BioCardia (BCDA) Dips 26% on Flunking Heart Failure Study
Shares of BioCardia BCDA plummeted 25.5% on Tuesday after management announced disappointing interim results from an ongoing pivotal phase III study evaluating the company’s CardiAMP cell therapy for heart failure.
Based on a one-year follow-up review, the results from the interim analysis indicate that the study is unlikely to meet its primary efficacy endpoint based on the three-tiered Finkelstein-Schoenfeld (FS) hierarchical analysis of 12-month data.
Per BioCardia, patients treated with CardiAMP cell therapy did not show any statistically significant improvement over those in the control group in any of the three tiers – all-cause death (including cardiac death equivalents), non-fatal major adverse cardiac events (MACCE) and change in six-minute walk test distance (6MWT).
However, the study investigators stated that the patients treated with CardiAMP cell therapy reported lower rates of adverse outcomes than those in the control group.
Currently, management is identifying patients from the study who have responded the most to CardiAMP cell therapy. It plans to use the findings from this study in BioCardia’s other ongoing clinical programs.
In the year so far, shares of BioCardia have plunged 72.3% compared to the industry’s 13.2% fall.
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The above announcement also confirms the recommendation issued in July from an independent data safety monitoring board (DSMB) for pausing enrolment in the study until a one-year follow-up analysis was available. This recommendation was based on an initial analysis of data by the DSMB, wherein it concluded that the study was not likely to meet its primary efficacy endpoint.
CardiAMP cell therapy uses a patient's bone marrow cells to the heart via a catheter-based procedure to stimulate the body’s natural healing response.
BioCardia, Inc. Price
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Zacks Rank & Stocks to Consider
BioCardia currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Annovis Bio ANVS, Dynavax Technologies DVAX and Gracell Biotechnologies GRCL, each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Earnings of Gracell Biotechnologies beat estimates in two of the trailing four quarters, missed the mark on one occasion while meeting the mark on another. On an average, the company has reported a negative surprise of 62.71%. In the last reported quarter, Gracell Biotechnologies’ earnings beat estimates by 18.92%.
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