FDA grants RMAT status for Cartesian’s Descartes-8

The US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for Descartes-08.

The product is a potential first-in-class mRNA CAR T-cell therapy, for the treatment of myasthenia gravis (MG) under development by US clinical-stage biotech Cartesian Therapeutics (Nasdaq: RNAC), whose shares rose more than 8% to $26.58 on the news.

In a Phase IIa study in patients with MG, the results of which were published in The Lancet Neurology, Descartes-08 demonstrated deep and durable clinical responses. Descartes-08 was administered in an outpatient setting and observed to be well tolerated.