PaxMedica Achieves Key Milestone in the Development of PAX-101 And Provides Update on Potential NDA Submission
PaxMedica, Inc. (PXMD)
Company Research
Source: GlobeNewswire
TARRYTOWN, New York, April 11, 2024 (GLOBE NEWSWIRE) -- via IBN – PaxMedica, Inc. (NASDAQ:PXMD), a biopharmaceutical company focused on advancing treatments for neurological disorders, 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. 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.
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News
- PaxMedica's CEO and Malawi Health Official Discuss Urgent Medical Crisis in Bell2Bell Podcast [Yahoo! Finance]Yahoo! Finance
- PaxMedica's CEO and Malawi Health Official Discuss Urgent Medical Crisis in Bell2Bell PodcastGlobeNewswire
- PaxMedica Responds to Emergency Request for IV Suramin and Commits to Provide Immediate Access to PAX-101 [Yahoo! Finance]Yahoo! Finance
- PaxMedica Responds to Emergency Request for IV Suramin and Commits to Provide Immediate Access to PAX-101GlobeNewswire
- PaxMedica Receives Emergency Request for IV Suramin from African Health Ministry for Use in Treating Fatal Sleeping Sickness [Yahoo! Finance]Yahoo! Finance
PXMD
Sec Filings
- 4/23/24 - Form 8-K
- 4/16/24 - Form 8-K
- 4/15/24 - Form ARS
- PXMD's page on the SEC website