The Business of Biofabrication

Organovo Holdings, Inc. (Nasdaq: ONVO), a clinical-stage biotechnology company pioneering 3D tissue-based drug discovery, announced today the successful completion of the sale of its FXR program—including lead therapeutic candidate FXR314—to Eli Lilly and Company (NYSE: LLY).

The transaction, finalized on March 25, 2025, grants Lilly all commercial and intellectual property rights associated with Organovo’s FXR program. The deal includes an upfront cash payment to Organovo, with additional milestone-based payments tied to FXR314’s progress through key regulatory and commercial stages.

FXR314 has shown promise as a potential treatment for inflammatory bowel disease (IBD), a core focus area for Organovo’s therapeutic pipeline. With Lilly assuming full responsibility for the program’s future development, the pharmaceutical giant is expected to leverage its extensive clinical infrastructure to bring FXR314 through clinical trials and, ultimately, to market.

“This transaction validates our tissue-based drug discovery platform and allows us to focus on advancing other promising assets in our pipeline,” said the company in a press release. “We’re excited to see the FXR program progress under Lilly’s leadership and look forward to its potential impact for patients suffering from IBD.”

About Organovo

Organovo is a biotechnology company at the forefront of 3D bioprinting and tissue engineering for drug development. The company’s proprietary platform builds three-dimensional human tissues that closely replicate the structure and function of native tissues, enabling more accurate disease modeling and drug testing. Organovo’s pipeline is focused on identifying and developing therapies for conditions with high unmet medical need, particularly within gastroenterology.

Original news article.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements regarding the potential of FXR314 to treat inflammatory bowel disease, anticipated milestone payments, future development and commercialization by Eli Lilly, and Organovo’s ongoing strategic focus and pipeline progress. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Factors that could cause such differences include, among others, the success of clinical trials, regulatory approvals, and the ability of either party to meet development goals. Organovo undertakes no obligation to update these statements, except as required by law.