PaxMedica Receives Emergency Request For IV Suramin From African Health Ministry For Use In Treating Fatal Sleeping Sickness
Portfolio Pulse from Benzinga Newsdesk
PaxMedica, Inc. (NASDAQ: PXMD) has received an emergency request from the Ministry of Health of Malawi for IV suramin (PAX-101) to treat African sleeping sickness amid a drug shortage. The company, focusing on neurological disorders, has completed pivotal batches of PAX-101 and is in discussions with the FDA regarding the impact on its NDA submission plans. PaxMedica's engagement with the FDA also explores the potential for a Priority Review Voucher under the Neglected Tropical Disease program, aiming to ensure a steady supply of suramin.
April 16, 2024 | 8:32 pm
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PaxMedica, Inc. is addressing an emergency request from Malawi for its IV suramin product, PAX-101, to treat African sleeping sickness, while also advancing its regulatory approval process with the FDA.
The emergency request from Malawi for PaxMedica's PAX-101 highlights the critical need for the drug, potentially accelerating regulatory discussions and approval processes. This situation could positively impact PXMD's stock in the short term by increasing its visibility and demonstrating its global health impact. The involvement with the FDA and the potential for a Priority Review Voucher further underscore the significance of PAX-101's development and its importance to PaxMedica's portfolio.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100