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BioCardia (BCDA) Up on Plans for Second Heart Failure Study
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Shares of BioCardia, Inc. (BCDA - Free Report) were up 28.2% on Wednesday after the company completed enrollment in the ongoing pivotal phase III CardiAMP HF study. The study is evaluating its CardiAMP cell therapy for the treatment of heart failure.
BCDA also announced that it is looking to initiate a second pivotal study to evaluate patients who responded well to CardiAMP cell therapy in the initial study.
CardiAMP cell therapy uses a patient's bone marrow cells delivered to the heart via a catheter-based procedure to stimulate the body’s natural healing response.
Last month, BCDA announced interim data from the first phase III study investigating CardiAMP cell therapy for heart failure. Data from the interim analysis showed that the study is unlikely to meet its primary efficacy endpoint based on the three-tiered Finkelstein-Schoenfeld hierarchical analysis of 12-month data.
This announcement also confirmed the validity of the statement made by an independent data safety monitoring board in July 2023. The board said that the study was not likely to meet its primary efficacy endpoint based on an initial analysis of data.
Shares of BioCardia have plunged 76.1% so far this year compared with the industry’s decline of 19.3%.
Image Source: Zacks Investment Research
However, it was observed in the initial study that CardiAMP cell therapy treatment greatly benefited a certain group of patients with high levels of NT-proBNP.
In the study, in patients with NT-pro BNP levels greater than 500 pg/ml at baseline, treatment with CardiAMP cell therapy led to a 59% relative risk reduction in mortality and 54% relative risk reduction of major adverse cardiac events compared with the control group.
NTproBNP is a known biological indicator of increased heart failure and stress to the heart.
Per the company, the new Heart Failure II study will only enroll patients who have an NTproBNP at baseline greater than 500 pg/ml. It will also have a new modified primary endpoint.
Per the latest press release, the company believes that if it had focused on the subset of patients (elevated NT-proBNP at baseline) with the updated composite endpoint, the study would have eventually met the primary endpoint.
In the past 30 days, loss per share estimates for Anixa Biosciences’ 2023 have narrowed from 33 cents to 32 cents. During the same period, the loss estimates per share for 2024 have narrowed from 38 cents to 37 cents. Year to date, shares of ANIX have lost 22.8%.
Earnings of Anixa Biosciences beat estimates in each of the last four quarters, delivering an earnings surprise of 26.29% on average.
In the past 30 days, estimates for CRISPR Therapeutics’ 2023 loss per share have improved from $4.97 to $4.83. During the same period, loss estimates per share for 2024 have narrowed from $6.62 to $6.45. Year to date, shares of CRSP have risen 10.1%.
Earnings of CRISPR Therapeutics beat estimates in each of the trailing four quarters, the average surprise being 39.19%.
In the past 30 days, estimates for Deciphera’s 2023 loss per share have remained stable at $2.36. During the same period, the loss estimates per share for 2024 have also remained stable at $2.17. Year to date, shares of DCPH have declined 33.5%.
Earnings of Deciphera beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, DCPH delivered an earnings surprise of 1.58%.
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BioCardia (BCDA) Up on Plans for Second Heart Failure Study
Shares of BioCardia, Inc. (BCDA - Free Report) were up 28.2% on Wednesday after the company completed enrollment in the ongoing pivotal phase III CardiAMP HF study. The study is evaluating its CardiAMP cell therapy for the treatment of heart failure.
BCDA also announced that it is looking to initiate a second pivotal study to evaluate patients who responded well to CardiAMP cell therapy in the initial study.
CardiAMP cell therapy uses a patient's bone marrow cells delivered to the heart via a catheter-based procedure to stimulate the body’s natural healing response.
Last month, BCDA announced interim data from the first phase III study investigating CardiAMP cell therapy for heart failure. Data from the interim analysis showed that the study is unlikely to meet its primary efficacy endpoint based on the three-tiered Finkelstein-Schoenfeld hierarchical analysis of 12-month data.
This announcement also confirmed the validity of the statement made by an independent data safety monitoring board in July 2023. The board said that the study was not likely to meet its primary efficacy endpoint based on an initial analysis of data.
Shares of BioCardia have plunged 76.1% so far this year compared with the industry’s decline of 19.3%.
Image Source: Zacks Investment Research
However, it was observed in the initial study that CardiAMP cell therapy treatment greatly benefited a certain group of patients with high levels of NT-proBNP.
In the study, in patients with NT-pro BNP levels greater than 500 pg/ml at baseline, treatment with CardiAMP cell therapy led to a 59% relative risk reduction in mortality and 54% relative risk reduction of major adverse cardiac events compared with the control group.
NTproBNP is a known biological indicator of increased heart failure and stress to the heart.
Per the company, the new Heart Failure II study will only enroll patients who have an NTproBNP at baseline greater than 500 pg/ml. It will also have a new modified primary endpoint.
Per the latest press release, the company believes that if it had focused on the subset of patients (elevated NT-proBNP at baseline) with the updated composite endpoint, the study would have eventually met the primary endpoint.
BioCardia, Inc. Price
BioCardia, Inc. price | BioCardia, Inc. Quote
Zacks Rank & Stocks to Consider
BioCardia currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector include Anixa Biosciences, Inc. (ANIX - Free Report) , CRISPR Therapeutics AG (CRSP - Free Report) , and Deciphera Pharmaceuticals, Inc. (DCPH - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, loss per share estimates for Anixa Biosciences’ 2023 have narrowed from 33 cents to 32 cents. During the same period, the loss estimates per share for 2024 have narrowed from 38 cents to 37 cents. Year to date, shares of ANIX have lost 22.8%.
Earnings of Anixa Biosciences beat estimates in each of the last four quarters, delivering an earnings surprise of 26.29% on average.
In the past 30 days, estimates for CRISPR Therapeutics’ 2023 loss per share have improved from $4.97 to $4.83. During the same period, loss estimates per share for 2024 have narrowed from $6.62 to $6.45. Year to date, shares of CRSP have risen 10.1%.
Earnings of CRISPR Therapeutics beat estimates in each of the trailing four quarters, the average surprise being 39.19%.
In the past 30 days, estimates for Deciphera’s 2023 loss per share have remained stable at $2.36. During the same period, the loss estimates per share for 2024 have also remained stable at $2.17. Year to date, shares of DCPH have declined 33.5%.
Earnings of Deciphera beat estimates in three of the trailing four quarters and missed the mark on the other occasion. On average, DCPH delivered an earnings surprise of 1.58%.