This company has been marked as potentially delisted and may not be actively trading. TRACON Pharmaceuticals (TCON) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisDividendFDA EventsTrendsBuy This Stock TRACON Pharmaceuticals' Drug in the FDA Approval ProcessThis 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. Provided Update - September 10,2024Provided Update Phase 2Drug: Uliledlimab (TJ004309)Announced Date: September 10, 2024Target Action Date: H1 2025Estimated Target Date Range: January 1, 2025 - June 30, 2025Indication: Advanced cancerAnnouncementI-Mab announced that Randomized Phase 2 study of uliledlimab in combination with pembrolizumab plus chemotherapy expected to begin in 1H 2025AI SummaryI-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 AnnouncementPoster Presentation - September 10,2024Poster Presentation Drug: Uliledlimab (TJ004309)Announced Date: September 10, 2024Indication: Advanced cancerAnnouncementI-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 SummaryI-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 Has TRACON Pharmaceuticals received FDA approval? As of now, TRACON Pharmaceuticals (TCON) has not received any FDA approvals for its therapy in the last two years. What drugs has TRACON Pharmaceuticals submitted to the FDA? In the past two years, TRACON Pharmaceuticals (TCON) has reported FDA regulatory activity for Uliledlimab (TJ004309). What is the most recent FDA event for TRACON Pharmaceuticals? 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." What conditions do TRACON Pharmaceuticals' current drugs treat? Currently, TRACON Pharmaceuticals has one therapy (Uliledlimab (TJ004309)) targeting the following condition: Advanced cancer. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Entera Bio FDA EventsHumacyte FDA EventsInhibrx Biosciences FDA EventsMedicus Pharma FDA EventsNeurocrine Biosciences FDA EventsPrecigen FDA EventsElanco Animal Health FDA EventsBioCryst Pharmaceuticals FDA EventsCogent Biosciences FDA EventsJazz Pharmaceuticals FDA EventsKymera Therapeutics FDA EventsAbbVie FDA EventsAC Immune FDA EventsAscendis Pharma A/S FDA EventsC4 Therapeutics 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 Related Companies Aditxt FDA Events Dermata Therapeutics FDA Events Fortress Biotech FDA Events Neonc Technologies FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:TCON last updated on 6/20/2025 by MarketBeat.com Staff. 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Provided Update - September 10,2024Provided Update Phase 2Drug: Uliledlimab (TJ004309)Announced Date: September 10, 2024Target Action Date: H1 2025Estimated Target Date Range: January 1, 2025 - June 30, 2025Indication: Advanced cancerAnnouncementI-Mab announced that Randomized Phase 2 study of uliledlimab in combination with pembrolizumab plus chemotherapy expected to begin in 1H 2025AI SummaryI-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
Poster Presentation - September 10,2024Poster Presentation Drug: Uliledlimab (TJ004309)Announced Date: September 10, 2024Indication: Advanced cancerAnnouncementI-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 SummaryI-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
