Autolus Receives FDA Regenerative Medicine Advanced Therapy Designation for Obecabtagene Autoleucel
MT Newswires Live
Sep 09
Autolus Therapeutics (AUTL) said Wednesday that the US Food and Drug Administration has granted regenerative medicine advanced therapy designation for obecabtagene autoleucel to treat systemic lupus erythematosus and lupus nephritis.
The designation is intended to accelerate the development and regulatory review of regenerative medicine therapies, including cell therapies, to treat serious or life-threatening diseases.
The company said the designation was based on data from the phase 1b CARLYSLE trial in patients with systemic lupus erythematosus.
Shares of the British biotech firm were up 3.8% pre-bell.
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