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PaxMedica, Inc. (NASDAQ: PXMD) is a clinical-stage biopharmaceutical company focusing on the development of innovative anti-purinergic drug therapies (APT) for treating challenging neurological disorders. The company's primary focus is on Autism Spectrum Disorder (ASD) and Human African Trypanosomiasis (HAT). Through its pioneering drug program, PAX-101, an intravenous suramin formulation, PaxMedica aims to provide effective treatment solutions for these conditions.
PaxMedica's recent achievements include the completion of three pivotal registration/validation batches of PAX-101. This milestone is crucial for the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), planned for the fourth quarter of 2024. If approved, PAX-101 will become the first and only form of suramin available in the U.S. for treating Stage 1 HAT, a fatal disease caused by Trypanosoma brucei rhodesiense.
In response to an urgent request from the Ministry of Health in Malawi, PaxMedica has expedited the provision of PAX-101 to address a critical shortage of medications for treating HAT. This initiative highlights the company's commitment to addressing global health crises and ensuring a steady supply of essential drugs.
The company's research efforts extend beyond ASD and HAT, exploring potential therapeutic applications for related neurologic conditions. PaxMedica aims to advance its clinical trials and develop treatments that target the core symptoms of ASD, providing hope and support to millions of affected individuals and their families.
Financially, PaxMedica recently announced a public offering, raising approximately $7.0 million. The funds are intended to repay outstanding debts, advance development programs, and support general corporate purposes. Additionally, the company has transitioned off the NASDAQ stock market, emphasizing that this change will not affect its commitment to advancing treatments for neurological disorders.
To stay updated on PaxMedica's latest news and developments, interested investors and shareholders are encouraged to sign up for email alerts on the company's website and follow PaxMedica on Twitter and LinkedIn.
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.
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