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Inventiva (IVA) FDA Events

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FDA Events for Inventiva (IVA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Inventiva (IVA). Over the past two years, Inventiva has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Lanifibranor and NATiV3. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Inventiva's Drugs in FDA Review

Lanifibranor - FDA Regulatory Timeline and Events

Lanifibranor is a drug developed by Inventiva for the following indication: Nonalcoholic steatohepatitis (NASH). 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.

NATiV3 - FDA Regulatory Timeline and Events

NATiV3 is a drug developed by Inventiva for the following indication: In adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis. 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.

Inventiva FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Inventiva (IVA) has reported FDA regulatory activity for the following drugs: Lanifibranor and NATiV3.

The most recent FDA-related event for Inventiva occurred on July 2, 2025, involving Lanifibranor. The update was categorized as "Publication," with the company reporting: "Inventiva announces the publication in Journal of Hepatology Reports, a peer-reviewed, scientific journal, of results from the Phase 2b NATIVE clinical trial and preclinical study evaluating the effects of lanifibranor on liver sinusoidal endothelial cells in Metabolic dysfunction-associated steatotic liver disease ("MASLD") and MASH."

Current therapies from Inventiva in review with the FDA target conditions such as:

  • Nonalcoholic steatohepatitis (NASH) - Lanifibranor
  • In adult patients with biopsy-proven non-cirrhotic NASH and F2/F3 stage of liver fibrosis. - NATiV3

More FDA Event Resources from MarketBeat

  • 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:IVA) was last updated on 7/9/2025 by MarketBeat.com Staff
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