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Posted On: 06/13/2024 4:53:24 PM
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NetworkNewsBreaks – PaxMedica Inc. (NASDAQ: PXMD) Marks Major Milestone in Preparations for NDA Submission, Global Suramin Supply
PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, recently completed its three registration/validation batches of PAX-101, an IV formulation of suramin. “This accomplishment marks a significant step toward submitting a New Drug Application (‘NDA’) to the U.S. Food and Drug Administration (‘FDA’) in the fourth quarter of 2024. This step paves the way for potential commercial availability in the U.S. of suramin, the sole form for treating stage 1 Human African Trypanosomiasis (‘HAT’) caused by Trypanosoma brucei rhodesiense. This disease, fatal and neglected, represents a critical healthcare challenge,” a recent article reads. “This completion of our registration/validation batches is a crucial step as we prepare for an NDA submission for PAX-101. It marks a significant milestone in our ongoing effort,” said Howard Weisman, chair and CEO of PaxMedica. “This manufacturing achievement has significantly aided in overcoming one of the major barriers to initiating further tests on PAX-101 for addressing the core symptoms of autism spectrum disorder (‘ASD’), which remain under investigation. The progress we’ve made brings us closer to our objective of becoming a reliable global supplier of suramin, particularly for treating Stage 1 HAT, a condition for which suramin is recognized as one of the world’s essential medicines.”
NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://nnw.fm/PXMD
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
PaxMedica (NASDAQ: PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, recently completed its three registration/validation batches of PAX-101, an IV formulation of suramin. “This accomplishment marks a significant step toward submitting a New Drug Application (‘NDA’) to the U.S. Food and Drug Administration (‘FDA’) in the fourth quarter of 2024. This step paves the way for potential commercial availability in the U.S. of suramin, the sole form for treating stage 1 Human African Trypanosomiasis (‘HAT’) caused by Trypanosoma brucei rhodesiense. This disease, fatal and neglected, represents a critical healthcare challenge,” a recent article reads. “This completion of our registration/validation batches is a crucial step as we prepare for an NDA submission for PAX-101. It marks a significant milestone in our ongoing effort,” said Howard Weisman, chair and CEO of PaxMedica. “This manufacturing achievement has significantly aided in overcoming one of the major barriers to initiating further tests on PAX-101 for addressing the core symptoms of autism spectrum disorder (‘ASD’), which remain under investigation. The progress we’ve made brings us closer to our objective of becoming a reliable global supplier of suramin, particularly for treating Stage 1 HAT, a condition for which suramin is recognized as one of the world’s essential medicines.”
NOTE TO INVESTORS: The latest news and updates relating to PXMD are available in the company’s newsroom at https://nnw.fm/PXMD
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
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