Organovo Hlds

Organovo Holdings, Inc. is engaged in the development of bioprinted human tissues that emulate human biology and disease. Its three-dimensional human tissue platform is enabled by its proprietary NovoGen Bioprinters and related technologies for preparing bio-inks and bioprinting multicellular tissues with complex architecture. The company was founded on January 30, 2012 and is headquartered in San Diego, CA.

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Organovo Holdings said on Monday its experimental drug to treat a type of fatty liver disease met the main goal in a mid-stage study, sending its shares up nearly 27% in premarket trade.

Organovo's fatty liver disease drug meets main goal in mid-stage study

Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Conte

Organovo Announces Positive Phase 2 Results for FXR314 in Metabolic Dysfunction-Associated Steatohepatitis (MASH) Showing Both Reduction in Liver Fat Content and Strong Safety and Tolerability Compared to Placebo

SAN DIEGO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), a clinical stage biotechnology company focused on developing FXR314 in inflammatory bowel disease (IBD), including ulcerative colitis, based on demonstration of clinical promise in three-dimensional (3D) human tissues, today announced the presentation of preclinical data related to the company's FXR314 development program in its proprietary 3D human tissue models of Crohn's disease and ulcerative colitis at the Crohn's and Colitis Congress being held January 25-27, 2024 in Las Vegas, Nevada.

Organovo Presents FXR314 3D Human Tissue Model Findings That Show Improved Epithelial Barrier Function and Fibrosis Reduction at Crohn's and Colitis Congress

SAN DIEGO, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage biotechnology company that is focused on developing FXR314 in inflammatory bowel disease (IBD), including ulcerative colitis (UC), based on demonstration of clinical promise in three-dimensional (3D) human tissues as well as strong preclinical data, today announced that its data on the activity of FXR314 in its proprietary 3D human tissue models of Crohn's disease and ulcerative colitis will be presented at the Crohn's and Colitis Congress to be held January 25-27, 2024 in Las Vegas, Nevada.

Organovo To Present FXR314 IBD 3D Model Findings at Upcoming Crohn's and Colitis Congress

SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage biotechnology company that is focused on developing FXR314 in ulcerative colitis and inflammatory bowel disease (IBD), based on demonstration of clinical promise in three-dimensional (3D) human tissues as well as strong preclinical data, today announced that it will release final and complete data from a Phase 2a trial of FXR314 in non-alcoholic steatohepatitis (NASH) patients by April 2024. The Company anticipates presentations at scientific meetings as well as publication in peer-reviewed journals. The release of this data will be the first public release of the completed clinical trial data.

Organovo Provides Timing for Release of FXR314 Phase 2 NASH Results

SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline on November 8, 2023 by Organovo, Inc. (NASDAQ: ONVO), a link was incorrect. The corrected release follows:

CORRECTION – Organovo Highlights FXR314 Combination Therapy Potential and Plan

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ: ONVO), a clinical stage biotechnology company that is focused on developing FXR314 in ulcerative colitis and inflammatory bowel disease (IBD), based on demonstration of clinical promise in three-dimensional (3D) human tissues as well as strong preclinical data, today announced its intention to study combination therapy in inflammatory bowel disease and release data in calendar Q3 2024. The Company believes that the data it can generate can be powerful in establishing a strong use case for FXR314 in patients, and provide support for collaborations with major pharmaceutical companies currently offering IBD treatments.

Organovo Highlights FXR314 Combination Therapy Potential and Plan

SAN DIEGO, Sept. 08, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (Organovo), a clinical stage biotechnology company that is focused on developing novel human therapies with high fidelity in three-dimensional (3D) human tissues that recapitulate key aspects of human disease, today announced that Keith Murphy, Founder and Executive Chairman, will present a corporate update and hold meetings with institutional investors during the H.C. Wainwright 25th Annual Global Investment Conference being held September 11-13, 2023.

