Tracon Pharmaceu Stock Price, News & Analysis

TRACON Pharmaceuticals (NASDAQ: TCON) has appointed Ya Huang as the new Executive Director of Statistical Programming, enhancing its statistical data team in preparation for the anticipated BLA filing for envafolimab in treating sarcoma. Huang brings over 20 years of experience from companies like Arena Pharmaceuticals and Gilead. Concurrently, he received an inducement equity award of 37,000 shares with an exercise price of $6.94, vesting over four years. Envafolimab is currently in multiple pivotal trials, including the ENVASARC trial in the U.S.

On June 29, 2021, TRACON Pharmaceuticals (TCON) announced that the FDA granted Orphan Drug Designation to envafolimab for treating soft tissue sarcoma. The designation follows the submission of Phase 1 clinical trial data, revealing a 40% response rate in patients with refractory metastatic alveolar soft part sarcoma. Orphan Drug status provides benefits like tax credits and seven years of marketing exclusivity. Envafolimab is currently under evaluation in pivotal trials in the U.S. and China, targeting various cancer types.

TRACON Pharmaceuticals (NASDAQ:TCON) announced updated data from its Phase 1 study of TJ004309 in combination with Tecentriq (atezolizumab) at the recent ASCO virtual annual meeting. The study involved 20 patients with advanced cancers, revealing that uliledlimab was well-tolerated without dose-limiting toxicities. Notably, clinical activity was observed, including one complete response and two partial responses. The results indicate a need for further investigation of uliledlimab with checkpoint inhibitors in lung and ovarian cancers.

TRACON Pharmaceuticals (NASDAQ: TCON) announced that the Independent Data Monitoring Committee has recommended the continuation of the ENVASARC pivotal trial after reviewing safety data from over 20 patients. The trial, which evaluates the efficacy of Envafolimab in patients with refractory sarcoma, is proceeding as planned. The company anticipates further safety and interim efficacy data reviews in upcoming quarters. Envafolimab is notable for being the first subcutaneously injected PD-(L)1 inhibitor studied in pivotal trials, further reinforcing TRACON's commitment to developing targeted cancer therapies.

TRACON Pharmaceuticals (NASDAQ: TCON), a clinical-stage biopharmaceutical firm, will present a corporate overview at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 2:30 PM ET. Charles Theuer, M.D., Ph.D., President and CEO, will lead the presentation. Attendees can access the live webcast on TRACON's website. The company focuses on developing targeted cancer therapies and leverages a cost-efficient, CRO-independent platform to partner with international firms for U.S. product commercialization. Key candidates include Envafolimab and TRC102.

TRACON Pharmaceuticals (NASDAQ: TCON) announced two abstracts for the American Society of Clinical Oncology (ASCO) 2021 annual meeting from June 4-8, 2021. The first abstract covers the ENVASARC pivotal trial of Envafolimab, targeting advanced or metastatic undifferentiated pleomorphic sarcoma or myxofibrosarcoma. The second discusses the preliminary data of TJ004309, a CD73 antibody combined with atezolizumab in advanced cancer. Envafolimab shows promising response rates in prior trials, being compared favorably against established therapies.

TRACON Pharmaceuticals (NASDAQ:TCON) announced its financial results for Q1 2021, reporting a net loss of $5.1 million, up from $4.0 million in Q1 2020. Cash and short-term investments decreased to $30.4 million from $36.1 million in Q4 2020, expected to fund operations into late 2022. The company is making progress with its ENVASARC trial, having initiated 22 U.S. sites and enrolled over 20 patients, triggering a Data Monitoring Committee review. The resubmission of the Orphan Drug Designation for envafolimab is anticipated to receive FDA feedback this quarter.

TRACON Pharmaceuticals (NASDAQ: TCON) announced the appointment of Dongliang Zhuang, Ph.D., as Vice President of Statistics and Biometrics. Dr. Zhuang brings over 20 years of experience, including significant roles at the U.S. FDA and in major biopharmaceutical companies. His expertise is expected to enhance TRACON's efforts to complete the ENVASARC trial and seek a Biologics License Application (BLA) for envafolimab. Envafolimab is a PD-L1 inhibitor currently in pivotal trials, showing promising objective response rates in various cancer treatments.

TRACON Pharmaceuticals (NASDAQ:TCON) will report its Q1 2021 financial and operational results on May 5, 2021, after market close. A conference call is scheduled for the same day at 4:30 PM ET to discuss the results and provide updates on corporate activities. The company develops targeted cancer therapies and is focused on securing partnerships to lead U.S. regulatory, clinical development, and commercialization for its innovative product pipeline. Key assets include Envafolimab and TRC253.