BCDA - BioCardia stock soars 59% after FDA nod to begin trial of BCDA-04 in COVID patients

The U.S. Food and Drug Administration (FDA) approved BioCardia's (NASDAQ:BCDA) application seeking to start a  phase 1/2 trial of BCDA-04 in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19. The company said the approval of its investigational new drug (IND) application will allow it to start its first-in-human phase 1/2 trial in adult patients recovering from ARDS due to COVID-19, with trial initiation expected in Q3. The company said BCDA-04 is a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+). The first part of the study will evaluate increasing doses of the NK1R+ MSCs and the optimal dose will be taken to phase 2. "We expect the anti-inflammatory nature of these mesenchymal stem cells to have a positive impact in ARDS because of the interaction of the Neurokinin-1 receptors with Substance P, a neuropeptide that has long been known to be a primary mediator of inflammation

For further details see:

BioCardia stock soars 59% after FDA nod to begin trial of BCDA-04 in COVID patients