On June 19, Caladrius Biosciences’ stock price rose 67.3% and reached $6.61 from the previous close of $3.95 on June 18.
On June 19, Caladrius Biosciences stock closed at $6.61, which reflected ~160% growth from its 52-week low of $2.63 on November 2, 2017. Caladrius Biosciences hit its 52-week high of $6.84 on June 19.
Reason for the higher stock price
On June 19, the FDA granted RMAT (regenerative medicine advanced therapy) designation to Caladrius Biosciences’ late-stage CD34+ cell therapy program to treat refractory angina.
The RMAT designation is granted by the FDA to regenerative medicine therapies. In preliminary clinical evidence, the medicine therapies indicate the potential to address an unmet medical need for a serious medical condition.
The RMAT designation accelerates the review of marketing applications, shortens the Biologics License Application, and increases meeting opportunities with regulatory authorities.
In March, Caladrius Biosciences acquired the exclusive worldwide license to the late-stage CD34+ program from Shire (SHPG).
Studies estimate that around one million individuals in the United States have chronic symptomatic coronary artery disease or refractory angina, which aren’t managed by conventional revascularization processes.
Two analysts tracking Caladrius Biosciences in June recommended a “buy.” On June 19, Caladrius Biosciences had a consensus 12-month target price of $9.5, which represents a return on investment of ~43.7% in the next 12 months.
On June 19, Alnylam Pharmaceuticals and Incyte had consensus 12-month target prices of $148.19 and $83.14, respectively, which represents a return on investment of ~41.7% and ~13.0% in the next 12 months.