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PaxMedica, Inc. (PXMD) is a clinical-stage biopharmaceutical company pioneering anti-purinergic therapies for neurological disorders and neglected tropical diseases. This page provides investors and healthcare stakeholders with essential updates on clinical trial progress, regulatory developments, and therapeutic innovations.
Access consolidated information on PaxMedica's investigational programs, including its intravenous suramin formulation targeting Autism Spectrum Disorder (ASD) and Human African Trypanosomiasis (HAT). Track critical milestones such as FDA submissions, manufacturing advancements, and responses to global health emergencies.
Key updates include clinical trial results, partnership announcements, intellectual property developments, and analyses of therapeutic mechanisms. This resource eliminates fragmented research by providing verified information directly from company releases and trusted third-party coverage.
Bookmark this page for streamlined monitoring of PaxMedica's progress in developing treatments for complex neurological conditions and tropical diseases. Check regularly for authoritative updates reflecting the company's commitment to addressing unmet medical needs through rigorous scientific research.
PaxMedica (OTC PINK:PXMD) has received its first patent allowance in China for a novel intranasal formulation of suramin to treat autism spectrum disorder and other neurological conditions. The patent (Application No: 2020800553323) covers claims for treating neurological disorders using intranasal delivery of suramin, representing a significant departure from its traditional infusion dosing method.
This marks the first time in over 100 years that intellectual property protection has been granted for any form of suramin. The company has similar patent applications pending in multiple jurisdictions, including the United States, as it continues to expand its intellectual property portfolio.
PaxMedica (OTC PINK:PXMD), a clinical-stage biopharmaceutical company, has announced agreements for the immediate exercise of warrants to purchase up to 4,423,080 shares of common stock. The warrants, originally issued in November 2023 with an exercise price of $1.30 per share, will now be exercised at a reduced price of $0.20 per share. In exchange, PaxMedica will issue new unregistered warrants to purchase up to 8,846,160 shares of common stock at $0.20 per share, exercisable immediately with a five-year term.
The company expects to raise gross proceeds of $884,616 from this transaction, which will be used for the development of PAX-101, working capital, and general corporate purposes. H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering, which is expected to close around September 4, 2024.
PaxMedica (OTC: PXMD) has announced a significant milestone in its global health efforts. The first patient with Human African Trypanosomiasis (HAT), or African Sleeping Sickness, has been treated with PAX-101, an intravenous form of Suramin, in Malawi. This comes after the Malawi Ministry of Health made an emergency request for PaxMedica to provide access to PAX-101 due to a critical global shortage of Suramin.
The company has also received feedback from the U.S. FDA on plans to establish a patient registry in Malawi to document treatment outcomes with PAX-101. This registry will support the upcoming New Drug Application (NDA) for PAX-101 in treating Stage 1 HAT. PaxMedica expects to submit the NDA in the near future, using data from the PAX-HAT-301 Real World Evidence Phase 3 study as a historical control.
PaxMedica has filed an appeal against Nasdaq's decision to delist the company. The appeal follows recent achievements, including the completion of pivotal batches of PAX-101, an urgent request from Malawi for emergency access to the treatment, and the submission of a briefing book for an upcoming FDA Type C meeting.
PaxMedica is optimistic that these developments will support its case to remain listed on Nasdaq. The company stresses its commitment to addressing global health challenges and advancing treatments for neurological disorders. However, PaxMedica acknowledges the uncertainty surrounding the appeal outcome.
PaxMedica, Inc. provided a corporate update, confirming its commitment to advancing treatments for neurological disorders despite transitioning off the NASDAQ stock market. The company is moving forward with the NDA submission for PAX-101 and exploring anti-purinergic therapies for autism spectrum disorder. PaxMedica is also preparing to file an NDA for suramin to treat Human African Trypanosomiasis, responding to a health crisis in Malawi. The CEO assured intensified efforts to achieve milestones by year-end, including potentially securing an FDA Priority Review Voucher.