FDA Events for Organovo (ONVO)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Organovo (ONVO).
Over the past two years, Organovo has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
FXR314. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
FXR314 - FDA Regulatory Timeline and Events
FXR314 is a drug developed by Organovo for the following indication: Treatment of ulcerative colitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- FXR314
- Announced Date:
- November 20, 2024
- Indication:
- Treatment of ulcerative colitis
Announcement
Organovo Holdings, Inc. 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).
AI Summary
Organovo Holdings, Inc. announced that its lead clinical stage drug FXR314 was featured during an oral presentation at The Liver Meeting, sponsored by the American Association for the Study of Liver Diseases (AASLD). The presentation was led by Dr. Eric Lawitz of the Texas Liver Institute and the University of Texas Health San Antonio, highlighting the results from a Phase 2 study focused on FXR314 in treating metabolic dysfunction-associated steatohepatitis (MASH).
In his talk, Dr. Lawitz detailed how the 16-week, randomized, placebo-controlled study showed significant reductions in liver fat among MASH patients treated with FXR314. He underscored the drug’s promising efficacy and safety profile, noting that FXR314 achieved liver fat reductions without the common side effects seen in other FXR agonists. This finding positions the drug as a potential novel treatment for liver disease.
Read Announcement- Drug:
- FXR314
- Announced Date:
- April 15, 2024
- Indication:
- Treatment of ulcerative colitis
Announcement
Organovo Holdings, 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).
AI Summary
Organovo Holdings recently released full details of its 16‑week, randomized, placebo-controlled, multi-center Phase 2 clinical study evaluating FXR314 for the treatment of metabolic function-associated steatohepatitis (MASH). The study focused on a non-steroidal, non‑bile acid FXR agonist and showed statistically significant results. Patients treated with FXR314 experienced a marked reduction in liver fat content compared to the placebo group. Specifically, those receiving a 3 mg dose saw an average liver fat reduction of 22.8%, while the 6 mg dose led to a 17.5% reduction, compared with a 6.1% decrease in the placebo group. Additionally, a larger percentage of patients on FXR314 achieved over 30% reduction in liver fat as measured by MRI. The treatment was also found to be safe and well tolerated, with mild-to-moderate adverse events and no significant issues related to pruritus or liver fibrosis.
Read Announcement
Organovo FDA Events - Frequently Asked Questions
As of now, Organovo (ONVO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Organovo (ONVO) has reported FDA regulatory activity for FXR314.
The most recent FDA-related event for Organovo occurred on November 20, 2024, involving FXR314. The update was categorized as "Oral presentation," with the company reporting: "Organovo Holdings, Inc. 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)."
Currently, Organovo has one therapy (FXR314) targeting the following condition: Treatment of ulcerative colitis.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:ONVO) was last updated on 7/12/2025 by MarketBeat.com Staff
