PaxMedica (OTC: PXMD), a biopharmaceutical company specializing in neurological disorders, is preparing to submit a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for using suramin to treat Human African Trypanosomiasis (“HAT”), a well-established treatment in East Africa for nearly a century. A recent article discussed PaxMedica gearing up for a significant Type C meeting it had with the FDA, which “is critical for the advancement of PAX-101, the company’s leading drug candidate for treating autism, as it progresses through the regulatory framework… For PaxMedica, this Type C meeting is a strategic opportunity to engage with FDA experts and discuss the development steps required for PAX-101… It provides a platform to align with the FDA on crucial aspects concerning PAX-101, an intravenous formulation of suramin with the potential to treat serious conditions like HAT and Autism Spectrum Disorder (‘ASD’). By engaging with the FDA, PaxMedica aims to clarify the regulatory pathways and address any potential hurdles in the clinical trial process, which are essential to bringing PAX-101 closer to market approval.” the article reads. “We are not just continuing; we are intensifying our efforts to achieve significant milestones for these programs by the end of this year. We are on track to submit an NDA for PAX-101, and potentially secure an FDA Priority Review Voucher if approved,” said PaxMedica CEO Howard Weisman.
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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.
NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://ibn.fm/PXMD
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