CAMBRIDGE, Mass. — Bristol Myers Squibb (NYSE: BMY) announced a definitive agreement to acquire Orbital Therapeutics, a privately held biotechnology company developing RNA-based medicines that reprogram the immune system in vivo. The $1.5 billion all-cash transaction strengthens Bristol Myers Squibb’s industry-leading cell therapy portfolio and introduces an innovative platform for next-generation treatments targeting autoimmune diseases.
The acquisition includes Orbital’s lead preclinical candidate, OTX-201, an investigational in vivo CAR T-cell therapy engineered to reprogram cells within the body. OTX-201 uses an optimized circular RNA encoding a CD19-targeted CAR, delivered through targeted lipid nanoparticles (LNPs), to induce CAR T-cell expression directly in vivo. This approach could significantly reduce treatment complexity and improve accessibility compared to traditional ex vivo CAR T-cell therapies, where cells are extracted, modified, and reinfused.
“In vivo CAR T represents a novel treatment approach that could redefine how we treat autoimmune diseases,” said Robert Plenge, M.D., Ph.D., Executive Vice President and Chief Research Officer at Bristol Myers Squibb. “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.”
In addition to OTX-201, Bristol Myers Squibb will acquire Orbital’s proprietary RNA technology platform, which integrates circular and linear RNA engineering, advanced LNP delivery, and AI-driven design to enable durable, programmable RNA therapies tailored to complex disease biology.
“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, Bristol Myers Squibb. “As a leader in cell therapy, we are uniquely positioned to evaluate multiple 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 of 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, Bristol Myers Squibb will pay $1.5 billion in cash upon closing, subject to customary conditions, including expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Until the transaction closes, both companies will continue to operate independently. The accounting treatment, as a business combination or asset acquisition, will be determined at closing.
