Brookline Capital Markets launched coverage of BioCardia (NASDAQ:BCDA) with a “buy” rating and $22 price target. Near the close of trading on Nov. 27, the stock was quoted at $4.55.
BioCardia is a developing CardiAMP (BCDA-01), an autologous cell therapy for the treatment of ischemic heart failure. The company is currently enrolling patients in a Phase 3 trial that has partial Centers for Medicare & Medicaid Services reimbursement.
“We foresee a favorable risk-reward and expect the stock price to appreciate as BCDA-01 advances further in the clinic,” writes analyst Kumaraguru Raja, noting that BioCardia’s Phase 2 trial of BCDA-01 met its primary safety endpoint, with secondary endpoints indicating clinically meaningful benefits.
An independent data safety monitoring board recently recommended continuation of the Phase 3 CardiAMP heart failure trial as there were no safety concerns, based on available data.
In addition, BioCardia recently received FDA approval for investigational device exemption supplement for its ongoing Phase 2 heart failure trial. Mr. Raja says that the approval enables patients in the control group to crossover to CardiAMP treatment once their follow-up has been completed, and allows BioCardia to cover all out-of-pocket insurance co-pays for patients with Medicare coverage. “These changes are expected to accelerate enrollment, and clarity on impact of these changes is expected in early 2020,” he added.
Mr. Raja writes that BioCardia is working to make tailored ‘bench-to-bedside’ therapies a reality for cardiac patients and he expects “that continued success would see other big pharmaceutical companies getting interested in the asset.”