platform may provide more durable expression of therapeutic proteins compared with conventional mRNA approaches.

Lilly has identified this platform as a potential solution to limitations associated with current autologous CAR-T therapies, including manufacturing complexity, high cost, and logistical challenges that restrict broad patient access.

 Lead Program Overview

Orna’s lead program, ORN-252, is a clinical trial-ready, CD19-targeting in vivo chimeric antigen receptor T-cell therapy. The program is being developed for the treatment of B cell-driven autoimmune diseases. Early autologous CAR-T studies in autoimmune indications have demonstrated clinical promise; however, widespread adoption has been constrained by the complexity of ex vivo manufacturing processes. Orna’s in vivo approach is intended to address these challenges.

Management Commentary

Francisco Ramírez-Valle, M.D., Ph.D., Senior Vice President and Head of Immunology Research and Early Clinical Development at Lilly, stated that while cell therapies have shown potential benefits for patients with autoimmune diseases, current approaches are difficult to scale. He noted that the acquisition of Orna may enable the development of a new class of genetic medicines and cell therapies for patients with limited or no effective treatment options.

Joe Bolen, Ph.D., Chief Executive Officer of Orna Therapeutics, stated that Orna’s circular RNA technology, combined with its lipid nanoparticle delivery platform, has the potential to support the development of in vivo CAR-T therapies across a broad range of B cell-mediated autoimmune diseases. He indicated that collaboration with Lilly is expected to support further development and potential commercialization of these programs.

Transaction Advisors and Closing

Paul, Weiss, Rifkind, Wharton & Garrison LLP is acting as legal counsel to Lilly. Lazard is serving as financial advisor to Orna Therapeutics, with Goodwin Procter LLP acting as Orna’s legal counsel.

Upon completion of the transaction, Orna’s technology platforms and development programs are expected to be integrated into Lilly’s immunology and genetic medicine research portfolio, subject to applicable regulatory requirements and ongoing clinical development outcomes.

References

Lilly to acquire Orna Therapeutics to advance cell therapies, 09 February 2026, Lilly to acquire Orna Therapeutics to advance cell therapies | Eli Lilly and Company

Lilly to acquire Orna Therapeutics to advance cell therapies, 09 February 2026, https://www.ornatx.com/lilly-to-acquire-orna-therapeutics-to-advance-cell-therapies/