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Immuneering (IMRX) FDA Events

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FDA Events for Immuneering (IMRX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Immuneering (IMRX). Over the past two years, Immuneering has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IMM-1-104. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

IMM-1-104 - FDA Regulatory Timeline and Events

IMM-1-104 is a drug developed by Immuneering for the following indication: Solid tumors. 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.

Immuneering FDA Events - Frequently Asked Questions

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

In the past two years, Immuneering (IMRX) has reported FDA regulatory activity for IMM-1-104.

The most recent FDA-related event for Immuneering occurred on June 17, 2025, involving IMM-1-104. The update was categorized as "Positive Data," with the company reporting: "Immuneering Corporation announced positive data from its ongoing Phase 2a clinical trial evaluating atebimetinib (IMM-1-104), an oral, once-daily novel MEK inhibitor, in combination with modified gemcitabine/nab-paclitaxel (mGnP) in first-line pancreatic cancer patients."

Currently, Immuneering has one therapy (IMM-1-104) targeting the following condition: Solid tumors.

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:IMRX) was last updated on 7/10/2025 by MarketBeat.com Staff
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