FDA Approves BioCardia® Investigational New Drug Application

Apr 12, 2022 By MarketDepth

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FDA Approval

BioCardia®, Inc. (Nasdaq: BCDA) today announced that the U.S. Food and Drug Administration (FDA) approved its Investigational New Drug (IND) application for BCDA-04.

Up Over 26%

Shares of BioCardia®, Inc. (Nasdaq: BCDA) gained over 26% during the premarket trading session following the announcement.

“This investigational cell therapy is administered intravenously (IV) and follows a significant body of compelling clinical results by NIH investigators and peer companies.”

Ian McNiece, Ph.D., BioCardia’s Chief Scientific Officer

BCDA-04 is a proprietary allogeneic mesenchymal cell (MSC) population that is Neurokinin-1 receptor positive (NK1R+), and the newly approved IND allows BioCardia to initiate its First-in-Human Phase I/II trial in adult patients recovering from Acute Respiratory Distress Syndrome (ARDS) due to COVID-19, with trial initiation expected in the third quarter of 2022.

“In addition to our critically important autologous cell therapies being studied for ischemic heart failure and chronic myocardial ischemia with refractory angina, the FDA’s acceptance of this IND for patients recovering from ARDS is an important milestone in the development of our allogeneic mesenchymal stem cell therapy platform and validation for its potential to provide therapeutic benefit beyond the cardiovascular system.”

Peter Altman, Ph.D., Chief Executive Officer