BioCardia Phase III pivotal CardiAMP trial unlikely to meet endpoint

6 September 2023

Adding to an earlier setback, cellular and cell-derived drug developer BioCardia (Nasdaq: BCDA), yesterday announced it has finalized external review of interim data and evaluated interim efficacy results for the ongoing Phase III pivotal trial of CardiAMP Cell Therapy for Heart Failure (CardiAMP HF) which disappointed.

The news saw BioCardia’s shares closed done 25.5% at $0.58.

A Data Safety Monitoring Board (DSMB) had already recommended that BioCardia pause the trial pending the one-year follow-up outcomes analysis for patients that have been treated and those that have been enrolled but not yet treated.

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