NetworkNewsBreaks — PaxMedica Inc. (NASDAQ: PXMD
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PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, is reporting on its financial results as well as providing a comprehensive business update for the third quarter ended Sept. 30, 2023. Highlights of the report include the successful conclusion of a crucial Type-B meeting with the U.S. Food and Drug Administration designed to gather vital guidance for the NDA submission of PAX-101; the completion of the final PAX-101 phase 3 trials for human African trypanosomiasis (HAT); the strategic acquisition of suramin research assets from Rediscovery Life Sciences (RLS); and the successful completion of a commercial-scale development plan for PAX-101, which shows the company is on track for manufacturing API validation, drug-product validation and registration lots in the first quarter of 2024. The company’s financial report showed a total of $1.2 million in cash reserves with access to the remaining $14.4 million from the company’s committed equity investment agreement, with a total count of common shares issued and outstanding as of the end of the quarter reaching 1,073,815. “The accomplishments in the third quarter of 2023 represent significant progress in our journey towards a 2024 US FDA filing of an NDA for the treatment of HAT with PAX-101 (IV suramin),” said PaxMedica CEO Howard Weisman in the press release. “The favorable results from our retrospective HAT-301 study reinforce the substantial benefits of suramin in treating this life-threatening infection. With these milestones, PaxMedica is well-positioned to expand our research initiatives, including the exploration of PAX-101 for addressing the core symptoms of autism spectrum disorder.”
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