BioCardia Shares Double After FDA Approves CardiAMP Trial

By Dean Seal

Shares of BioCardia more than doubled after the company said regulators have approved a Phase 3 trial of its CardiAMP treatment for patients with ischemic heart failure.

Shares surged to 96 cents in premarket trading after closing at 40 cents Monday, down 81% year-to-date at that time.

The Sunnyvale, Calif.-based company said the U.S. Food and Drug Administration has approved its proposed CardiAMP Heart Failure II study protocol.

"CardiAMP Heart Failure II has strong support from our clinical investigators who have reviewed the interim trial results in detail and have first-hand knowledge of this great unmet clinical need," Chief Executive Peter Altman said.

The first CardiAMP Heart Failure trial, which is currently ongoing, has already completed enrollment and should have final data analysis reportable by the fourth quarter of 2024.

Write to Dean Seal at [e-mail]

(END) Dow Jones Newswires

11-14-23 0751ET