TRACON Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by TRACON Pharmaceuticals (TCON).
Over the past two years, TRACON Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Uliledlimab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Uliledlimab (TJ004309) FDA Regulatory Events
Uliledlimab (TJ004309) is a drug developed by TRACON Pharmaceuticals for the following indication: Advanced cancer.
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:
- Uliledlimab (TJ004309)
- Announced Date:
- September 10, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- Advanced cancer
Announcement
I-Mab announced that Randomized Phase 2 study of uliledlimab in combination with pembrolizumab plus chemotherapy expected to begin in 1H 2025
AI Summary
I-Mab, a U.S.-based biotech company, announced plans for a randomized Phase 2 trial to evaluate uliledlimab in combination with pembrolizumab and chemotherapy for metastatic non‐small cell lung cancer (mNSCLC). The study is expected to begin in the first half of 2025. This trial builds on promising data from three Phase 1 studies, where pharmacokinetic/pharmacodynamic analyses showed that higher concentrations of uliledlimab were associated with improved overall response rates in mNSCLC patients. The data supported the dose selection strategy by demonstrating strong target engagement and achieving the desired drug exposure levels. I-Mab believes these findings reinforce the potential of uliledlimab to overcome immunosuppression in the tumor environment, paving the way for its next steps in clinical development and offering a promising new therapeutic option for patients with mNSCLC.
Read Announcement- Drug:
- Uliledlimab (TJ004309)
- Announced Date:
- September 10, 2024
- Indication:
- Advanced cancer
Announcement
I-Mab announced a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease (IASLD)'s 2024 World Conference on Lung Cancer (WCLC 2024) held September 7-10, 2024 in San Diego, CA.
AI Summary
I-Mab, a U.S.-based biotech company, has announced that it will present PK/PD modeling data for its CD73 inhibitor, uliledlimab (TJ004309), at the upcoming IASLD 2024 World Conference on Lung Cancer in San Diego, CA, from September 7-10, 2024. The poster presentation details analyses from three Phase 1 studies that provided key dosing insights to support future clinical trials. Notably, the Exposure-Response analysis showed a positive relationship between uliledlimab levels and overall response rates in patients with metastatic non-small cell lung cancer (mNSCLC).
The data also indicated strong target engagement with nearly complete CD73 receptor occupancy and demonstrated dose proportional pharmacokinetics. These positive findings have encouraged further development of uliledlimab as a promising, best-in-class CD73 inhibitor, with additional combination studies, including one with pembrolizumab and chemotherapy, planned to begin in the first half of 2025.
Read Announcement
TRACON Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, TRACON Pharmaceuticals (TCON) has not received any FDA approvals for its therapy in the last two years.
In the past two years, TRACON Pharmaceuticals (TCON) has reported FDA regulatory activity for Uliledlimab (TJ004309).
The most recent FDA-related event for TRACON Pharmaceuticals occurred on September 10, 2024, involving Uliledlimab (TJ004309). The update was categorized as "Poster Presentation," with the company reporting: "I-Mab announced a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease (IASLD)'s 2024 World Conference on Lung Cancer (WCLC 2024) held September 7-10, 2024 in San Diego, CA."
Currently, TRACON Pharmaceuticals has one therapy (Uliledlimab (TJ004309)) targeting the following condition: Advanced cancer.
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Companies With Recent FDA Events
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
FDA progress for NASDAQ:TCON last updated on 6/20/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
