200% Gain In One Day - Why Is Heart Failure Focused BioCardia Stock Soaring Today?

The FDA approved BioCardia Inc's BCDA Phase 3 CardiAMP Heart Failure II study protocol of CardiAMP autologous cell therapy for ischemic heart failure.

The currently ongoing CardiAMP Heart Failure trial has completed enrollment, and the final data analyses are anticipated to be reported in Q4 2024. 

In an interim analysis of available data to date for study patients followed up through two years, those having N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels consistent as demarcating heart failure (>500 pg/ml) at screening baseline showed meaningful clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events (MACCE). 

The FDA has approved the proposed CardiAMP Heart Failure II study, which includes an eligibility requirement that patients demonstrate a pre-specified NT-proBNP level at baseline. 

The proposed primary efficacy endpoint is also modified from that in the currently ongoing study. The CardiAMP Heart Failure II endpoint is a similar hierarchical composite assessment but consists of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device (LVAD) implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient, and change in quality-of-life, with a follow-up duration ranging from a minimum of 12 to a maximum of 24 months. 

Price Action: BCDA shares are up 225.70% at $1.30 on the last check Tuesday.