BioCardia, Inc. (BCDA) shares soared 48.13 percent, gaining $0.4423 to $1.3613 on Friday after the company announced that it received meeting minutes from the U.S. Food and Drug Administration confirming that its ongoing CardiAMP Heart Failure II Trial may support a Premarket Approval application for the CardiAMP Cell Therapy System in patients with ischemic heart failure with reduced ejection fraction (HFrEF).
The stock is currently trading at $1.3613, compared with its previous close of $0.9190 on the Nasdaq. During the session, it opened at $1.1950 and traded between $1.0800 and $1.8000. Trading volume surged to 126.24 million shares, dramatically exceeding its average volume of 164,233 shares.
The FDA feedback represents a significant regulatory milestone, as PMA is the agency's most rigorous approval pathway for high-risk medical devices. The company noted that the completed CardiAMP HF clinical data could serve as the first of two trials supporting a future PMA submission.
BioCardia shares have traded between $0.8400 and $2.4500 over the past 52 weeks.
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