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. (ONVO) is a leader in 3D bioprinting technology focused on creating functional human tissues for medical research and therapeutic development. This page serves as the definitive source for verified news and official announcements related to the company’s scientific advancements and business operations.
Investors and researchers will find timely updates on clinical research programs, strategic partnerships with pharmaceutical companies, and developments in Organovo’s proprietary 3D tissue platforms. The curated collection includes press releases about preclinical studies, technology licensing agreements, and financial performance updates.
All content is rigorously verified to ensure accuracy, with direct links to primary sources such as SEC filings and peer-reviewed publications. Regular updates provide insights into Organovo’s work in areas like inflammatory bowel disease research and tissue model validation.
Bookmark this page to stay informed about ONVO’s progress in bridging the gap between laboratory discoveries and real-world therapeutic applications through innovative 3D bioprinting solutions.
VivoSim Labs (Nasdaq: VIVS) has emerged from stealth mode to revolutionize drug development with its NAMkind™ services suite, following FDA's announcement to phase out animal testing requirements. The company's technology focuses on liver and intestinal toxicology using human organ model-based lab testing and AI-powered computational modeling.
The company aims to disrupt the $10B+ animal testing market with more predictive and ethically sound methods. VivoSim's liver model has demonstrated industry-best correlation rates with known clinical failures, and the company projects it can reduce clinical trial failures due to liver toxicity by 50% or more.
The technology utilizes physical organoid wet lab models created from human donor cells, combined with AI-driven predictions for liver toxicity, intestinal toxicity, and permeability. VivoSim believes its approach could reduce drug development costs per approved drug by 50% across the industry.
Organovo Holdings (Nasdaq: ONVO) has announced its transformation into VivoSim Labs, Inc., marking a strategic evolution of its 3D bioprinting and legacy technology operations. The company's name change will take effect on April 24, 2025, accompanied by a new ticker symbol 'VIVS' on the Nasdaq Capital Market.
The transition requires no action from existing stockholders, and the company will maintain its current CUSIP number (68620A302) and Nasdaq Capital Market listing. This corporate rebranding represents a continuation of Organovo's established bioprinting technology under the new VivoSim identity.
Organovo Holdings (NASDAQ: ONVO), a clinical stage biotechnology company focused on IBD treatments, has provided a financial and listing status update. The company reported preliminary unaudited cash and cash equivalents of approximately $11.3 million as of March 31, 2025, with net cash utilization of $2.0-$2.2 million in Q4 FY2025.
The company expects to maintain its Nasdaq Capital Market listing as its stock has traded above the required $1.00 minimum bid price since March 21, 2025. Full fiscal Q2 results are expected between June 9-13, 2025.
Additionally, Organovo anticipates receiving a $5 million milestone payment within the next 12 months upon the start of a Phase 2 clinical trial for its recently sold FXR agonist. The company could receive up to $50 million in total future milestone payments related to this asset.
Organovo Holdings (NASDAQ:ONVO), a clinical stage biotechnology company focused on inflammatory bowel disease (IBD), provided a business update following the sale of its FXR Program to Lilly (NYSE:LLY). The company has received upfront payments and expects future milestone payments from this deal.
The company anticipates reduced expenditures in the coming year due to the elimination of FXR314-related costs. With current capital and excluding potential milestone payments, Organovo expects to maintain operations through FY2026. The company plans to report FY2025 financials around June 6-10, 2025.
Organovo utilizes 3D human cellular models of Crohn's disease and ulcerative colitis to evaluate therapeutic opportunities. In 2024, FXR314 showed promising results in IBD treatment, demonstrating improved epithelial barrier function and fibrotic activity in ulcerative colitis, as well as synergistic benefits when combined with JAK inhibitors. The drug also showed potential in treating liver fibrosis in Phase 2 MASH trials.
Organovo Holdings (NASDAQ:ONVO) has successfully completed the sale of its FXR program, including lead asset FXR314, to Eli Lilly and Company (NYSE:LLY) on March 25, 2025. The transaction includes an upfront payment to Organovo, with additional milestone payments tied to FXR314's regulatory and commercial achievements.
As part of the deal, Lilly acquires worldwide development rights and all commercial and intellectual property rights to Organovo's FXR program. Lilly will assume responsibility for all future clinical development of the program.
Organovo Holdings (ONVO) has announced a 1-for-12 reverse stock split effective March 20, 2025, at 5:00 p.m. Eastern Time. The stock will begin trading on a split-adjusted basis on March 21, 2025, maintaining its Nasdaq symbol 'ONVO' with a new CUSIP number.
The split will reduce outstanding shares from approximately 21.4 million to 1.8 million, with no change to the par value of $0.001 per share or the authorized number of shares. Stockholders with fractional shares will receive cash payments based on the closing price on March 19, 2025.
This strategic move aims to regain compliance with Nasdaq's minimum bid price requirement of $1.00 per share. The split ratio was approved by the board on March 6, 2025, following stockholder authorization granted at the November 20, 2024 annual meeting.
Organovo Holdings (ONVO), a clinical stage biotechnology company focused on inflammatory bowel disease (IBD) treatments, has announced the issuance of 2,967,144 additional shares of common stock through warrant exercises and at-the-market sales.
The share issuance, registered under statements effective May 8, 2024, is expected to generate gross proceeds of approximately $2.3 million, before deducting fees and commissions. Following this issuance, Organovo's total outstanding common stock has reached 20,421,617 shares.
Organovo Holdings (Nasdaq: ONVO) has announced that Eli Lilly and Company (NYSE: LLY) will acquire its FXR program, including lead asset FXR314. This represents a significant milestone for Organovo's efforts to advance medicines for inflammatory bowel disease (IBD) using insights from their proprietary 3D human tissue models.
Under the transaction terms, Organovo will receive an upfront payment and additional milestone payments as FXR314 achieves key regulatory and commercial targets. Lilly is acquiring all commercial and intellectual property rights to Organovo's FXR program for worldwide development.
Keith Murphy, Executive Chairman of Organovo, expressed excitement about delivering FXR314 and the FXR program to Lilly for Phase 2 and further development, citing Lilly's world-class development excellence and dedication to patients as providing an excellent pathway for FXR314's success.
Organovo Holdings (NASDAQ:ONVO) has appointed Norman Staskey as Chief Financial Officer. Staskey, who has worked at Danforth Advisors since 2021, brings over 25 years of experience in capital markets and M&A transactions, including his role as Managing Director in EY's national transactions practice.
The company recently presented Phase 2 results for its lead drug FXR314 in MASH treatment, showing statistically significant reduction in liver fat content with lower pruritus rates compared to other FXR agonists. The study involved 214 patients. Additionally, 2024 data demonstrated FXR314's potential in IBD treatment, showing improved epithelial barrier function and fibrotic activity in ulcerative colitis models, as well as synergistic benefits when combined with JAK inhibitors.
Organovo anticipates a Phase 2 study to demonstrate FXR314's effectiveness in moderate to severe ulcerative colitis, with potential development as both monotherapy and combination therapy.
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.
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