PaxMedica Updates on PAX-101 Regulatory Progress

PaxMedica, Inc., a biopharmaceutical company specializing in neurological disorder treatments, has provided a corporate update following its delisting from the NASDAQ stock market. The company reassures that this transition will not hinder its mission to advance treatments for neurological conditions. CEO Howard Weisman emphasized that PaxMedica remains dedicated to progressing with the New Drug Application (NDA) for PAX-101, which is aimed at addressing the core symptoms of autism spectrum disorder (ASD) through anti-purinergic therapies.

PaxMedica is actively preparing to submit an NDA to the FDA for the use of suramin in treating Human African Trypanosomiasis (HAT). Suramin has been a standard treatment for HAT in East Africa for nearly a century. In April 2024, the company demonstrated its commitment to global health by responding to an urgent request from Malawi for an emergency release of suramin.

Weisman highlighted that the company is intensifying its efforts to achieve significant milestones for their programs by the end of the year. PaxMedica is on track to submit the NDA for PAX-101 and aims to secure an FDA Priority Review Voucher if approved. This proactive strategy underlines PaxMedica’s dedication to advancing healthcare solutions on a global scale.

PaxMedica, Inc. is a clinical-stage biopharmaceutical firm focused on developing anti-purinergic drug therapies (APT) for a variety of challenging neurological disorders. Their portfolio includes treatments for neurodevelopmental conditions such as ASD and other critical areas in neurology. The company's goal is also to provide a reliable source of suramin for treating Stage 1 Trypanosoma Brucei Rhodesiense, a type of HAT.

The company is committed to the continuous development and evaluation of PAX-101, an intravenous suramin formulation that is central to their efforts in finding innovative treatment solutions for ASD. Their ongoing research not only prioritizes ASD patients but also explores potential therapeutic applications for related conditions.

In summary, despite transitioning off the NASDAQ stock market, PaxMedica remains steadfast in its dedication to advancing treatments for neurological disorders. With plans to submit an NDA for PAX-101 and a continued focus on addressing global health challenges like HAT, the company is positioning itself as a significant player in the biopharmaceutical field.

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