Organovo to Participate in the H.C. Wainwright Global Investment Conference

SAN DIEGO, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (Organovo), a clinical stage biotechnology company that is focused on developing novel human therapies with demonstrated function in high fidelity three-dimensional (3D) tissues that recapitulate key aspects of human disease, today announced more details about its clinical program for FXR314, an FXR agonist that has completed initial clinical trials. FXR314 is a drug with safety and tolerability after daily oral dosing in Phase 1 and Phase 2 trials. Further, FXR314 has FDA clinical trial authorization for a Phase 2 trial in ulcerative colitis.

Organovo Advances Clinical Timelines for FXR314 and Provides Updates on NASH Phase 2 Data

Lead Molecule Poised for Phase 2 in IBD Lead Molecule Poised for Phase 2 in IBD

Organovo Announces FXR Program

SAN DIEGO, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), a three-dimensional biology (3D biology) company focused on delivering scientific and medical breakthroughs using novel technologies including 3D bioprinting, today announced that it has successfully advanced the use of its first inflammatory bowel disease (IBD) model and has achieved the next milestone, target validation. The company announced in May 2022 that it had achieved a successful Crohn's disease model that demonstrates key aspects of patient biology that differ from a non-diseased state and that the model would be used to find and characterize therapeutics. The Crohn's disease model has since been utilized to understand the biology of disease and identify specific gene targets. Treating some of those targets, by introducing a compound directly to the 3D tissue model that affects the target, has now been shown to reproducibly reduce disease. Multiple targets are now considered validated, and they represent specific druggable opportunities that the company plans to leverage. Organovo plans to advance at least one target program to medicinal chemistry by the end of 2022 to build a proprietary new drug for Crohn's disease.

Organovo Announces Target Validation Ahead of Schedule, Accelerating Timeline for First Crohn's Disease Drug Candidates

SAN DIEGO, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQ: ONVO), an early-stage biotechnology company that is focusing on building high fidelity, 3D tissues that recapitulate key aspects of human disease, today announced that Keith Murphy, Executive Chairman, will participate in the H.C. Wainwright 24th Annual Global Investment Conference, September 12 - 14, 2022.

Organovo to Participate in the H.C. Wainwright 24th Annual Global Investment Conference

SAN DIEGO, Sept. 06, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), an early-stage biotechnology company that is focusing on building high fidelity, 3D tissues that recapitulate key aspects of human disease (the “Company”), today announced that its 2022 Annual Meeting of Stockholders (the “2022 Annual Meeting”) that was scheduled to be held at 9:00AM (Pacific Time) on Wednesday, September 7, 2022 has been postponed to October 12, 2022 at 9:00AM (Pacific Time), a date determined by the Company's board of directors. The Company's board of directors also established a new record date for the 2022 Annual Meeting, and based on this record date, the Company will deliver a new notice of the 2022 Annual Meeting to stockholders entitled to receive notice of such meeting. The new record date for the 2022 Annual Meeting is September 7, 2022. The 2022 Annual Meeting will still be conducted virtually via live webcast at www.virtualshareholdermeeting.com/ONVO2022.

Organovo Announces Postponement of Annual Meeting of Stockholders

SAN DIEGO, May 17, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), a three-dimensional (3D) biology company focused on delivering scientific and medical breakthroughs using novel technologies including 3D bioprinting, today announces that it has successfully advanced its first inflammatory bowel disease (IBD) model to the next step of target discovery and validation for Crohn's disease.   Based on its internal data and scientific results, the company believes that its first IBD model correctly demonstrates key aspects of Crohn's patient biology that differ from a non-diseased state, and can be used to find and characterize therapeutics.

Organovo Achieves 3D Tissue Model for Crohn's Disease

The company's licensing agreement with a Swedish company means an infusion of some much-needed cash for Organovo.

Why Organovo Holdings, Inc. Stock Soared 49.7% This Week

SAN DIEGO, March 01, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), and BICO (OTCPK: CLLKF, Nasdaq Stockholm: BICO.ST) announced they have reached agreement on a broad license for BICO and its affiliate companies to Organovo's foundational patent portfolio in 3D bioprinting. Founded in 2016, BICO (formerly Cellink) is the leading bio convergence company in the world. Cellink continues to operate as a wholly owned division of BICO.

