Cartesian Therapeutics Soars 22.89% on FDA Trial Design Agreement

On April 17, 2025, Cartesian Therapeutics experienced a significant surge in its stock price, rising by 22.89% in pre-market trading. This notable increase reflects the market's positive response to recent developments and advancements in the company's pipeline.

Cartesian Therapeutics has been actively involved in the development of mRNA cell therapies for autoimmune diseases. In January 2025, the company received a written agreement from the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process. This agreement pertains to the design of the upcoming Phase 3 AURORA trial evaluating Descartes-08, the company’s lead mRNA cell therapy candidate, for treating myasthenia gravis (MG). The SPA confirms that the FDA finds the proposed trial design acceptable to potentially support a future Biologics License Application for Descartes-08, pending successful trial results.

In January 2024, Descartes-08 demonstrated clinically significant improvements in the phase 2a part of a clinical trial for myasthenia gravis. All 7 patients treated with a single infusion of Descartes-08 weekly for 6 weeks showed substantial and lasting clinical improvements in various assessments at 9 months post-treatment. These positive results underscore the potential of Descartes-08 as a promising therapeutic option for myasthenia gravis patients.