BioCardia anticipates Japan PMDA review and FDA meeting request on CardiAMP in Q4 2025 while advancing clinical programs [Seeking Alpha]
BioCardia, Inc. (BCDA)
US:NASDAQ Investor Relations:
biocardia.com/investors/press-releases/id/1037?pressreleaseid=41
Company Research
Source: Seeking Alpha
CEO Peter Altman provided updates on regulatory progress for CardiAMP cell therapy targeting ischemic heart failure, noting, "we have been working on regulatory submissions on the strength of our clinical data for Quick Insights BioCardia anticipates a PMDA clinical review in Japan and an FDA meeting request on approvability for CardiAMP in Q4, with ongoing CardiAMP Heart Failure II trial enrollment. BioCardia ended the quarter with $5.3 million in cash after recent financing, saw R&D expenses increase slightly, and net loss decrease, indicating a stable financial runway to support planned initiatives. Key challenges include resource allocation and operational bandwidth for accelerating trial enrollment and submissions, dependence on regulatory outcomes in Japan and the U.S., and the need for nondilutive funding, especially for BCDA-03. Recommended For You More Trending News
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BCDA
News
- BioCardia Cell Therapy for Ischemic Heart Failure to Progress to Formal Clinical Consultation with Japan PMDAGlobeNewswire
- BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard Krasno [Yahoo! Finance]Yahoo! Finance
- BioCardia Announces Election of New Board Director, Marvin Slosman and Completion of Term for Outgoing Director, Dr. Richard KrasnoGlobeNewswire
- BioCardia to Present at December 2025 CSI Focus Devices in Heart Failure CongressGlobeNewswire
- BioCardia Strengthens Leadership Team with The Addition of Farhan Shahab as Vice President of QualityGlobeNewswire
BCDA
Sec Filings
- 1/21/26 - Form 4
- 12/18/25 - Form S-8
- 12/17/25 - Form 4
- BCDA's page on the SEC website