Bristol Myers Squibb to Acquire Orbital Therapeutics for $1.5 Billion to Advance In Vivo CAR-T Therapy OTX-201 and Next-Gen RNA Platform

On October 10, Bristol Myers Squibb (NYSE: BMY, “BMS”) and Orbital Therapeutics (“Orbital”) announced a definitive agreement under which BMS will acquire Orbital, a private biotechnology company pioneering the development of next-generation RNA medicines that reprogram the immune system in vivo, thereby delivering therapies with the precision, control, and flexibility needed to address the underlying biology and unique complexities of each disease.

Dr. Robert Plenge, Executive Vice President and Chief Research Officer at BMS, stated: “In vivo CAR-T therapy represents a wholly new treatment modality that has the potential to redefine the management of autoimmune diseases. This acquisition strengthens our robust cell therapy research platform and provides us with the opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited about the hope this therapy offers to patients with autoimmune diseases who are awaiting better treatment options.”

The acquisition includes Orbital’s leading preclinical RNA immunotherapy candidate, OTX-201, which is currently undergoing studies for an Investigational New Drug (IND) application. OTX-201 comprises an optimized circular RNA encoding a CD19-targeting chimeric antigen receptor (CAR), delivered via targeted lipid nanoparticles (LNPs) for in vivo expression. This in vivo approach leverages the patient’s own body as a manufacturer of CAR-T cells, offering the potential to reduce treatment burden and improve accessibility compared with ex vivo CAR-T cell therapies. Additionally, BMS will acquire Orbital’s proprietary RNA platform, which integrates circular and linear RNA engineering, advanced LNP delivery technologies, and AI-driven design, enabling the customization of durable, programmable RNA therapies tailored to the unique biology of various diseases.

Lynelle B. Hoch, President of BMS Cell Therapy, stated: “With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an excellent opportunity to enhance the efficacy of CAR-T cell therapies and benefit more patients. As a leader in the field of cell therapy, we are uniquely positioned to evaluate various platform approaches for inducing immune reset in autoimmune diseases and to continuously optimize in vivo technologies in clinical development.”

Ron Philip, Chief Executive Officer of Orbital Therapeutics, stated, “This agreement with Bristol Myers Squibb, a globally recognized leader in medicine, marks a transformative moment for Orbital and the advancement of RNA therapeutics. Since its inception, Orbital has made significant progress in developing a differentiated RNA platform aimed at creating a new generation of RNA medicines capable of targeting more tissues, treating more diseases, and benefiting more patients. The encouraging early data from our lead program, OTX-201, highlight the advantages of this approach and the potential of our integrated RNA technology. Together, we are committed to delivering RNA medicines that offer patients simpler, safer, and more accessible treatments than the complex therapies available today.”

Under the terms of the agreement, BMS will pay $1.5 billion in cash to acquire Orbital upon closing of the transaction, subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Until such time, BMS and Orbital will continue to operate as independent companies. Whether the transaction will be accounted for as a business combination or an asset acquisition will be determined at the expected completion of the transaction.