UPDATE -- Organovo and BICO (CELLINK) Reach Licensing Agreement on Bioprinting Patents

SAN DIEGO, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), and BICO today announced they have reached agreement on a broad license for BICO and its affiliate companies to Organovo's foundational patent portfolio in 3D bioprinting. Founded in 2016, BICO (formerly Cellink) is the leading bio convergence company in the world. Cellink continues to operate as a wholly owned division of BICO.

Organovo and BICO (CELLINK) Reach Licensing Agreement on Bioprinting Patents

SAN DIEGO, Feb. 18, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (“Organovo”), today announced that it has granted a stock option to purchase 50,000 shares of common stock to one new employee. The stock option was granted pursuant to the Organovo Holdings, Inc. 2021 Inducement Equity Incentive Plan and granted as an inducement material to the new employee entering into employment with Organovo in accordance with Nasdaq Listing Rule 5635(c)(4).

Organovo Holdings, Inc. Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4)

SAN DIEGO, Feb. 18, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), a three-dimensional biology company focused on delivering scientific and medical breakthroughs using 3D bioprinting technology, today announced the hiring of Curtis Tyree, PhD, as Sr. Vice President of Strategy and Business Development. Dr. Tyree has more than 20 years of management and R&D experience in the drug discovery industry in a variety of therapeutic areas at Ligand Pharmaceuticals, TorreyPines Therapeutics (previously Neurogenetics) and most recently served as SVP, Strategic Planning at HUYABIO International.

Organovo Welcomes New Sr. Vice President of Strategy and Business Development

SAN DIEGO, Feb. 02, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), today announced that two of its patents have withstood a patent challenge, and the company provided guidance on how it expects to leverage its strong patent portfolio. Organovo holds a powerful foundational patent portfolio in the 3D bioprinting space due to its licensing of pioneering work in the field and early innovations beyond that start. Organovo is focused today on bringing inflammatory bowel disease (IBD) drugs to market, with multiple IND filings expected by 2025. However, the company plans to utilize licensing revenue from its patent strength to help fund development costs of new drugs.

Organovo Guides on Patent Portfolio and Successful IPR Defense of Two Patents

SAN DIEGO, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), today released its first detailed response to the lawsuit Cellink (NASDAQ Stockholm: BICO) filed against it in Delaware court in 2021. At issue in this lawsuit is whether Cellink is infringing Organovo patents. Organovo, as one of the earliest and most prominent 3D bioprinting companies, has built a strong and foundational patent portfolio in the space. Organovo believes that Cellink, as a newer company with limited patent filings, has moved forward without regard to its patents and now is at risk of owing significant license fees and royalties to Organovo.

Organovo Files Counterclaims In Patent Lawsuit Brought Against It by CellInk

SAN DIEGO, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), today provided a business overview and progress update, and announced it is on track to establish its first models of inflammatory bowel disease in 2022 using its 3D bioprinting and other 3D tissue technologies.

Organovo On Track to Establish Human 3D Disease Model in Inflammatory Bowel Disease in 2022

SOLANA BEACH, Calif., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO), today announced that the Company's annual meeting of shareholders, on September 14, 2021, at 9:00 a.m. was convened and adjourned, without any business being conducted, due to lack of the required quorum.

Organovo Announces Adjournment of Annual Meeting of Shareholders Due to Lack of Quorum

Organovo Holdings, Inc. is an early-stage biotechnology company developing and utilizing highly customized 3D human tissues as dynamic models of health and diseased human biology for internal drug development. Organovo is transitioning its short-term offering from a heavily service-based business in 2019 to drug candidate development, projecting multiple INDs by 2025.

Organovo: New Strategy Targeting Internal Pipeline Development With Customized 3D Human Tissues Offers Upside

Syros Pharmaceuticals

Catherine Wood ( Trades , Portfolio )'s ARK Investment Management has revealed a large reduction in the Organovo Holdings Inc. (NASDAQ:ONVO) position alongside a small reduction in the Syros Pharmaceuticals Inc. (NASDAQ:SYRS) position according to GuruFocus' Real-Time Picks, a Premium feature.

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