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.
- Drug:
- JANX007
- Announced Date:
- May 5, 2025
- Indication:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Announcement
Janux Therapeutics, Inc. announced the initiation of Phase 1b expansion studies in the ongoing ENGAGER-PSMA-01 trial.
AI Summary
Janux Therapeutics, Inc. announced that it has begun Phase 1b expansion studies in its ENGAGER-PSMA-01 trial. This trial is the first in human and is an open-label, multicenter study. It evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and early efficacy of JANX007 in patients with advanced metastatic castration-resistant prostate cancer (mCRPC).
The new Phase 1b study focuses on taxane-naïve mCRPC patients, aiming to generate extra data for this first and second line group. In this study, JANX007 will be given as a monotherapy at two different dosing regimens, either once a week or every two weeks, after patients have progressed on novel hormonal therapy. The decision to move into earlier lines of treatment comes after promising results from the previous Phase 1a study, where patients showed a median radiographic progression-free survival of about 7.5 months.
Read Announcement- Drug:
- JANX007
- Announced Date:
- February 27, 2025
- Indication:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Announcement
Janux Therapeutics, Inc provided a business update.
AI Summary
Janux Therapeutics, Inc., a clinical-stage biopharmaceutical company, provided a business update highlighting its progress in 2024. The company presented positive interim Phase 1 clinical trial data for its PSMA-TRACTr candidate, JANX007, in patients with metastatic castration-resistant prostate cancer. The data showed strong PSA response rates and promising anti-tumor activity, which supports plans to pursue earlier lines of treatment in the future.
Enrollment is ongoing for both JANX007 and its second candidate, JANX008, in their respective Phase 1 studies. The company expects to update its clinical data and reveal new programs during its R&D Day planned for 2025. Financially, Janux reported $1.03 billion in cash, cash equivalents, and short-term investments. The update highlights a robust financial base supporting strong clinical progress, and Janux remains committed to moving its TRACTr platform forward.
Read Announcement- Drug:
- JANX007
- Announced Date:
- December 2, 2024
- Indication:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Announcement
Janux Therapeutics, Inc announced positive updated interim clinical data for its JANX007 clinical program.
AI Summary
Janux Therapeutics, Inc. announced positive updated interim clinical data for its JANX007 clinical program in patients with metastatic castration-resistant prostate cancer. In the study, all 16 patients demonstrated at least a 50% reduction in PSA levels, with many showing deeper and durable declines in PSA, an important marker in prostate cancer treatment. Specifically, 63% of patients achieved a 90% decline, and 31% reached a 99% decline in PSA levels. Additionally, 75% maintained a 50% decline and 50% maintained a 90% decline for at least 12 weeks. The study also showed encouraging anti-tumor activity with a 50% overall response rate and a 63% disease control rate in evaluable patients. Importantly, JANX007 was well-tolerated, with adverse events mostly limited to the first treatment cycle and being mild to moderate in severity.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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 7/12/2025 by MarketBeat.com Staff
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