New York, June 5, 2026, 11:11 (EDT)
- BioCardia jumped around 52% to $1.40 on Nasdaq near midday, after touching $1.78 earlier.
- The company said FDA meeting minutes confirmed its ongoing CardiAMP HF II trial could support a PMA, the U.S. approval route for high-risk devices.
- The rally happened as biotech slipped, with both XBI and IBB down.
BioCardia Inc. shares surged over 50% in busy trading Friday. The move followed an announcement that the company received FDA meeting minutes that could allow its ongoing CardiAMP HF II trial to back a marketing application for its heart-failure cell therapy.
The stock traded at $1.40, up 48 cents, with volume above 117 million shares. It earlier hit an intraday high of $1.78. The gain came as the SPDR S&P Biotech ETF dropped about 1.2%, and the iShares Nasdaq Biotechnology ETF also fell.
BioCardia is in focus as it tries to shift from a small clinical-stage firm burning cash into a regulatory play. The company is aiming for Premarket Approval, or PMA, with the FDA, the main process for high-risk medical devices to prove safety and effectiveness before hitting the market.
BioCardia said in an 8-K that it got minutes back from a Q-Sub meeting with the FDA’s Center for Biologics Evaluation and Research. The company said those minutes confirm the CardiAMP Heart Failure II Trial can be used to support a PMA for market clearance in ischemic heart failure with reduced ejection fraction, where the heart muscle is too weak to pump enough blood.
BioCardia said the FDA has said it usually wants two strong trials for big conditions like HFrEF. The company pointed to a possible U.S. patient base of over 1 million who might use the therapy if it gets approval.
BioCardia CEO Peter Altman said the “microvascular repair” approach might align with existing guideline-directed therapy. He said BioCardia is moving to finish the U.S. trial and plans to “submit for regulatory approval in Japan.” SEC
Japan is moving in step with the rest of the trade. BioCardia last week said its PMDA consultation record in Japan backed a regulatory filing for CardiAMP in ischemic HFrEF, and the company expects to submit in the fourth quarter. Altman said at the time the clinical data looked “sufficient to support approval,” but BioCardia added PMDA had requested post-marketing study plans and more details on which patients would be selected. SEC
Few cell-therapy stocks moved with BioCardia. Mesoblast dropped roughly 3.3%, and Capricor Therapeutics lost about 1.1%. Both develop different cellular medicines.
Stocks fell in early trade. Wall Street’s big indexes were down as U.S. jobs data came in strong, raising bets on tighter Fed policy. The Nasdaq dropped 1.39% by 09:43 a.m. ET, Reuters said.
FDA feedback isn’t the same as approval. BioCardia still has to run its trial, put together a full PMA, and find more funding. The most recent quarterly filing showed $951,000 in cash as of March 31. BioCardia said that won’t last for the planned spending past June 2026 unless it raises more money. The company also said there’s substantial doubt it can keep operating as a going concern.
Listing is another concern. BioCardia said in its quarterly filing it isn’t meeting Nasdaq’s $2.5 million minimum stockholders’ equity rule. The company got a notice on April 10, but the notice hasn’t affected trading in its shares under BCDA.
Regulatory clarity is in focus for traders. BioCardia’s market cap sat near $15 million after Friday’s jump. The stock is still moving on trial news, financing and fresh signals from FDA or Japan’s PMDA.
