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PaxMedica (NASDAQ: PXMD) Announces PAX-101 Batch Completion for NDA Application to FDA

Investor Brand Network - Thu May 2, 8:54AM CDT
  • PaxMedica has completed its three registration/validation batches of PAX-101, an IV formulation of suramin
  • The completed batches are a significant step toward submitting a New Drug Application to the U.S. Food and Drug Administration in the fourth quarter of 2024
  • PaxMedica aims to establish a sustainable global supply chain for PAX-101 and to advance research and clinical trials targeting Autism Spectrum Disorder (“ASD”), demonstrating a steadfast commitment to addressing complex neurological conditions
  • The ASD treatment market size was valued at $6.94 billion in 2022 and is projected to grow to $13.14 billion by 2030

PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, recently announced that it has completed its three registration/validation batches of PAX-101, an IV formulation of suramin. This accomplishment marks a significant step toward submitting a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in the fourth quarter of 2024 (https://ibn.fm/52o4M).

This step paves the way for potential commercial availability in the U.S. of Suramin, the sole form for treating Stage 1 Human African Trypanosomiasis (“HAT”) caused by Trypanosoma brucei rhodesiense. This disease, fatal and neglected, represents a critical healthcare challenge. Pending FDA approval, this…

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