Check-Cap Ltd. (NASDAQ: CHEK) revealed that it has bagged the U.S. Food and Drug Administration’s approval for its amended Investigational Device Exemption (IDE) application, enabling initiation of the U.S. pivotal study.
The clinical-stage medical diagnostics company engages in developing gastrointestinal imaging devices. CHEK’s shares rose 11.7% on Monday and a further 3% in the extended trading session.
The company said that its U.S. pivotal study consists of two parts. In the first part, Check-Cap will enable further calibration of the system for the average risk U.S. population. The other part includes a statistically powered, randomized study that will compare the performance of C-Scan to traditional colonoscopy.
The CEO of Check-Cap, Alex Ovadia, said, “Now that we have received approval from the FDA of our amended protocol, we are focused on final preparations to initiate the first part of the U.S. pivotal study, which we anticipate will begin in March-April 2022, followed by initiation of the second part of the study in Q4 2022.”
“Initiation of the study signifies a major step in the clinical development of our device, which is designed to detect precancerous polyps,” he added.
Check-Cap’s Earnings
The company is expected to report a loss of $0.03 per share for the fourth quarter of 2021. Check-Cap stock earnings history has been volatile over the past few quarters. It is expected to report earnings on March 17, 2022.
Overall, the analysts are cautiously optimistic about the stock with a Moderate Buy consensus rating based on 2 Buys.
Negative Sentiment
TipRanks’ Stock Investors tool shows that investors currently have a Very Negative stance on Check-Cap, as 3.9% of investors on TipRanks decreased their exposure to CHEK stock over the past 30 days.
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