Organovo, Inc.

Organovo\'s stock skyrocketed 244%—welcome news for the company as it faces Nasdaq delisting.\n Eli Lilly has acquired Organovo’s lead asset, a clinical FXR agonist designed to treat inflammatory bowel disease (IBD), in a deal worth up to $50 million in biobucks. Organovo’s stock skyrocketed 244% Tuesday on the news. The deal sees Lilly pay out $9 million upfront plus another $1 million after 15 months to the San Diego biotech, according to Securities and Exchange Commission (SEC) documents filed Feb. 25.Lilly is also offering Organovo the chance to bank potential milestone payments up to $50 million, according to the SEC filing.In exchange, the Big Pharma has acquired all commercial and intellectual property rights to Organovo’s FXR program. This includes lead candidate FXR314, an oral investigational med that the biotech was assessing in a phase 2/3 IBD trial and touted as phase 2-ready in liver fibrosis.The asset also has potential applications in metabolic diseases and oncology, according to the biotech. FXRs, short for farnesoid X receptors, are nuclear receptors mainly expressed in the liver and intestine. FXR agonists are synthetic compounds thought to hold potential across several gastrointestinal (GI) diseases. However, the drug class has faced several setbacks, namely for Intercept Pharmaceuticals. The company was testing its own FXR agonist for metabolic dysfunction-associated steatohepatitis (MASH), a condition characterized by liver inflammation and damage tied to a buildup of fat in the liver.The FDA rejected Intercept’s drug, dubbed Ocaliva or obeticholic acid, for patients with MASH after raising concerns over the drug’s modest efficacy and range of safety problems. That 2023 rejection was the second time the federal agency denied approval for Intercept’s drug in the indication.While Intercept abandoned its MASH plans, the company had secured accelerated approval for Ocaliva in primary biliary cholangitis back in 2016. Last fall, however, the FDA denied Intercept\'s ask for a full nod in the rare liver disease. Earlier, 13 outside experts had voted against the full approval, saying Ocaliva’s clinical benefit wasn’t adequately proven. As for Organovo, FXR314 was developed after being tested in 3D human tissues designed to mimic aspects of human tissue composition, function and disease. “This is a significant milestone for our efforts to advance medicines for IBD using insights from our proprietary 3D human tissue models,” Organovo CEO Keith Murphy said in a press release. “We are excited to deliver FXR314 and our FXR program to Lilly for phase 2 and further development.”The biotech’s stock skyrocketed 244% since the news was announced, although from a low base: rising from just 36 cents at market close on Feb. 24 to $1.27 per share at market close on Feb. 25.This is welcome news, as the biotech had faced the prospect of delisting for the last several months since it was unable to maintain the Nasdaq’s minimum of $1 per share. The company initially had until Jan. 16 to regain compliance but has requested a hearing to delay delisting or suspension.

SAN DIEGO, CA, USA I February 25, 2025 I Organovo Holdings, Inc. (Nasdaq:ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) today announced that Eli Lilly and Company (NYSE:LLY) (“Lilly”) will acquire Organovo’s FXR program, including its lead asset, FXR314. “This is a significant milestone for our efforts to advance medicines for IBD using insights from our proprietary 3D human tissue models,” said Keith Murphy, Executive Chairman. “We are excited to deliver FXR314 and our FXR program to Lilly for Phase 2 and further development. Their world-class development excellence and dedication to delivering for patients will provide an excellent pathway for FXR314 success, and we are pleased to have this opportunity to deliver for patients.” Under this transaction, Organovo will receive an upfront payment as well as milestones to be paid as FXR314 achieves key regulatory and commercial milestones. Lilly is acquiring all commercial and intellectual property rights to Organovo’s FXR program for worldwide development. About Organovo Organovo is a clinical stage biotechnology company that is developing drugs that are demonstrated to be effective in three-dimensional (3D) human tissues as candidates for drug development. The company has proprietary technology used to build 3D human tissues that mimic key aspects of native human tissue composition, architecture, function, and disease. For more information visit Organovo’s website at www.organovo.com . SOURCE: Organovo

Organovo Holdings宣布，礼来（Eli Lilly and Company）将收购该公司旗下的FXR项目及主打疗法FXR314。 Organovo是一家处于临床阶段的生物技术公司，专注于开发在其专有三维（3D）人体组织模型平台中已验证疗效的潜在疗法。该平台能够构建出在组成、结构、功能以及病理特征上高度模拟天然人体组织的3D模型，为药物开发提供了独特而先进的实验工具。 FXR314是一款潜在“best-in-class”的口服FXR小分子激动剂。目前，Organovo已获得美国FDA的临床试验许可，正在进行其主打疗法FXR314用于治疗溃疡性结肠炎（UC）的2期试验。公司通过其专有的3D人体组织模型，制定了针对FXR314的高效临床开发策略，该策略不仅适用于溃疡性结肠炎，也可用于治疗包括克罗恩病在内的其他炎症性肠病。Organovo同时推动FXR314在治疗肝脏疾病方面的应用，包括代谢相关性脂肪性肝炎（MASH）和原发性胆汁性胆管炎。初步临床试验结果表明，FXR314具备高效力、安全性和良好耐受性，并有望规避其他FXR靶向药物常见的剂量限制性毒性问题。 根据协议，Organovo将获得一笔预付款，并在FXR314达成关键监管和商业里程碑时获得相应款项。礼来则将获得Organovo的FXR项目在全球范围内的全部商业开发权利。 参考资料： [1] Organovo’s FXR Program, including FXR314, to Be Acquired by Eli Lilly and Company. Retrieved February 25, 2025 from https://www.globenewswire.com/news-release/2025/02/25/3032003/0/en/Organovo-s-FXR-Program-including-FXR314-to-Be-Acquired-by-Eli-Lilly-and-Company.html [2] Pipeline. Retrieved February 25, 2025 from https://organovo.com/pipeline/ 内容来源于网络，如有侵权，请联系删除。