Global pharma powerhouse Eli Lilly is acquiring Orna Therapeutics, a biotech focused on engineering immune cells inside the human body, in a deal that could reshape the future of autoimmune disease treatment.

 

Under the definitive agreement, Lilly will buy Orna outright, with Orna shareholders eligible to receive up to $2.4 billion in cash, including an upfront payment and additional milestone-based payments tied to clinical development progress.

 

The acquisition brings Lilly a novel in vivo cell therapy platform built around engineered circular RNA and proprietary lipid nanoparticles, designed to enable patients’ own bodies to generate therapeutic immune cells. 

 

Orna’s lead program, ORN-252, is a clinical trial–ready, CD19-targeting in vivo CAR-T therapy aimed at treating B cell–driven autoimmune diseases. Early experiments suggest the platform may produce more durable therapeutic protein expression than existing RNA or cell therapy approaches.

 

"Early autologous CAR-T studies have shown the promise of cell therapy for patients with autoimmune diseases, but the complexity, cost, and logistics of ex vivo approaches make it challenging to deliver these breakthroughs to the broader population of patients who need them," said Francisco Ramírez-Valle, Senior Vice President, Head of Immunology Research and Early Clinical Development. 

 

"We look forward to working with Orna colleagues to potentially unlock an entirely new class of genetic medicines and cell therapies for patients who today have limited or no treatment options."

 

Orna’s technology is designed to bypass the manufacturing hurdles of traditional CAR-T therapies, which require cells to be extracted, engineered, and reinfused. By enabling CAR-T generation directly inside the body, the approach could significantly expand access to cell therapies for autoimmune conditions.

 

"At Orna, we believe our circular RNA technology paired with our best-in-class LNP delivery platform have the potential to unlock in vivo CAR-T therapies for patients across a wide range of B cell-driven autoimmune diseases. We are excited to join forces with Lilly, an industry leader in the development of patient-centric therapeutics to realize the full potential of these technologies," said Joe Bolen, Chief Executive Officer of Orna Therapeutics.

 

Lilly said it will determine the accounting treatment of the transaction in accordance with Generally Accepted Accounting Principles upon closing, after which the deal will be reflected in the company’s financial results and guidance.