Free Trial

Maravai LifeSciences (MRVI) FDA Events

Maravai LifeSciences logo
$2.90 +0.14 (+4.89%)
Closing price 03:59 PM Eastern
Extended Trading
$2.90 0.00 (0.00%)
As of 04:01 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.
FDA Events for Maravai LifeSciences (MRVI)

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

AccuRes™ - FDA Regulatory Timeline and Events

AccuRes™ is a drug developed by Maravai LifeSciences for the following indication: For the target host cell line as opposed to off-target DNA. 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.

Maravai LifeSciences FDA Events - Frequently Asked Questions

As of now, Maravai LifeSciences (MRVI) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Maravai LifeSciences (MRVI) has reported FDA regulatory activity for AccuRes™.

The most recent FDA-related event for Maravai LifeSciences occurred on August 28, 2024, involving AccuRes™. The update was categorized as "Provided Update," with the company reporting: "Cygnus Technologies (Cygnus), TriLink BioTechnologies (TriLink®), both part of Maravai LifeSciences (NASDAQ:MRVI) have collaborated to launch Cygnus' AccuRes™ Host Cell DNA Quantification Kits."

Currently, Maravai LifeSciences has one therapy (AccuRes™) targeting the following condition: For the target host cell line as opposed to off-target DNA.

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:MRVI) was last updated on 7/10/2025 by MarketBeat.com Staff
From Our Partners