Free Trial

Immunic (IMUX) FDA Events

Immunic logo
$0.83 -0.01 (-1.05%)
As of 02:38 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.
FDA Events for Immunic (IMUX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Immunic (IMUX). Over the past two years, Immunic has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IMU-838, IMU-838, IMU-838, IMU-856, and Vidofludimus. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Immunic's Drugs in FDA Review

IMU-838 - FDA Regulatory Timeline and Events

IMU-838 is a drug developed by Immunic for the following indication: In Patients with Post COVID Syndrome (RAPID­­_REVIVE).". 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.

IMU-838 (CALLIPER) - FDA Regulatory Timeline and Events

IMU-838 (CALLIPER) is a drug developed by Immunic for the following indication: Progressive multiple sclerosis (PMS). 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.

IMU-838 (EMPhASIS) - FDA Regulatory Timeline and Events

IMU-838 (EMPhASIS) is a drug developed by Immunic for the following indication: Relapsing-remitting multiple sclerosis. 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.

IMU-856 - FDA Regulatory Timeline and Events

IMU-856 is a drug developed by Immunic for the following indication: Celiac disease. 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.

Vidofludimus - FDA Regulatory Timeline and Events

Vidofludimus is a drug developed by Immunic for the following indication: For patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. 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.

Immunic FDA Events - Frequently Asked Questions

In the past two years, Immunic (IMUX) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Immunic (IMUX) has reported FDA regulatory activity for the following drugs: IMU-838, Vidofludimus, IMU-838 (EMPhASIS), IMU-838 (CALLIPER) and IMU-856.

The most recent FDA-related event for Immunic occurred on June 24, 2025, involving IMU-838 (EMPhASIS). The update was categorized as "Data," with the company reporting: "Immunic, Inc. reported new long-term open-label extension (OLE) data from its phase 2 EMPhASIS trial of lead asset, orally available nuclear receptor-related 1 (Nurr1) activator, vidofludimus calcium (IMU-838), in patients with relapsing-remitting multiple sclerosis (RRMS)."

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

  • In Patients with Post COVID Syndrome (RAPID­­_REVIVE)." - IMU-838
  • For patients with multiple sclerosis and other chronic inflammatory and autoimmune diseases. - Vidofludimus
  • Relapsing-remitting multiple sclerosis - IMU-838 (EMPhASIS)
  • Progressive multiple sclerosis (PMS) - IMU-838 (CALLIPER)
  • Celiac disease - IMU-856

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:IMUX) was last updated on 7/11/2025 by MarketBeat.com Staff
From Our Partners