Shares of BioCardia dropped 46% to a new 52-week low of $1.06 following the announcement that the ongoing Phase 3 pivotal CardiAMP Cell Therapy Heart Failure trial will be paused. The company is awaiting the one-year follow-up outcomes analysis for both treated and enrolled-but-not-yet-treated patients.
The stock had already closed Friday's session down 14% and has seen a 32% decline over the past year.
According to BioCardia, an independent Data Safety Monitoring Board responsible for reviewing the trial has completed its data review as initially planned, and it has recommended the pause in order to collect additional blind data.
It is important to note that the recommendation to pause the trial is unrelated to any safety concerns. Additionally, the DSMB has recommended that no new patient enrollments or potential crossover procedures take place until an outcomes analysis is conducted on patients who have completed their one-year follow-up or are currently undergoing treatment.
Furthermore, enrolled patients who are about to complete their treatment sequence will be informed about the trial pause in order to evaluate intermediate study results.
The recent interim review of the trial was based on data from 132 procedures involving 111 randomized patients, including both treated individuals and those in the control group.
The blinded data report, which encompasses all patients (treated and control), indicates that the survival rate at follow-up is higher than that observed in recent large pivotal trials involving patients with heart failure and reduced ejection fraction.