PaxMedica (NASDAQ: PXMD), a clinical-stage biopharmaceutical company, today announced the completion of a type-B meeting with the FDA. During the live meeting, the company discussed 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. According to the announcement, PaxMedica received constructive feedback that will aid in the completion of the remaining work necessary to file a New Drug Application (“NDA”) expected in the second 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,” said Howard Weisman, CEO and chairman of PaxMedica. “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.”
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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”) designed to address challenging neurologic disorders. Its scope encompasses a spectrum of conditions, from neurodevelopmental disorders, including autism spectrum disorder (“ASD”), to the debilitating myalgic encephalomyelitis/chronic fatigue syndrome (“ME/CFS”), marked by both physical and cognitive burdens. PaxMedica prioritizes the advancement and evaluation of its flagship program, PAX-101—an intravenous suramin formulation—primarily focused on ASD treatment, while also broadening clinical insights into its potential applications for conditions such as ME/CFS. For more information, visit www.PaxMedica.com.
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