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BioCardia Inc. - BCDA STOCK NEWS

Welcome to our dedicated news page for BioCardia (Ticker: BCDA), a resource for investors and traders seeking the latest updates and insights on BioCardia.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect BioCardia's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of BioCardia's position in the market.

News
BioCardia Shares Update from Japan PMDA Consultation on CardiAMP Autologous Cell Therapy for Ischemic Heart Failure; Foreign Data Expected to be Sufficient for Product Approval
Rhea-AI Summary
BioCardia, Inc. (Nasdaq: BCDA) provided an update after its recent consultation with Japan’s Pharmaceutical and Medical Device Agency (PMDA) towards approval of its CardiAMP autologous cell therapy for the treatment of patients with ischemic heart failure of reduced ejection fraction (HFrEF). PMDA requested further details on elements included in BioCardia’s CardiAMP preclinical and clinical packages. BioCardia management believes these can be readily addressed. PMDA indicated they would like to see detailed interim and the final results from the CardiAMP Heart Failure Trial, which has completed patient enrollment and is finishing up study patient follow-up visits. Formal minutes from the PMDA meeting are expected in four weeks and a follow-up consultation is being planned.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.45%
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none
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News
BioCardia Announces $1.3 Million Registered Direct Offering of Common Stock Priced At-the-Market under Nasdaq Rules
Rhea-AI Summary
BioCardia, Inc. [Nasdaq: BCDA] Announces Registered Direct Offering of Common Stock
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-15.79%
Tags
offering
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News
BioCardia Announces FDA Approval of CardiAMP Heart Failure II Protocol for Autologous Cell Therapy for Ischemic Heart Failure
Rhea-AI Summary
BioCardia, Inc. (Nasdaq: BCDA) announces FDA approval of Phase III clinical trial for CardiAMP autologous cell therapy in the treatment of ischemic heart failure. Interim analysis shows significant clinical improvements over controls, including a 59% relative risk reduction in heart death and a 54% relative risk reduction of Major Adverse Cardiovascular or Cerebrovascular events (MACCE). FDA approves proposed CardiAMP Heart Failure II study protocol with modified primary efficacy endpoint and eligibility requirements.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
167.5%
Tags
fda approval
News
BioCardia Reports Third Quarter 2023 Business Highlights and Financial Results
Rhea-AI Summary
BioCardia, Inc. [Nasdaq: BCDA] reports Q3 2023 financial results and operational updates, including progress in CardiAMP Cell Therapy program for heart failure and chronic myocardial ischemia. The company also highlights strategic efforts to secure partnerships and grants for clinical development.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-6.82%
Tags
earnings
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News
BioCardia to Host Q3 2023 Corporate Update and Financial Results Conference Call on November 8, 2023
Rhea-AI Summary
BioCardia, Inc. will provide a corporate update and report its financial results for Q3 and 9 months ended September 30, 2023. The conference call will take place on November 8, 2023, at 4:30 PM ET. Participants can register for the conference call through the provided link. The call will also be available through a live webcast, with a replay available afterwards.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-- %
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conferences earnings
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News
BioCardia Announces Completion of Enrollment in Phase III CardiAMP HF Trial and Plans for CardiAMP HF Trial II
Rhea-AI Summary
BioCardia completes enrollment in CardiAMP Heart Failure Trial and initiates discussion with FDA for second pivotal study
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
28.21%
Tags
clinical trial
News
BioCardia Announces Clarification and Next Steps on its Autologous CardiAMP Cell Therapy Programs
Rhea-AI Summary
BioCardia announces clarification and next steps on its autologous CardiAMP cell therapy programs. Interim results show potential for a successful trial for product registration in the United States. FDA prefers replacing 6MWD with Cardiopulmonary Exercise Testing. BCDA-02 shows great potential for success. BioCardia expects to focus on accelerating pivotal program. Anticipated upcoming milestones and events provided.
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-12.07%
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none
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News
BioCardia Announces Interim Efficacy Results in Phase III Pivotal CardiAMP Cell Therapy Heart Failure Trial
Rhea-AI Summary
BioCardia announces interim data review for Phase III trial of CardiAMP Cell Therapy for Heart Failure
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-25.64%
Tags
clinical trial
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News
BioCardia Reports Second Quarter 2023 Business Highlights and Financial Results
Rhea-AI Summary
BioCardia reports financial results for Q2 2023 and provides updates on clinical trials. Enrollment in autologous cell therapy trial for ischemic heart failure paused based on DSMB recommendation. Other clinical programs reaching important milestones. Business development active around Helix biotherapeutic delivery platform.
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earnings
News
BioCardia to Host Q2 2023 Financial Results and Corporate Update Conference Call on August 9, 2023
Rhea-AI Summary
Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
2.06%
Tags
conferences earnings
Stock BCDA logo
BioCardia Inc.

Nasdaq:BCDA

BCDA Rankings

#5369 Ranked by Market Cap
N/A Ranked by Stock Gains
N/A Ranked by Dividends

BCDA Stock Data

9.79M
17.59M
33.84%
7.71%
2%
Surgical and Medical Instrument Manufacturing
Manufacturing
Link
US
San Carlos

About BCDA

we are a clinical-stage regenerative medicine company developing novel therapeutics for cardiovascular diseases with large unmet medical needs. biocardia is developing proprietary comprehensive biotherapeutic solutions for cardiovascular disease in its cardiamp™ and cardiallo™ therapies. clinical results supporting both therapeutic programs are compelling and build upon the most rigorous data in the field to date with intramyocardial delivery of marrow-derived cells. these programs are enabled by the company's helix™ transendocardial delivery systems and morph® vascular access products, which are partnered to enable other promising biotherapeutic programs.