PaxMedica Meets Key PAX-101 Development Milestone and May Submit NDA

DENVER, Colo., Apr 12, 2024 ( PaxMedica, Inc. (NASDAQ:PXMD) completed three key registration/validation batches of PAX-101, an IV formulation of suramin, an important milestone to enabling a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which the Company plans for late 2024.

“This is a very significant milestone for PaxMedica as it endeavors to move PAX-101 towards an NDA submission,” stated Howard Weisman, chairman and CEO of PaxMedica. “The long-term vision for PaxMedica is to further clinical investigation of PAX-101 as a treatment for individuals who struggle with Autism Spectrum Disorder. With this important manufacturing milestone completed, we have removed a major impediment to testing PAX-101 as a treatment for the core symptoms of Autism Spectrum Disorder. This also progresses us towards our goal of being able to be a consistent and reliable global source of this lifesaving drug for the treatment of HAT currently listed as one of the World’s Essential Medicines. It is our goal to ultimately conduct clinical trials for the use of PAX-101 in the treatment of the core symptoms of Autism Spectrum Disorder. There are currently no approved medications for the core symptoms Autism Spectrum Disorder.”

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