Welcome to our dedicated page for Organovo Holding news (Ticker: ONVO), a resource for investors and traders seeking the latest updates and insights on Organovo Holding stock.
Organovo Holdings, Inc. (Nasdaq: ONVO) generates news as a clinical stage biotechnology company that combines proprietary three-dimensional (3D) human tissue technology with drug development efforts. Company announcements describe a focus on novel treatment approaches in inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, and on drug candidates that are demonstrated to be effective in 3D human tissues.
News related to Organovo often covers updates on its lead clinical stage drug FXR314 and its broader FXR program. Disclosures have included Phase 2 results for FXR314 in patients with Metabolic Dysfunction-Associated Steatohepatitis (MASH), highlighting liver fat reduction, safety, and tolerability, as well as preclinical data in 3D human cellular models of IBD. Additional coverage includes the announcement that Eli Lilly and Company will acquire Organovo’s FXR program, including FXR314, with upfront and potential milestone payments and Lilly assuming responsibility for future clinical development.
Investors and followers of ONVO-related news can also find information on corporate actions and capital markets activity. Recent press releases have discussed a 1-for-12 reverse stock split intended to support compliance with Nasdaq Capital Market listing requirements, issuance of additional shares through warrant exercises and at-the-market stock sales, and updates on preliminary cash balances and net cash utilization. These items provide context on the company’s financial position and listing status.
Another significant theme in Organovo’s news flow is its transition to operate under the name VivoSim Labs, Inc. The company has announced that it will carry forward its 3D bioprinting and legacy technology as VivoSim Labs, Inc., and that its common stock will begin trading under the new ticker symbol VIVS on the Nasdaq Capital Market. Related announcements from VivoSim Labs describe plans to offer liver and intestinal toxicology insights using organoid models from human donor cells and AI-based computational modeling, reflecting how Organovo’s legacy technology is being positioned going forward.
For readers tracking ONVO, this news stream provides historical and transitional context, ranging from clinical data and program transactions to listing-related developments and the evolution of the business identity toward VivoSim Labs, Inc.
Organovo Holdings (Nasdaq: ONVO) announces that its lead clinical stage drug, FXR314, will be featured in an oral presentation at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The presentation, scheduled for November 17, 2024, will be delivered by Dr. Eric Lawitz of the Texas Liver Institute and will discuss findings from the FXR314 Phase 2 MASH study. The presentation will cover pharmacokinetics, safety, and efficacy of this novel non-bile acid FXR agonist in patients with metabolic dysfunction-associated steatohepatitis.
Organovo Holdings (Nasdaq: ONVO) presented its outlook and plans at the Jones Trading Healthcare Conference, focusing on FXR314, its treatment for inflammatory bowel disease (IBD). Executive Chairman Keith Murphy highlighted the strong preclinical and human rationale for FXR314 in Phase 2a ulcerative colitis trials. The company aims to demonstrate FXR314's activity matching results from predictive animal models and 3D human models of ulcerative colitis and Crohn's disease. Murphy emphasized the importance of swift trial completion for investors and patients, noting the strong M&A activity in IBD, referencing Lilly's $3.2B acquisition of Morphic following positive Phase 2a results. The presentation webcast is available for viewing on the Jones Trading website.
Organovo Holdings (Nasdaq: ONVO) presented promising data at Digestive Disease Week (DDW2024) in Washington, D.C., showcasing the potential of FXR314 for treating inflammatory bowel disease (IBD). The study highlights the benefits of combining FXR314, a non-steroidal, non-bile acid FXR agonist, with tofacitinib, a JAK inhibitor. Results showed improvements in intestinal barrier function, inflammation, and fibrosis in 3D and preclinical IBD models. Both compounds, when used at optimal and sub-efficacious concentrations, demonstrated enhanced therapeutic effects. FXR314 alone also showed similar efficacy to approved therapies. These findings support the potential of FXR314 for monotherapy and combination therapy in future clinical studies.
Organovo, a clinical-stage biotechnology company (Nasdaq: ONVO), announces its presentation at Digestive Diseases Week (DDW2024) in Washington, D.C., from May 18-21, 2024. The company will present data on its lead drug, FXR314, a combination therapy with tofacitinib for inflammatory bowel disease (IBD) and ulcerative colitis. The poster titled 'Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory bowel disease' will be showcased on May 18, 2024, at 12:30 EDT. This event is a significant opportunity for Organovo to engage with prescribers and potential partners.
Organovo Holdings, Inc. announced the pricing of a public offering of 6,562,500 shares of common stock and common warrants, expecting gross proceeds of $5.25 million. The offering price per share is $0.80 with common warrants exercisable at the same price. The offering is set to close on May 13, 2024. JonesTrading Institutional Services is the placement agent for the offering.
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