This SPA agreement marks an important milestone in the development of Descartes-08 for MG, providing critical regulatory clarity and a clear path toward potential approval,” said Carsten Brunn, Ph.D., ...

HURA READ THE FULL HURA RESEARCH REPORT We are initiating coverage of TuHURA Biosciences, Inc. (NASDAQ:HURA) with a valuation ...

Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...

FDA, under the Special Protocol Assessment, SPA, process on the overall design of the Company’s planned Phase 3 AURORA trial for Descartes-08, its lead mRNA cell therapy candidate, in myasthenia ...

missing collection of protocol-specified safety laboratory values; and incorrectly performed efficacy endpoint assessment procedures. We have summarized the guidance below, for which FDA invites ...

FREDERICK, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering ...

The Special Protocol Assessment or SPA agreement confirms that ... Descartes-08 has received Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation from the FDA for MG ...