Welcome to our dedicated page for Organovo Holdings news (Ticker: ONVO), a resource for investors and traders seeking the latest updates and insights on Organovo Holdings stock.
Organovo Holdings Inc. (NYSE MKT: ONVO) is a pioneering biotechnology company that designs and creates functional, three-dimensional (3D) human tissues for medical research and therapeutic applications. The company collaborates with pharmaceutical and academic partners to develop human biological disease models in 3D, which can potentially accelerate the drug discovery process, enabling treatments to be developed faster and at lower costs.
Organovo's lead molecule, FXR314, is currently under development for the treatment of inflammatory bowel disease (IBD), including ulcerative colitis (UC). This initiative is based on demonstrated clinical promise in 3D human tissues and robust preclinical data. FXR314 also shows potential applications in metabolic liver diseases and oncology.
The company’s proprietary technology enables the construction of 3D human tissues that mimic critical aspects of native human tissue composition, architecture, function, and disease. These advancements have been prominently featured in numerous scientific publications and media outlets such as The Wall Street Journal, Time Magazine, and The Economist.
Financially, Organovo is gearing up for a public offering expected to close around May 13, 2024, with gross proceeds anticipated to be approximately $5.25 million, excluding potential proceeds from the exercise of common warrants. JonesTrading Institutional Services LLC is acting as the exclusive placement agent for this offering. The company’s financial health and strategic investments position it well for future growth and innovations.
Organovo continues to push the boundaries of medical research and practice, leveraging its groundbreaking technology to improve healthcare outcomes. With ongoing projects and collaborations, the company remains at the forefront of biotechnology, aiming to revolutionize treatments and therapies across various medical fields.
Organovo Holdings (NASDAQ:ONVO) presented Phase 2 clinical trial results for FXR314 at The Liver Meeting. The study involved 214 MASH patients randomized to receive 3mg, 6mg FXR314, or placebo. The drug demonstrated statistically significant liver fat reduction from baseline: 22.8% (3mg) and 17.5% (6mg) versus 6.1% placebo. Notably, >30% MRI-PDFF reduction was achieved in 29.2% (3mg) and 32.2% (6mg) of subjects compared to 9.5% with placebo. FXR314 showed improved safety profile with lower pruritus rates (2.8-4.2%) compared to other FXR agonists, and minimal LDL-C level changes.
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.
FAQ
What is the current stock price of Organovo Holdings (ONVO)?
What is the market cap of Organovo Holdings (ONVO)?
What does Organovo Holdings Inc. specialize in?
What is the significance of FXR314?
Who are Organovo's partners?
How does Organovo's technology benefit drug discovery?
What are the financial highlights of Organovo?
Which diseases is FXR314 targeting?
Where has Organovo's technology been featured?
What are the potential benefits of Organovo's 3D tissues?
What is Organovo's latest financial move?
Who is the placement agent for Organovo's public offering?
