Shares of biopharmaceutical company Inventiva experienced a significant drop in premarket trading in New York following the announcement that the screening and randomization of patients in a trial has been temporarily halted. The decision came after an adverse event occurred in one patient.
American depositary receipts (ADRs) tied to Inventiva's shares fell by over 20%, reaching $3.15 in premarket trading. This decline compounds the already disappointing performance of the ADRs, which had already dropped by more than 34% in the past year.
In a statement released late on Thursday, Inventiva revealed that a patient participating in its NATiV3 clinical trial had experienced adverse liver test results. The event was categorized as a "Suspected Unexpected Serious Adverse Reaction." Consequently, the study drug was immediately discontinued for this particular patient.
The adverse event was reported to regulators, and the trial's data-monitoring committee (DMC) granted permission to continue the trial with additional precautions. In response, the company has voluntarily paused the screening and randomization process in order to implement these recommendations. However, patients who are currently enrolled in the trial will continue to receive treatment based on the newly prescribed guidelines from the DMC.
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