$NTRB (+8.0% pre) FDA approves meeting request for Nutriband's fentanyl patch development https://t.co/bN2whgVFBP
Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA $CAPR https://t.co/ZsWgRBlWuC
$CAPR - Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA - https://t.co/FXQdKfQkT5
Cardiol Therapeutics disclosed topline data from its Phase II ARCHER study evaluating CardiolRx, a pharmaceutically manufactured oral cannabidiol solution, in 109 patients with acute myocarditis. After 12 weeks of double-blind treatment, the drug reduced left-ventricular extracellular volume, a marker of myocardial inflammation and fibrosis, with a p-value of 0.0538 versus placebo—just missing conventional statistical significance. No meaningful difference was observed in the second co-primary endpoint, global longitudinal strain. The company said the drop in extracellular volume was accompanied by improvements in several pre-specified cardiac MRI measures, including a significant reduction in left-ventricular mass, and that the therapy was well tolerated. Management called the results “clinical proof of concept” supporting further development of CardiolRx and follow-on candidate CRD-38 in cardiomyopathies and heart failure. A same-day note from Canaccord Genuity highlighted the near-miss on statistical significance and the absence of benefit on the second co-primary measure, cautioning that additional studies may be needed. Cardiol shares fell roughly 17 % intraday following release of the data.