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INmune Bio (INMB) FDA Events

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FDA Events for INmune Bio (INMB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by INmune Bio (INMB). Over the past two years, INmune Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AD02, CORDStrom, INB03, INKmune, XPro, and XPro1595. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

INmune Bio's Drugs in FDA Review

AD02 - FDA Regulatory Timeline and Events

AD02 is a drug developed by INmune Bio for the following indication: For Alzheimer 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.

CORDStrom - FDA Regulatory Timeline and Events

CORDStrom is a drug developed by INmune Bio for the following indication: For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB). 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.

INB03 - FDA Regulatory Timeline and Events

INB03 is a drug developed by INmune Bio for the following indication: INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα. 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.

INKmune - FDA Regulatory Timeline and Events

INKmune is a drug developed by INmune Bio for the following indication: High-Risk Myelodysplastic Syndrome (MDS). 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.

XPro - FDA Regulatory Timeline and Events

XPro is a drug developed by INmune Bio for the following indication: For treatment of Alzheimer's 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.

XPro1595 - FDA Regulatory Timeline and Events

XPro1595 is a drug developed by INmune Bio for the following indication: Alzheimer’s 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.

INmune Bio FDA Events - Frequently Asked Questions

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

In the past two years, INmune Bio (INMB) has reported FDA regulatory activity for the following drugs: XPro, INKmune, CORDStrom, AD02, XPro1595 and INB03.

The most recent FDA-related event for INmune Bio occurred on June 30, 2025, involving XPro. The update was categorized as "Findings Update," with the company reporting: "INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro™ in Early Alzheimer's Disease"

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

  • For treatment of Alzheimer's Disease - XPro
  • High-Risk Myelodysplastic Syndrome (MDS) - INKmune
  • For Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) - CORDStrom
  • For Alzheimer Disease - AD02
  • Alzheimer’s disease - XPro1595
  • INB03 is an Innate Immune Check Point Inhibitor that Downregulates SIRPα - INB03

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