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Janux Therapeutics (JANX) FDA Events

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FDA Events for Janux Therapeutics (JANX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Janux Therapeutics (JANX). Over the past two years, Janux Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as JANX007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

JANX007 - FDA Regulatory Timeline and Events

JANX007 is a drug developed by Janux Therapeutics for the following indication: Metastatic Castration-Resistant Prostate Cancer (mCRPC). 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.

Janux Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Janux Therapeutics (JANX) has reported FDA regulatory activity for JANX007.

The most recent FDA-related event for Janux Therapeutics occurred on May 5, 2025, involving JANX007. The update was categorized as "Study Expansion," with the company reporting: "Janux Therapeutics, Inc. announced the initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial."

Currently, Janux Therapeutics has one therapy (JANX007) targeting the following condition: Metastatic Castration-Resistant Prostate Cancer (mCRPC).

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:JANX) was last updated on 7/9/2025 by MarketBeat.com Staff
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