Why Are Check-Cap Shares Plummeting Today?

Following an internal assessment of the clinical data collected from calibration studies, Check-Cap Ltd CHEK said the current efficacy results do not meet the goal to proceed to the powered portion of the U.S. pivotal study.
The company initiated the first part of the pivotal U.S. study of C-Scan in May 2022, focusing on device calibration and enhancement of C-Scan algorithms among the average-risk U.S. population.
Check-Cap said the calibration studies’ target is to optimize the C-Scan device for the average risk population before commencing the powered portion of the U.S. pivotal study, which aims to demonstrate C-Scan performance in a statistically significant manner.
The initiation of the powered portion of the U.S. pivotal study was dependent upon the successful completion of the calibration portion of the U.S. pivotal study.
The initiation of the powered portion of the U.S. pivotal study that was expected in mid-2023 is therefore temporarily postponed.
The company will conduct additional clinical data analysis and approach the FDA to make amendments to the U.S. pivotal study protocol that are expected to be part of an IDE supplement submission to the FDA.
The company plans to continue conducting its calibration studies, albeit slower, to collect additional clinical data. It is also implementing a cost reduction plan to extend its cash runway.
Price Action: CHEK shares are down 44.10% at $1.69 on the last check Tuesday.