Cartesian Therapeutics, Inc. (RNAC) announced the FDA has granted Regenerative Medicine Advanced Therapy designation for Descartes-08 for the treatment of myasthenia gravis. Descartes-08 was previously granted Orphan Drug Designation for the treatment of MG. The company said it remains on track to report topline data from Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG in mid-2024.
Carsten Brunn, CEO of Cartesian, said: "We look forward to working closely with the FDA to efficiently advance the development of Descartes-08 for this underserved population."
Shares of Cartesian are up 4% in pre-market trade on Wednesday.
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