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Articles from Organovo, Inc.

Organovo’s FXR Program, including FXR314, to Be Acquired by Eli Lilly and Company
SAN DIEGO, Feb. 25, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) today announced that Eli Lilly and Company (NYSELLY) (“Lilly”) will acquire Organovo’s FXR program, including its lead asset, FXR314.
By Organovo, Inc. · Via GlobeNewswire · February 25, 2025
Organovo Announces Appointment of Norman Staskey as Chief Financial Officer
SAN DIEGO, Jan. 06, 2025 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announced that it had appointed Norman Staskey as Chief Financial Officer.
By Organovo, Inc. · Via GlobeNewswire · January 6, 2025
Organovo Presents Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting
SAN DIEGO, Nov. 20, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces that its oral presentation of its lead clinical stage drug FXR314 by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio was featured at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The meeting was held November 15-19, 2024 in San Diego, California.
By Organovo, Inc. · Via GlobeNewswire · November 20, 2024
Organovo to Present Clinical Data of FXR314 in Phase 2 MASH in an Oral Presentation at The Liver Meeting Sponsored by the American Association for the Study of Liver Diseases
SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today 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, by Dr. Eric Lawitz of the Texas Liver Institute, will describe the findings from the FXR314 Phase 2 MASH study. The meeting will be held November 15-19, 2024 in San Diego, California.
By Organovo, Inc. · Via GlobeNewswire · November 13, 2024
Organovo Highlights FXR314 Near Term Value Catalysts at Jones Trading Conference Strong Preclinical and Human Rationale for FXR314 in P2 2 Ulcerative Colitis
SAN DIEGO, July 16, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announced that Executive Chairman Keith Murphy presented on the company’s near and long-term outlook, operational plans, at the Jones Trading Healthcare Conference in Encinitas, CA. The webcast was recorded and can be viewed at https://wsw.com/webcast/jones/onvo/1848798.
By Organovo, Inc. · Via GlobeNewswire · July 16, 2024
Organovo Data Presented at Digestive Disease Week (DDW2024) Demonstrating Potential for FXR314 as Combination Therapy with Tofacitinib for Inflammatory Bowel Disease
SAN DIEGO, May 21, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches in inflammatory bowel disease (IBD) including ulcerative colitis, today announces data from a poster presented at Digestive Disease Week (DDW2024) demonstrating the potential of the Company’s lead clinical-stage compound, FXR314, in combination with tofacitinib for treating inflammatory bowel disease (IBD) using 3D models and preclinical models. DDW2024 is being held in Washington, D.C. May 18-21, 2024.
By Organovo, Inc. · Via GlobeNewswire · May 21, 2024
Organovo to Present Data on FXR314 at Digestive Diseases Week (DDW2024)
Renowned gastrointestinal diseases conference to held in Washington, D.C. May 18-21, 2024
By Organovo, Inc. · Via GlobeNewswire · May 14, 2024
Organovo Holdings, Inc. Announces Pricing of $5.25 Million Public Offering
SAN DIEGO, May 08, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq: ONVO) (“Organovo” or the “Company”), a clinical stage biotechnology company focused on developing novel treatment approaches based on demonstration of clinical promise in three-dimensional (3D) human tissues, today announced the pricing of a public offering consisting of 6,562,500 shares of common stock (or pre-funded warrants in lieu thereof) and common warrants to purchase up to an aggregate of 6,562,500 shares of its common stock, at a combined public offering price per share of common stock and accompanying common warrant to purchase one share of common stock of $0.80 (or $0.799 per share subject to pre-funded warrants and accompanying warrant to purchase one share of common stock).
By Organovo, Inc. · Via GlobeNewswire · May 8, 2024
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, April 15, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (Nasdaq:ONVO), a clinical stage biotechnology company focused on developing novel treatment approaches based on demonstration of clinical promise in three-dimensional (3D) human tissues, today released the complete details of its 16-week, randomized, placebo-controlled, multi-center Phase 2 study of the non-steroidal, non-bile acid FXR agonist FXR314 for the treatment of metabolic function-associated steatohepatitis (MASH). Study results demonstrated statistically significant reduction in liver fat content from baseline in patients receiving FXR314 compared to placebo.
By Organovo, Inc. · Via GlobeNewswire · April 15, 2024
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. 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.
By Organovo, Inc. · Via GlobeNewswire · January 25, 2024
Organovo To Present FXR314 IBD 3D Model Findings at Upcoming Crohn’s and Colitis Congress
SAN DIEGO, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQONVO), 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.
By Organovo, Inc. · Via GlobeNewswire · January 9, 2024
Organovo Provides Timing for Release of FXR314 Phase 2 NASH Results
SAN DIEGO, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQONVO), 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.
By Organovo, Inc. · Via GlobeNewswire · December 6, 2023
CORRECTION – Organovo Highlights FXR314 Combination Therapy Potential and Plan
SAN DIEGO, Nov. 13, 2023 (GLOBE NEWSWIRE) -- In a release issued under the same headline on November 8, 2023 by Organovo, Inc. (NASDAQONVO), a link was incorrect. The corrected release follows:
By Organovo, Inc. · Via GlobeNewswire · November 13, 2023
Organovo Highlights FXR314 Combination Therapy Potential and Plan
SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Organovo Holdings, Inc. (NASDAQONVO), 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.
By Organovo, Inc. · Via GlobeNewswire · November 8, 2023
Organovo to Participate in the H.C. Wainwright Global Investment Conference
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.
By Organovo, Inc. · Via GlobeNewswire · September 8, 2023
Organovo Advances Clinical Timelines for FXR314 and Provides Updates on NASH Phase 2 Data
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.
By Organovo, Inc. · Via GlobeNewswire · August 23, 2023
Organovo Announces FXR Program
Lead Molecule Poised for Phase 2 in IBD
By Organovo, Inc. · Via GlobeNewswire · March 21, 2023
Organovo Announces Target Validation Ahead of Schedule, Accelerating Timeline for First Crohn’s Disease Drug Candidates
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.
By Organovo, Inc. · Via GlobeNewswire · November 15, 2022