Obeticholic acid

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.