BEAM GAINS FDA REGENERATIVE MEDICINE ADVANCED THERAPY STATUS FOR SICKLE CELL TREATMENT
- The U.S. FDA has issued Regenerative Medicine Advanced Therapy designation to Beam Therapeutics' (NASDAQ:BEAM) BEAM-101, a genetically modified cell therapy for sickle cell disease.
- Shares are up ~4% in premarket trading Thursday.
- The asset has previously been given orphan drug status in June.
- BEAM-101 is intended as a one-time treatment.
- Beam plans to release updated data from the BEACON Phase 1/2 trial by the end of the year.
More on Beam Therapeutics
- Beam Therapeutics: Progress Of BEAM-101 Presses Forward With H2 2025 Data Releases
- Beam Therapeutics: A Cautious Hold On A Base Editing Pioneer
- Beam reports positive results from sickle cell disease treatment
- RFK Jr. looks to fast track rare disease drug approvals (updated)
- Seeking Alpha’s Quant Rating on Beam Therapeutics