Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
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., ...
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Cartesian Therapeutics Announces FDA Special Protocol Assessment Agreement for Phase 3 AURORA Trial of Descartes-08 in Myasthenia Gravis
FREDERICK, Md., Jan. 27, 2025 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering ...
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Cartesian Therapeutics announces FDA agreement for new trial
Cartesian Therapeutics has secured an agreement from the US Food and Drug Administration (FDA) under the Special Protocol ...
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Cartesian Therapeutics Receives FDA Agreement on Phase 3 Trial Design for Descartes-08 in Myasthenia Gravis
Cartesian Therapeutics, Inc. announced that it received FDA agreement on the design of its upcoming Phase 3 AURORA trial for Descartes-08, an mRNA cell therapy intended for treating myasthenia ...
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Cartesian Therapeutics Secures FDA SPA Agreement For Phase 3 AURORA Trial
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 ...
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Quince Therapeutics Announces Frontiers in Neurology Publication of Long-Term Safety of EryDex in Pediatric Patients with Ataxia-Telangiectasia
Quince Therapeutics, Inc. , a late-stage biotechnology company dedicated to unlocking the power of a patient's own biology for the treatment of rare diseases, announced the online publication of ...