Paxmedica Inc. (NASDAQ: PXMD) Seeking To Qualify For Neglected Tropical Disease Priority Review Voucher Program In Wake Of Malawi Major Sleeping Sickness Crisis

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  • PaxMedica has received an urgent plea from the Ministry of health of Malawi for emergency access to IV suramin to prevent a potential humanitarian crisis due to dwindling supplies of essential drugs used to save lives in the region
  • PaxMedica has previously concluded a Type B meeting with the FDA in preparation for the NDA submission, focusing on the use of PAX-101 in treating the rare and fatal trypanosomal infection, Trypanosoma brucei rhodesiense, transmitted by tsetse flies
  • PaxMedica also aims to potentially qualify for a Priority Review Voucher under the Neglected Tropical Disease Priority Review Voucher Program, which could provide resources to ensure a steady supply of suramin to endemic regions

PaxMedica (NASDAQ: PXMD) , a biopharmaceutical firm dedicated to advancing treatments for neurological disorders, recently announced that it has received an urgent plea from the Ministry of Health (“MOH”) of Malawi. The MOH is requesting emergency access to IV suramin to prevent a potential humanitarian crisis due to dwindling supplies of essential drugs used to save lives in the region ( ).

Following the recent completion of its three pivotal registration/validation batches of PAX-101 (an IV form of suramin), PaxMedica has promptly brought this urgent request to the attention of the U.S. Food and Drug Administration (“FDA”). The company aims to assess any potential impact on its ongoing...

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