10:39 AM EDT, 05/22/2024 (MT Newswires) -- Cartesian Therapeutics ( RNAC ) said Wednesday that the US Food and Drug Administration has granted regenerative medicine advanced therapy designation for Descartes-08 for the treatment of myasthenia gravis, an autoimmune disorder that causes muscle weakness and fatigue.
The RMAT designation offers sponsor companies the advantages of the fast track and breakthrough therapy designation programs, allowing frequent interactions with the regulator, and expediting the drug development process, the company said.
Cartesian added that it is on track to report topline data from its phase 2b trial of Descartes-08 in myasthenia gravis in mid-2024.
Descartes-08 was previously granted FDA's orphan drug designation for the treatment of the same indication, the firm said.
Shares of Cartesian Therapeutics ( RNAC ) rose past 8% in recent trading.
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