PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, recently 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. 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,” a recent article reads. “This completion of our registration/validation batches is a crucial step as we prepare for an NDA submission for PAX-101. It marks a significant milestone in our ongoing effort,” said Howard Weisman, chair and CEO of PaxMedica. “This manufacturing achievement has significantly aided in overcoming one of the major barriers to initiating further tests on PAX-101 for addressing the core symptoms of autism spectrum disorder (‘ASD’), which remain under investigation. The progress we’ve made brings us closer to our objective of becoming a reliable global supplier of suramin, particularly for treating Stage 1 HAT, a condition for which suramin is recognized as one of the world’s essential medicines.”

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About PaxMedica Inc.

PaxMedica is a forward-looking clinical-stage biopharmaceutical firm specializing in cutting-edge anti-purinergic drug therapies (“APT”) aimed at addressing a range of challenging neurologic disorders. Its comprehensive portfolio encompasses a spectrum of conditions, including neurodevelopmental disorders such as autism spectrum disorder (“ASD”), as well as other critical areas within the neurology field. The company also intends to provide the rest of the world with an additional, reliable source of suramin, the accepted standard of care for stage 1 Trypanosoma brucei rhodesiense. PaxMedica is dedicated to the continuous development and evaluation of its pioneering program, PAX-101, an intravenous suramin formulation that lies at the heart of its efforts, particularly focused on innovative ASD treatment solutions. The company’s ongoing research initiatives not only prioritize the needs of ASD patients but also extend to exploring potential therapeutic applications for related conditions. To learn more about PaxMedica and its transformative work, visit www.PaxMedica.com.

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