Caladrius Biosciences Inc (NASDAQ: CLBS) rose sharply Wednesday, after announcing the company’s CD34+ cell therapy program received Food and Drug Administration regenerative medicine advanced therapy designation for treating refractory angina.
The FDA grants the RMAT designation to regenerative medicine therapies intended to treat a serious condition for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition.
Said Caladrius CEO David Mazzo, "We are delighted and encouraged that the FDA has recognized our CD34+ cell therapy program with an RMAT designation. Refractory angina is a serious condition with high morbidity and no known effective treatments.
"We look forward to working with the FDA to define a path to registration for our therapy with the aim of providing expeditious treatment to patients suffering from this condition."
Caladrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire plc in March of this year. The acquisition included the data set and regulatory filings for the CD34+ cell therapy program for the treatment of refractory angina.
Based in Basking Ridge, New Jersery, Caladrius is a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases.
It is estimated that as many as one million people in the United States have chronic symptomatic coronary artery disease (often referred to as refractory angina) that is recalcitrant to medical therapy and not amenable to conventional re-vascularization procedures.
Shares climbed $2.34, or 35.4%, to $8.95.
