• Key Guidance Regarding NDA Filing Obtained

 PaxMedica, Inc. (NASDAQ:PXMD), a clinical-stage biopharmaceutical company, announced the completion of a type-B meeting with the FDA. During the live meeting, the company discussed the positive results of the recent data from its PAX-HAT-301 study of suramin in Stage One Human African Sleeping Sickness caused by Trypanosoma brucei rhodesiense, a rare and fatal parasitic disease if left untreated.

PaxMedica has received constructive feedback which will aid in the completion of the remaining work necessary to file a New Drug Application (NDA) expected in the second half of 2024. Most of the work to achieve this important milestone will focus on completing the production of commercial lots of PAX-101 under CMC regulatory guidelines, underway now and scheduled to conclude in the first half of 2024.

"This is an important turning point for our young company, and we are very pleased with the guidance that the FDA has provided us in this meeting. We look forward to urgently completing the necessary steps in the coming months to clear the path to submit our first NDA for PAX-101," said Howard Weisman, CEO, and Chairman of PaxMedica.

For further updates and information, please visit PaxMedica's official website at www.paxmedica.com.