Beam Therapeutics Secures FDA Regenerative Medicine Advanced Therapy Designation for BEAM-101 in Sickle Cell Disease Treatment
Reuters
Aug 14
Beam <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Secures FDA Regenerative Medicine Advanced Therapy Designation for BEAM-101 in Sickle Cell Disease Treatment
Beam Therapeutics Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational genetically modified cell therapy, BEAM-101, for the treatment of sickle cell disease. This designation, following the earlier orphan drug designation in June, underscores the potential of BEAM-101 as a transformative therapy for severe sickle cell disease. The RMAT designation will facilitate enhanced collaboration with the FDA as Beam Therapeutics progresses toward a Biologics License Application $(BLA.AU)$ filing. With updated data from the BEACON Phase 1/2 trial expected by the end of the year, Beam Therapeutics continues to focus on delivering this promising treatment to patients.
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