2023-09-05 10:36:53 ET
Shares of BioCardia ( NASDAQ: BCDA ) tumbled 22% in early trading Tuesday after the biotech company said it doesn’t expect a Phase III pivotal study for its CardiAMP cell therapy to meet its primary endpoint in the treatment of heart failure.
BioCardia said that a review of interim efficacy results indicated the trial will not achieve its endpoint at 12 months. While the data did indicate some patient benefits from the therapy, such as reduction in all cause death, it was not statistically significant.
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BioCardia doesn't see Phase 3 study meeting primary endpoint, stock slides