PaxMedica Appeals Nasdaq Delisting, Prepares for FDA Meeting on PAX-101

May 15, 2024 - PaxMedica, Inc., a biopharmaceutical company specializing in neurological disorder treatments, has filed an appeal with the Nasdaq Office of Appeals and Review regarding its delisting from Nasdaq. This decision follows Nasdaq's notification on April 30th, prompting PaxMedica to challenge the ruling, arguing that the Hearings Panel overlooked significant accomplishments and ongoing efforts to meet listing requirements. 

PaxMedica has enlisted Jacob Frenkel from Dickinson Wright, PLLC as lead counsel for the appeal, supported by the consulting firm previously involved with the Hearings Panel. CEO Howard Weisman emphasized that recent developments, including the completion of PAX-101 registration lots and submission of a briefing book for an FDA Type C meeting, highlight the company's progress and commitment to addressing global health challenges.

Significant milestones for PaxMedica include:
- April 11: Completion of three pivotal registration/validation batches of PAX-101, an IV formulation of suramin, essential for regulatory submissions.
- April 16: An urgent request from Malawi’s Ministry of Health for emergency suramin access to combat a humanitarian crisis due to the shortage of treatment for TBr HAT, a fatal form of African Sleeping Sickness.
- April 23: Agreement to supply Malawi with PAX-101 from existing stock, reinforcing PaxMedica’s role in global health emergencies.
- May 10: Submission of the FDA Briefing Book for the Type C meeting scheduled for June 27, 2024.

Weisman expressed confidence that these developments would support their appeal and lead to the restoration of trading on Nasdaq. Despite this optimism, PaxMedica acknowledges the uncertainty of the appeal's outcome. The company remains focused on maximizing shareholder value and advancing neurological disorder treatments.

PaxMedica is committed to developing innovative treatments for neurological conditions, contributing significantly to public health worldwide. The company’s portfolio includes treatments for neurodevelopmental disorders such as Autism Spectrum Disorder (ASD) and other neurological conditions. PaxMedica also aims to provide a reliable source of suramin, the standard treatment for Stage 1 Trypanosoma brucei rhodesiense.

Central to PaxMedica’s efforts is the development of PAX-101, an intravenous suramin formulation, particularly for innovative ASD treatments. Their research also explores potential therapies for related conditions. 

PaxMedica continues to strive for breakthroughs in neurological disorder treatments, ensuring their contributions positively impact public health on a global scale.

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