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TRACON Pharmaceuticals, Inc. (symbol: TCON) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapeutics for the treatment of cancer and wet age-related macular degeneration (AMD). The firm's leading clinical-stage product is Envafolimab (KN035), an investigational PD-L1 single-domain antibody designed for the treatment of soft tissue sarcoma.
The company's portfolio also includes:
- DE-122: Currently in a randomized Phase IIa study targeting wet AMD.
- TRC102: A small molecule in Phase II clinical trials for mesothelioma, Phase I trials for solid tumors, and additional trials for lymphomas and lung cancer.
- TRC253: In Phase II clinical trials for treating metastatic castration-resistant prostate cancer.
- TJ004309: A CD73 antibody in Phase I development for solid tumors.
TRACON Pharmaceuticals operates on a cost-efficient, contract research organization (CRO)-independent product development platform. This unique approach allows the company to partner with ex-U.S. companies, facilitating the development and commercialization of innovative therapies within the United States.
The company's collaborative efforts and licensing agreements with other firms reinforce its commitment to delivering cutting-edge treatments. Financially, TRACON demonstrates resilience and strategic growth, leveraging partnerships to advance their clinical trials and ensure a pipeline of promising therapeutic candidates.
For investors, TRACON Pharmaceuticals represents a significant opportunity in the biopharmaceutical landscape, driven by a robust pipeline of investigational drugs and a strategic focus on effective, targeted cancer therapies.
TRACON Pharmaceuticals (TCON) reported its Q3 2022 financial results, revealing cash and cash equivalents of $17.0 million, down from $24.1 million at year-end 2021, funding expected until mid-2023. The net loss narrowed to $6.4 million from $7.0 million year-over-year. R&D expenses rose to $4.1 million from $2.7 million in Q3 2021. The ongoing ENVASARC Phase 2 trial is ahead of schedule, with an interim efficacy analysis anticipated in Q4 2022. Additionally, binding arbitration with I-Mab is expected to conclude in Q1 2023, potentially recovering over $200 million in damages.
TRACON Pharmaceuticals (Nasdaq: TCON) will announce its Q3 2022 financial results on November 14, 2022, after U.S. markets close. A conference call is scheduled for 4:30 PM ET to discuss these results and corporate activities. The company specializes in developing targeted cancer therapeutics and operates independently of contract research organizations (CROs). The pipeline includes several promising candidates, such as Envafolimab for sarcoma and YH001, a CTLA-4 antibody in Phase 1. TRACON aims to establish partnerships for further development.
TRACON Pharmaceuticals has announced that the Independent Data Monitoring Committee (IDMC) recommended proceeding with the ENVASARC Phase 2 pivotal trial following a safety review of data from over 20 patients. Envafolimab, administered at 600 mg, has been well tolerated both as a monotherapy and in combination with Yervoy. The trial aims to assess efficacy in patients with refractory sarcoma, with interim efficacy data expected in Q4 2022. TRACON also noted continued enrollment exceeding projections, further indicating positive momentum in its clinical pipeline.
TRACON Pharmaceuticals (TCON) has received FDA fast track designation for envafolimab (KN035) targeting unresectable or metastatic undifferentiated pleomorphic sarcoma and myxofibrosarcoma, showing promise in its ENVASARC Phase 2 trial. The fast track status aims to accelerate drug development for serious conditions. TRACON anticipates interim safety and efficacy results from the trial in Q4 2022 and believes envafolimab may offer superior outcomes compared to existing therapies.
TRACON Pharmaceuticals (TCON) announced that CEO Charles Theuer will present at three investor conferences in September 2022. Key events include the Wells Fargo 2022 Healthcare Conference on September 9 at 9:10 AM EDT, and the H.C. Wainwright and RW Baird conferences on September 14 at 3:00 PM and 11:25 AM EDT, respectively. TRACON is focusing on advancing its cancer therapeutics pipeline, which includes Envafolimab and YH001, and is seeking partnerships to enhance its product development capabilities.
TRACON Pharmaceuticals, Inc. (Nasdaq: TCON) has secured a $35 million non-dilutive long-term debt facility with Runway Growth Capital, extending its cash runway into mid-2023. An initial $10 million was drawn to support the pivotal ENVASARC trial and other corporate purposes. This financing also coincides with the expected completion of the Phase 1 TJ4309 trial and an arbitration outcome with I-Mab. The loan has a 24-month interest-only period, followed by principal and interest payments for 24 months.
TRACON Pharmaceuticals (TCON) and Biocytogen have announced FDA approval for a Phase 1/2 clinical trial of YH001 combined with envafolimab and doxorubicin for treating sarcoma patients, including treatment-naive individuals. The trial will evaluate safety and efficacy for various sarcoma subtypes, including alveolar soft part sarcoma and leiomyosarcoma. YH001 is a CTLA-4 targeting antibody, showcasing superior efficacy in preclinical studies compared to ipilimumab. This combination therapy aims to enhance treatment options for sarcoma patients.
TRACON Pharmaceuticals (Nasdaq: TCON) announced FDA approval for its IND application to start a Phase 1/2 clinical trial for YH001, envafolimab, and doxorubicin in treating sarcoma patients. The trial aims to evaluate safety and efficacy in rare sarcoma subtypes and assess a triplet combination for more prevalent types. YH001, a novel CTLA-4 antibody, displayed promising preclinical results compared to ipilimumab. TRACON is eager to commence patient enrollment for this trial, enhancing treatment options for sarcoma patients.
TRACON Pharmaceuticals (TCON) reported its second quarter financial results for 2022, revealing cash reserves of $13.6 million, down from $24.1 million at year-end 2021. The net loss narrowed to $6.2 million from $8.9 million year-over-year. The company is advancing its ENVASARC pivotal trial, having enrolled 36 patients, with interim efficacy results expected in Q4 2022. Additionally, TRACON has engaged in arbitration over potential damages exceeding $200 million related to agreements with I-Mab, with outcomes anticipated this year.
TRACON Pharmaceuticals (Nasdaq: TCON) announced that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended proceeding with the study, following safety reviews of over 20 patients. The trial evaluates envafolimab, a PD-L1 inhibitor, in refractory sarcoma patients. Initial safety data indicated a good tolerance for envafolimab, both alone and in combination with Yervoy (ipilimumab). The company is on track for an interim efficacy data review in the fourth quarter of 2022.
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