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BioCardia (BCDA) Soars 168% on FDA Nod to Heart Failure Study
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Shares of BioCardia (BCDA - Free Report) skyrocketed 168.2% on Tuesday after management announced that the FDA approved its proposed late-stage CardiAMP Heart Failure II study protocol. The study will evaluate BioCardia’s CardiAMP cell therapy as a potential treatment for patients with ischemic heart failure.
The proposed primary endpoint of the study is a hierarchical composite assessment — consisting of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient and change in quality of life — with a follow-up duration ranging from 12 to 24 months.
The CardiAMP Heart Failure II study will enroll patients who demonstrate a pre-specified N-terminal pro B-type natriuretic peptide (NT-proBNP) level at baseline. Medicare reimbursement will be available to study participants, which is expected to significantly offset the study’s clinical costs.
Year to date, shares of BioCardia have lost 48.8% compared with the industry’s 24.1% fall.
Image Source: Zacks Investment Research
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 is currently evaluating the CardiAMP cell therapy in the ongoing phase III CardiAMP Heart Failure study in patients with chronic myocardial ischemia. The study has already completed enrolment and final data analysis is expected before this year’s end.
Apart from the CardiAMP cell therapy, BioCardia is evaluating its CardiALLO Allogeneic cell therapy in a phase I/II study as a potential treatment for ischemic heart failure with reduced ejection fraction (HFrEF). The first patient is expected to be treated before 2023-end.
Apellis Pharmaceuticals’ loss estimates for 2023 have narrowed from $4.89 to $4.59 per share in the past 60 days. During the same period, the estimates for 2024 loss per share have narrowed from $2.78 to $1.92. Year to date, Apellis Pharmaceuticals’ shares have lost 6.9%.
Apellis Pharmaceuticals beat earnings estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing a negative earnings surprise of 3.91% on average. In the last reported quarter, APLS reported a negative earnings surprise of 39.29%.
In the past 60 days, estimates for Avid Bioservices’ 2023 loss per share have narrowed from 15 cents to 5 cents. During the same period, the estimates for 2024 earnings per share have risen from 13 cents to 21 cents. Shares of CDMO are down 60.3% in the year-to-date period.
Earnings of Avid Bioservices beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 181.25%. In the last reported quarter, Avid’s earnings beat estimates by 100.00%.
Biohaven’s loss estimate has narrowed from $4.99 to $4.93 per share in the past 30 days. During the same period, the loss estimates per share for 2024 have narrowed from $4.81 to $4.79. Shares of BHVN have surged 114.6% in the year-to-date period.
The earnings of Biohaven beat estimates in two of the last four quarters while missing the mark on the other two occasions, posting a negative average earnings surprise of 29.37%. Biohaven’s earnings missed estimates by 6.45%.
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BioCardia (BCDA) Soars 168% on FDA Nod to Heart Failure Study
Shares of BioCardia (BCDA - Free Report) skyrocketed 168.2% on Tuesday after management announced that the FDA approved its proposed late-stage CardiAMP Heart Failure II study protocol. The study will evaluate BioCardia’s CardiAMP cell therapy as a potential treatment for patients with ischemic heart failure.
The proposed primary endpoint of the study is a hierarchical composite assessment — consisting of all-cause death, the cardiac death equivalents of heart transplant and left ventricular assist device implantation, heart failure hospitalizations, worsening heart failure events treated as an outpatient and change in quality of life — with a follow-up duration ranging from 12 to 24 months.
The CardiAMP Heart Failure II study will enroll patients who demonstrate a pre-specified N-terminal pro B-type natriuretic peptide (NT-proBNP) level at baseline. Medicare reimbursement will be available to study participants, which is expected to significantly offset the study’s clinical costs.
Year to date, shares of BioCardia have lost 48.8% compared with the industry’s 24.1% fall.
Image Source: Zacks Investment Research
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 is currently evaluating the CardiAMP cell therapy in the ongoing phase III CardiAMP Heart Failure study in patients with chronic myocardial ischemia. The study has already completed enrolment and final data analysis is expected before this year’s end.
Apart from the CardiAMP cell therapy, BioCardia is evaluating its CardiALLO Allogeneic cell therapy in a phase I/II study as a potential treatment for ischemic heart failure with reduced ejection fraction (HFrEF). The first patient is expected to be treated before 2023-end.
BioCardia, Inc. Price
BioCardia, Inc. price | BioCardia, Inc. Quote
Zacks Rank & Other Stocks to Consider
BioCardia currently carries a Zacks Rank #2 (Buy).Some other top-ranked stocks in the overall healthcare sector include Apellis Pharmaceuticals (APLS - Free Report) , Avid Bioservices (CDMO - Free Report) and Biohaven (BHVN - Free Report) , also carrying a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Apellis Pharmaceuticals’ loss estimates for 2023 have narrowed from $4.89 to $4.59 per share in the past 60 days. During the same period, the estimates for 2024 loss per share have narrowed from $2.78 to $1.92. Year to date, Apellis Pharmaceuticals’ shares have lost 6.9%.
Apellis Pharmaceuticals beat earnings estimates in two of the last four quarters while missing the mark on the other two occasions, witnessing a negative earnings surprise of 3.91% on average. In the last reported quarter, APLS reported a negative earnings surprise of 39.29%.
In the past 60 days, estimates for Avid Bioservices’ 2023 loss per share have narrowed from 15 cents to 5 cents. During the same period, the estimates for 2024 earnings per share have risen from 13 cents to 21 cents. Shares of CDMO are down 60.3% in the year-to-date period.
Earnings of Avid Bioservices beat estimates in three of the last four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 181.25%. In the last reported quarter, Avid’s earnings beat estimates by 100.00%.
Biohaven’s loss estimate has narrowed from $4.99 to $4.93 per share in the past 30 days. During the same period, the loss estimates per share for 2024 have narrowed from $4.81 to $4.79. Shares of BHVN have surged 114.6% in the year-to-date period.
The earnings of Biohaven beat estimates in two of the last four quarters while missing the mark on the other two occasions, posting a negative average earnings surprise of 29.37%. Biohaven’s earnings missed estimates by 6.45%.