BioCardia announces consultation success with PMDA for BCDA-01 registration, targeting ischemic heart failure treatment. Data expected Q1 2025.
Quiver AI Summary
BioCardia, Inc., a leader in cell-derived therapeutics for cardiovascular diseases, announced the successful completion of a consultation with Japan's PMDA regarding the registration of its key therapeutic asset, BCDA-01, aimed at treating ischemic heart failure of reduced ejection fraction (HFrEF). During the meeting, PMDA confirmed that it would accept the final clinical data submission with two-year follow-up to assess the safety and efficacy evidence for BCDA-01. The agency is also considering results from the ongoing CardiAMP Heart Failure Trial as sufficient for the registration of the CardiAMP Cell Therapy System in Japan. BioCardia is finalizing data from the trial, which included 125 patients, and expects to release results in early 2025. The therapy has received Breakthrough Designation from the FDA, and its trials are supported by CMS reimbursement.
Potential Positives
- Successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA), indicating progress toward regulatory approval.
- Invitation for a subsequent consultation from PMDA to review the sufficiency of evidence for claims of safety and efficacy, demonstrating regulatory engagement and support.
- Anticipation of final data from the fully enrolled 125 patient CardiAMP Heart Failure Trial in the first quarter of 2025, signaling advancement in clinical development.
- Breakthrough Designation from the FDA for BCDA-01, highlighting the potential significance of the therapy in treating ischemic heart failure.
Potential Negatives
- The press release indicates ongoing reliance on future clinical trial results to substantiate claims for BCDA-01, which introduces uncertainty regarding the product's acceptance and potential regulatory hurdles in Japan.
- BioCardia has yet to secure a definitive pathway for the registration of BCDA-01, as future consultations will depend on forthcoming clinical data, indicating a lack of certainty in progress.
- The acknowledgment of risks inherent in the forward-looking statements serves as a reminder of potential setbacks that could affect the company's market performance and investor confidence.
FAQ
What is the purpose of BioCardia's BCDA-01 therapy?
BCDA-01 is designed for the treatment of ischemic heart failure with reduced ejection fraction (HFrEF).
What recent consultation did BioCardia complete?
BioCardia completed a consultation with Japan's PMDA regarding the registration submission for BCDA-01.
What outcomes were expected from the PMDA meeting?
PMDA invited a follow-up consultation to review clinical data supporting safety and efficacy claims for BCDA-01.
When will final data from the CardiAMP Heart Failure Trial be available?
Final data from the trial is anticipated to be available in the first quarter of 2025.
What recognition has the CardiAMP Cell Therapy received from the FDA?
CardiAMP Cell Therapy received Breakthrough Designation from the FDA's Center for Biological Evaluation and Research.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
SUNNYVALE, Calif., Dec. 04, 2024 (GLOBE NEWSWIRE) --
BioCardia, Inc.
[Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today the successful completion of a consultation with Japan's Pharmaceutical and Medical Device Agency (PMDA) on the next steps for the submission for registration of its lead therapeutic asset, BCDA-01, for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF).
"This most recent meeting with PMDA had several important outcomes," said Peter Altman, Ph.D., BioCardia's President and Chief Executive Officer." First, PMDA has invited our next consultation after the submission of our final clinical data with two-year follow-up to review the sufficiency of evidence to support claims of safety and efficacy for the BCDA-01 program. Second, PMDA remains open to the results from the CardiAMP Heart Failure Trial and our previous trials being sufficient evidence for registering CardiAMP Cell Therapy System for patients with heart failure in Japan."
Dr. Altman continued, "We are working on data lock from our fully enrolled 125 patient CardiAMP Heart Failure Trial and anticipate final data will be available in the first quarter of 2025."
CardiAMP Cell Therapy for the treatment of HFrEF (BCDA-01) has received Breakthrough Designation from Food and Drug Administration Center for Biological Evaluation and Research (FDA CBER), with development supported by the Maryland Stem Cell Research Fund. All CardiAMP Cell Therapy clinical trials in the United States (BCDA-01 and BCDA-02) are also supported by reimbursement from the Center for Medicaid and Medicare Services (CMS).
About BioCardia:
BioCardia, Inc.
, headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP
autologous and CardiALLO allogeneic cell therapies are the Company's biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph
vascular navigation product platforms. For more information visit:
.
Forward Looking Statements:
This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company's investigational product candidates, the timing of data lock on the CardiAMP Heart Failure Trial, the timing of availability of data from this trial, and future consultations with Japan PMDA. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.
We may use terms such as "believes," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should," "approximately" or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia's Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled "Risk Factors" and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.
Media Contact:
Miranda Peto, Investor Relations
Email:
mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email:
investors@BioCardia.com
Phone: 650-226-0120
