Bristol Myers Squibb and Orbital Therapeutics have announced a definitive agreement under which BMS will acquire Orbital, a privately held biotechnology company pioneering next-generation RNA medicines. Orbital’s platform focuses on reprogramming the immune system in vivo to enable treatments with enhanced precision, control, and flexibility for complex diseases.
“In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases,” said Robert Plenge, MD, PhD, Executive Vice President and Chief Research Officer, BMS. “This acquisition enhances our robust cell therapy research platform and provides an opportunity to advance a potential best-in-class therapy designed to deplete autoreactive B cells and reset the immune system. We are excited by the promise this holds for patients with autoimmune diseases who are waiting for better options.”
The acquisition will include Orbital’s lead RNA immunotherapy candidate, OTX-201, which is currently in IND-enabling studies. OTX-201 is an optimized circular RNA encoding a CD19-targeted CAR for in vivo expression, delivered through targeted lipid nanoparticles (LNPs). This innovative approach, where the patient’s body effectively becomes the manufacturer of CAR T-cells, could significantly reduce treatment complexity and improve accessibility compared to traditional ex vivo CAR T-cell therapies.
BMS will also gain access to Orbital’s proprietary RNA platform, which combines circular and linear RNA engineering, advanced LNP delivery systems, and AI-driven design. This integrated technology enables the creation of durable, programmable RNA therapies tailored to a wide range of diseases.
“With the acquisition of Orbital Therapeutics and its next-generation RNA platform, we have an incredible opportunity to make CAR T-cell therapy more efficient and accessible to more patients,” said Lynelle B. Hoch, President, Cell Therapy Organization, BMS. “As a leader in cell therapy, we are uniquely positioned to evaluate multiple different platform approaches to induce immune reset in autoimmune diseases and continue to optimize in vivo technology in clinical development.”
“This agreement with Bristol Myers Squibb, a recognized leader in global medicine, marks a transformational moment for Orbital and the advancement of RNA medicine,” said Ron Philip, Chief Executive Officer, Orbital Therapeutics. “Since inception, Orbital has made significant strides developing a differentiated RNA platform designed to enable a new generation of RNA medicines that reach more tissues, address more diseases, and benefit more patients. The promising early data from our lead program, OTX-201, underscore the strength of this approach and the potential of our integrated RNA technologies. Together, we aim to deliver RNA medicines that provide patients with treatments that are simpler, safer, and more accessible compared to today’s complex therapies.”
Under the terms of the agreement, BMS will pay $1.5 billion in cash at closing to acquire Orbital. The transaction is subject to customary closing conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Until completion, both companies will continue to operate independently. The accounting treatment—as either a business combination or asset acquisition—will be determined upon the expected close of the deal.
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