Cellectis Announces FDA Grants Orphan Drug Designation To CLLS52 (Alemtuzumab) For Lymphodepletion Regimen In UCART22, Evaluated In BALLI-01 Clinical Trial For Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
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Cellectis announced that the FDA has granted Orphan Drug Designation to CLLS52 (Alemtuzumab) for its lymphodepletion regimen in UCART22, which is being evaluated in the BALLI-01 clinical trial for relapsed/refractory B-Cell Acute Lymphoblastic Leukemia.
August 01, 2024 | 9:03 pm
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Cellectis received FDA Orphan Drug Designation for CLLS52 (Alemtuzumab) in its UCART22 lymphodepletion regimen, which is being evaluated in the BALLI-01 clinical trial for relapsed/refractory B-Cell Acute Lymphoblastic Leukemia.
The FDA Orphan Drug Designation is a significant regulatory milestone that can provide benefits such as market exclusivity, tax credits, and fee waivers. This is likely to positively impact Cellectis' stock price in the short term.
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