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BioMedNewsBreaks – PaxMedica Inc. (NASDAQ: PXMD) Clearing Path to Submit NDA for PAX-101

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.”

To view the full press release, visit https://ibn.fm/wT1eM

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.

NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://ibn.fm/PXMD

About BioMedWire

BioMedWire (“BMW”) is a specialized communications platform with a focus on the latest developments in the Biotechnology (BioTech), Biomedical Sciences (BioMed)and Life Sciences sectors. It is one of 60+ brands within the Dynamic Brand Portfolio @ IBN that delivers: (1) access to a vast network of wire solutions via InvestorWire to efficiently and effectively reach a myriad of target markets, demographics and diverse industries; (2) article and editorial syndication to 5,000+ outlets; (3) enhanced press release enhancement to ensure maximum impact; (4) social media distribution via IBN to millions of social media followers; and (5) a full array of tailored corporate communications solutions. With broad reach and a seasoned team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that want to reach a wide audience of investors, influencers, consumers, journalists and the general public. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled recognition and brand awareness.

BMW is where breaking news, insightful content and actionable information converge.

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