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
JANX008 and JANX007. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
JANX008 FDA Regulatory Events
JANX008 is a drug developed by Janux Therapeutics for the following indication: multiple solid tumor indications.
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:
- JANX008
- Announced Date:
- April 27, 2026
- Indication:
- multiple solid tumor indications.
Announcement
Janux Therapeutics, Inc announced that it will discontinue further clinical development of JANX008, its EGFR-targeted Tumor Activated T Cell Engager (TRACTr) program.
AI Summary
Janux Therapeutics announced it will stop further clinical development of JANX008, its EGFR-targeted Tumor Activated T Cell Engager (TRACTr) program. JANX008 was designed to target EGFR on tumor cells and engage T cells to attack those tumors, but the company has decided not to advance it into later studies.
Janux said the decision reflects a disciplined review of its pipeline. Company leadership evaluates programs on safety, activity, and a differentiated profile. If a program does not meet the high standards set for those measures, Janux will reallocate resources to other candidates that show stronger potential to produce best-in-class outcomes.
The company will continue developing other programs across its TRACTr, TRACIr, and ARM platforms, including ongoing work on different candidates such as JANX011, while prioritizing resources toward projects with the most promising risk‑benefit profiles.Read Announcement
- Drug:
- JANX008
- Announced Date:
- December 23, 2025
- Indication:
- multiple solid tumor indications.
Announcement
Janux Therapeutics, Inc provided a program update on its ongoing Phase 1 study evaluating JANX008, its EGFR-targeted TRACTr, in multiple solid tumor indications.
Read Announcement
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:
- December 1, 2025
- Indication:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Announcement
Janux Therapeutics, Inc. announced positive updated interim data for its JANX007, a PSMA-directed TRACTr, Phase 1 clinical program in patients with mCRPC. Janux will host a virtual event on Monday, December 1, 2025, at 4:30 PM ET.
AI Summary
Janux Therapeutics reported positive updated interim Phase 1 data for JANX007, its PSMA-directed TRACTr for metastatic castration-resistant prostate cancer (mCRPC). As of the October 15, 2025 cutoff, 109 patients had been treated across dose-escalation and expansion cohorts. Patients showed high PSA response rates, deep PSA declines and anti-tumor activity with confirmed and unconfirmed partial responses in 30% (8/27) of RECIST-evaluable patients.
Durability was encouraging, with radiographic progression-free survival (rPFS) of 7.9–8.9 months across weekly (QW) and every-two-week (Q2W) dosing cohorts; the Q2W group compared favorably to QW and supports a patient-friendly Q2W schedule. Preliminary Phase 1b taxane-naïve data showed rapid, deep PSA reductions and mainly grade 1 cytokine release syndrome (CRS). CRS was generally limited to cycle 1 and remained manageable with a mitigation strategy.
Janux is advancing JANX007 as monotherapy and in combination studies and will host a virtual investor webcast on Monday, December 1, 2025, at 4:30 PM ET with a live Q&A and replay on its investors page.
Read Announcement- Drug:
- JANX007
- Announced Date:
- July 24, 2025
- Indication:
- Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Announcement
Janux Therapeutics, Inc. a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technologies to its Tumor Activated T Cell Engager (TRACTr), Tumor Activated Immunomodulator (TRACIr), and Adaptive Immune Response Modulator (ARM) platforms, will host its virtual R&D Day today at 1:30 PM PT. The event will highlight the company's continued momentum in advancing its novel immunotherapy platforms—TRACTr and TRACIr, as well as ARM—designed to address significant unmet needs in oncology and autoimmune diseases.
AI Summary
Janux Therapeutics, a clinical-stage biopharma company developing a pipeline of novel immunotherapies using its proprietary TRACTr, TRACIr, and ARM platforms, will host a virtual R&D Day today at 1:30 PM PT. The event will highlight Janux’s progress in cancer and autoimmune immunotherapies.
The TRACIr platform, built on Janux’s tumor-activated design, is planned to combine with JANX007 (PSMA-TRACTr) to enhance T-cell activation and durability. IND-enabling studies support trials in late 2026.
The TRACTr program targeting TROP2 offers a first-in-class and best-in-class opportunity, demonstrating strong potency, favorable safety, and a wide therapeutic window across multiple solid tumors in preclinical tests.
The ARM platform’s CD19-ARM achieved rapid, deep B-cell depletion with a large safety margin in primate studies. First-in-human trials are set for early 2026.
This R&D Day highlights Janux’s momentum in advancing TRACTr, TRACIr, and ARM platforms for oncology and autoimmune care.
Read Announcement- 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
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