CLBS - Caladrius suspends enrollment in mid-stage study for heart disease candidate
Caladrius Biosciences (NASDAQ:CLBS) has suspended enrollment in a phase 2 trial of Xowna for coronary microvascular dysfunction and will conduct an interim analysis. Shares are up 4% in after-hours trading. The company noted the data from the analysis is likely to provide details on the Xowna effect size that will inform the clinical endpoints likely to be required by the U.S. FDA in a pivotal trial. The analysis is expected to finish in August. Caladrius (CLBS) said only about one-third of the 105 patients it expected in the trial had been enrolled. "The impact of the COVID-19 pandemic in the U.S., coupled with supply chain issues associated with the catheters used for diagnosis of CMD and/or administration of Xowns as well as with a contrast agent typically used in many catheter laboratories, have made and continue to make enrollment much slower than originally predicted and challenging to accelerate," the company said. Seeking Alpha's Quant Rating
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Caladrius suspends enrollment in mid-stage study for heart disease candidate