Cartesian Therapeutics, Inc. (RNAC) has announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Descartes-08, aimed at treating myasthenia gravis. Previously, Descartes-08 had received Orphan Drug Designation for the same condition. The company indicates that it remains on schedule to announce topline data from its Phase 2b randomized, double-blind, placebo-controlled trial in patients with myasthenia gravis by mid-2024.
Carsten Brunn, CEO of Cartesian, expressed enthusiasm about collaborating closely with the FDA to expedite the development of Descartes-08 for this underserved patient population.
In response to this news, shares of Cartesian have risen by 4% in pre-market trading on Wednesday.
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