PaxMedica (NASDAQ: PXMD) Completes Key Step in Preparation of PAX-101 for NDA Submission to FDA

April 24, 2024 09:37:50

PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, has made a key announcement regarding the development of its proprietary PAX-101, an IV formulation of suramin. According to the announcement, the company has completed execution of three pivotal registration/validation batches of PAX-101. The company noted that the completion is an “important milestone” in enabling a New Drug Application (“NDA”) submission to the U.S. Food and Drug Administration (FDA), which it plans to complete by the last quarter of 2024. The NDA, along with the approval of the FDA, is a strategic step in the company’s efforts to make the first and only form of suramin for the treatment of stage 1 Human African Trypanosomiasis (“HAT”) available commercially in the United States. HAT is caused by Trypanosoma brucei rhodesiense, a fatal, neglected tropical disease.

To view the full press release, visit https://ibn.fm/2Xcth

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. The company’s 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. Additionally, the company 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 the company’s 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. For more information about the company, visit www.PaxMedica.com.

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