Caladrius Biosciences Inc CLBS shares were trading sharply higher for a second straight session Wednesday after the FDA granted a special status for its CD34+ cell therapy.
What Happened
Caladrius Biosciences announced Tuesday ahead of the market open that the FDA granted regenerative medicine advanced therapy, or RMAT, designation to its late-stage CD34+ cell therapy program for treating refractory angina.
Refractory angina is chronic symptomatic coronary artery disease, with symptoms manifesting as chest pain, shortness of breath and extreme fatigue.
Why It's Important
The designation is usually accorded to therapies intended to treat serious conditions that have the potential to address unmet medical needs.
The designation expedites drug development and the review of marketing applications with increased meeting opportunities; early interactions to discuss potential or surrogate or intermediate endpoints; shortened BLA review times; and the potential of accelerated approval.
What's Next
The CD34+ program, which Caladrius acquired from Shire PLC (ADR) SHPG in March 2018, vests the former with the responsibility of manufacturing, preclinical and Phase 1, 2 and 3 clinical study data for the CD34 cell therapy as a treatment for no-option refractory angina, along with corresponding regulatory filings.
Following a 67.34 percent jump to $6.61 Tuesday, Caladrius shares were trading up 41.45 percent to $9.35 at the time of publication Wednesday morning.
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