Summary
• BioCardia’s stock (BCDA) dropped 8.6% in pre-market trading to $1.17, reflecting a bearish trend.
• The company completed a third consultation with Japan’s PMDA regarding its CardiAMP Cell Therapy for heart failure, with potential regulatory implications.
• Despite a positive analyst buy rating, significant volatility persists, with the stock down 60% over the last year.
BioCardia, Inc. (BCDA) is trading at $1.17 in pre-market trading, reflecting an 8.6% decline from its last close of $1.28. The stock is exhibiting a bearish trend without a clear catalyst for the movement this morning.
Regulatory Consultations Progress Reported
On December 16, 2025, BioCardia announced that it completed a third preliminary clinical consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) regarding its CardiAMP Cell Therapy, aimed at treating heart failure with reduced ejection fraction (HFrEF). This meeting was integral as it paves the way for a formal clinical consultation where the acceptability of existing clinical data will be evaluated for a potential regulatory approval application. The PMDA’s indication to allow progress to formal consultation could be significant, should subsequent discussions affirm the safety and efficacy of the therapy.
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Market and Technical Picture
BioCardia is currently witnessing significant volatility, with a 52-week performance of -60%, and year-to-date performance down 41.3%. The stock has a relative strength index (RSI) of 40.8, suggesting it may be nearing oversold conditions. Its average trading volume shows a stark contrast, with the 10-day average at 61,532 shares compared to the 3-month average of 569,393 shares, indicating lighter trading in the recent period. The stock’s movement this morning continues a broader downward trend, reflecting concerns that could be weighing on investor sentiment.
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Recent Filings and Analyst Ratings
BioCardia also filed an 8-K on December 16 to accompany its latest press release about the PMDA discussions. While analyst sentiment remains relatively positive with a buy rating, investor focus is likely to shift toward the implications of the regulatory consultations and how they could affect the company’s future trajectory.
With no fresh catalyst in play, the move reflects routine market activity as participants evaluate short-term positioning.