TCON - Tracon Pharma drops 9% despite 'positive' envafolimab results from ENVASARC trial

TRACON Pharmaceuticals (NASDAQ:TCON) announces that the Independent Data Monitoring Committee (IDMC) for the ongoing ENVASARC pivotal trial recommended continued accrual as planned in both cohort A of single agent envafolimab and cohort B of envafolimab given with Yervoy (ipilimumab). Shares down 9.5% premarket at $3.30. The IDMC reviewed interim safety and efficacy data from 18 patients enrolled into each cohort who completed a minimum of 12 weeks of efficacy evaluations. The objective response rate (ORR) by Blinded Independent Central Review (BICR) in each cohort satisfied the prespecified futility rule. Envafolimab was well tolerated, with only a single Grade 3 related adverse event reported in 36 patients. Based on the highly tolerable safety profile and the significantly higher ORR observed in lower weight patients, the IDMC recommended increasing the envafolimab dose to 600 mg Q3W, which is twice the current envafolimab dose of 300 mg Q3W. TRACON expects to enroll 160 patients with

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Tracon Pharma drops 9% despite 'positive' envafolimab results from ENVASARC trial