Company Overview - Organovo Holdings, Inc. is a clinical stage biotechnology company focused on developing novel treatment approaches for inflammatory bowel disease (IBD), including ulcerative colitis [1][3] - The company utilizes proprietary technology to create three-dimensional (3D) human tissues that replicate key aspects of native human tissue [3] Product Development - The lead molecule, FXR314, is currently advancing towards Phase 2 investigation for IBD and has potential applications in metabolic liver disease and oncology [3] - The company aims to demonstrate the efficacy of FXR314 in its Phase 2a trial, building on strong preclinical results and promising data from 3D human models of ulcerative colitis and Crohn's disease [2] Market Context - The market for IBD treatments is active, with significant mergers and acquisitions, exemplified by Lilly's acquisition of Morphic for $3.2 billion following strong Phase 2a results [2] - The company is optimistic about its near-term opportunities to showcase the value of FXR314 in the competitive landscape of IBD treatments [2]

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/18487 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from to Commission File No. 001-35996 ORGANOVO HOLDINGS, INC. (Exact name of registrant as specified in its charter) Delaware 27-1488943 (State or other jurisdiction of in ...

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 m ...

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 m ...

SAN DIEGO, May 14, 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 it will be presenting data on the Company's lead clinical-stage drug, FXR314 during DDW2024, which is being held in Washington, D.C. May 18-21, 2024. Contact CORE IR pr@coreir.com Source: Organovo, Inc. The poster, titled, "Combination therapy of the FXR agon ...

SAN DIEGO, May 14, 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 it will be presenting data on the Company's lead clinical-stage drug, FXR314 during DDW2024, which is being held in Washington, D.C. May 18-21, 2024. The poster, titled, "Combination therapy of the FXR agonist FXR314 with tofacitinib in models of inflammatory ...

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 ...

As filed with the Securities and Exchange Commission on April 30, 2024 Registration No. 333-278668 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2836 27-1488943 (Primary Standard Classification Code Number) 11555 Sorrento Valley Road, Suite 100 (I.R.S ...

As filed with the Securities and Exchange Commission on April 12, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Organovo Holdings, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Classification Code Number) 11555 Sorrento Valley Road, Suite 100 San Diego, CA 92121 (858) 224-1000 Delaware 2836 27-1488943 (I.R.S. Employer I ...