What's Going On With TRACON Pharmaceuticals Shares Today

TRACON Pharmaceuticals TCON shares are trading lower Thursday morning after the company released the results of a six-month independent data monitoring committee (IDMC) review for the ongoing ENVASARC Phase 2 trial.

The IDMC reviewed interim safety and efficacy data from more than 80 patients equally randomized into cohort C of single-agent envafolimab or cohort D of envafolimab given in combination with Bristol‑Myers Squibb's BMY Yervoy (Ipilimumab). 

Envafolimab was well tolerated without a single > grade 2 drug-related adverse event. 

The combination of envafolimab with Yervoy did not demonstrate synergy compared to single agent envafolimab, and the company will terminate enrollment in cohort D. 

This is expected to result in reduced trial costs and acceleration of the timeline to final ENVASARC data.

"We are pleased with the single agent activity of envafolimab that continues to generate a double-digit ORR, as well as the safety data showing envafolimab is well tolerated," said James Freddo, TRACON's Chief Medical Officer. 

"We believe the current response rate indicates that we remain on track to achieve the study's primary endpoint of a minimum 11.25% objective response rate."

A planned interim analysis in the third quarter will be conducted after the 46th patient treated with envafolimab has completed a minimum of 12 weeks of efficacy evaluations and includes a futility rule currently being exceeded based on available data.

Tracon stock has a session volume of 783K shares traded, compared to the trailing 100-day volume of 194.7K shares.

According to data from Benzinga Pro, TCON has a 52-week high of $2.31 and a 52-week low of $0.49.

Price Action: TCON shares are down 14.50% at $0.42 on the last check Tuesday.