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Biopharma Stocks in Play - PaxMedica, Inc. (NASDAQ: PXMD) Soars on milestone enabling New Drug Application (NDA) to FDA

 

April 12, 2024 (Investorideas.com Newswire) Investorideas.com (www.investorideas.com), a go-to platform for big investing ideas, including biotech and pharma stocks reports on breaking news on biopharma stock PaxMedica, Inc. (NASDAQ:PXMD), focused on advancing treatments for neurological disorders.

PaxMedica made the NASDAQ top percentage gainers on news, trading at 0.8600, gaining 0.4450, up an impressive 108.5631% , with a day's high of $1.19. The stock has traded over 100 Million shares compared to average daily volume of 204,000.

PaxMedica, today announced the completed execution of its three pivotal registration/validation batches of PAX-101, an IV formulation of suramin. This achievement is an important milestone to enabling a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA), which is currently planned for Q4 2024, and for the potential commercial availability in the U.S. of the first and only form of suramin for the treatment of Stage 1 Human African Trypanosomiasis (HAT), caused by Trypanosoma brucei rhodesiense, a fatal, neglected tropical disease, if approved by the FDA.

From the news :Reaching this milestone is critical to PaxMedica's journey towards potential FDA approval for PAX-101, currently the accepted standard of treatment outside the United States for the deadliest cause of HAT, according to the CDC. A successful review and approval of the NDA could further qualify the company for a Tropical Disease Priority Review Voucher (PRV). PaxMedica plans to fund a sustainable global supply chain for PAX-101, and further advance research and clinical trials to address Autism Spectrum Disorder. This underscores the company's commitment to tackling some of the most challenging neurological conditions.

"This is a very significant milestone for PaxMedica as it endeavors to move PAX-101 towards an NDA submission," said Howard Weisman, chairman and CEO of PaxMedica. "The long-term vision for PaxMedica is to further clinical investigation of PAX-101 as a treatment for individuals who struggle with Autism Spectrum Disorder. With this important manufacturing milestone completed, we have removed a major impediment to testing PAX-101 as a treatment for the core symptoms of Autism Spectrum Disorder. This also progresses us towards our goal of being able to be a consistent and reliable global source of this lifesaving drug for the treatment of HAT currently listed as one of the World's Essential Medicines. It is our goal to ultimately conduct clinical trials for the use of PAX-101 in the treatment of the core symptoms of Autism Spectrum Disorder. There are currently no approved medications for the core symptoms Autism Spectrum Disorder."

https://finance.yahoo.com/news/paxmedica-achieves-key-milestone-development-203000354.html

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