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NEWS
FDA Grants Orphan Drug Designation to Cellectis’ CLLS52 (alemtuzumab) For ALL Treatment
Cellectis (NASDAQ: CLLS) announced that the FDA has granted Orphan Drug Designation (ODD) to CLLS52 (alemtuzumab), used in the lymphodepletion regimen for UCART22 in the BALLI-01 clinical trial for relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). The addition of alemtuzumab to the fludarabine and cyclophosphamide regimen has shown sustained lymphodepletion and higher UCART22 cell expansion, leading to greater clinical activity.
Cellectis invented the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody. The CD52 knockout aims to make UCART products resistant to alemtuzumab. ODD status may help expedite and reduce costs for development, approval, and commercialization of CLLS52 for ALL treatment.
Cellectis invented the combination of CD52 knockout UCART cells with a lymphodepleting regimen containing an anti-CD52 antibody. The CD52 knockout aims to make UCART products resistant to alemtuzumab. ODD status may help expedite and reduce costs for development, approval, and commercialization of CLLS52 for ALL treatment.
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Trytosaveabit : Today was a awful day for FDA news of any kind! I think like 1 out of every 5 got any attention the last 2 days.
Jaguar8 OP Trytosaveabit : Yes there are days when it’s hot but these past days, it takes more than a day or so to get attention
Trytosaveabit Jaguar8 OP : Indeed!
annna Trytosaveabit : The company's financial report is out, and it looks good.
annna : The company's financial report is out, and it looks good.
Trytosaveabit annna : Yup!