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Prima BioMed (IMMP) FDA Events

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FDA Events for Prima BioMed (IMMP)

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

Prima BioMed's Drugs in FDA Review

eftilagimod alpha - FDA Regulatory Timeline and Events

eftilagimod alpha is a drug developed by Prima BioMed for the following indication: For cancer and autoimmune 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.

Eftilagimod alpha (efti or IMP321) MBC - FDA Regulatory Timeline and Events

Eftilagimod alpha (efti or IMP321) MBC is a drug developed by Prima BioMed for the following indication: Metastatic Breast Cancer (MBC). 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.

Prima BioMed FDA Events - Frequently Asked Questions

In the past two years, Prima BioMed (IMMP) 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, Prima BioMed (IMMP) has reported FDA regulatory activity for the following drugs: eftilagimod alpha and Eftilagimod alpha (efti or IMP321) MBC.

The most recent FDA-related event for Prima BioMed occurred on May 27, 2025, involving eftilagimod alpha. The update was categorized as "Trial Initiation," with the company reporting: "Immutep Limited announces the investigator-initiated EFTISARC-NEO Phase II trial evaluating eftilagimod alfa (efti) with radiotherapy plus KEYTRUDA® (pembrolizumab) in the neoadjuvant setting for resectable soft tissue sarcoma (STS) has met its primary endpoint."

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

  • For cancer and autoimmune disease - eftilagimod alpha
  • Metastatic Breast Cancer (MBC) - Eftilagimod alpha (efti or IMP321) MBC

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:IMMP) was last updated on 7/11/2025 by MarketBeat.com Staff
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