suramin intravenous (PAX-101) / PaxMedica - LARVOL DELTA

Randomized clinical trial of low dose suramin intravenous infusions for treatment of autism spectrum disorder. (PubMed, Ann Gen Psychiatry) - P2 | "Suramin was generally safe and well tolerated over 14 weeks; most adverse events were mild to moderate in severity. Trial Registration Registered with the South African Health Authority, registration number DOH-27-0419-6116."

Clinical • Journal • Autism Spectrum Disorder • Genetic Disorders • Inflammation

"$PXMD PaxMedica Initiates Clinical Program to Advance PAX-101 Towards FDA Submission https://t.co/zIdtajW9CT" (@stock_titan)

Clinical • FDA event

Suramin Intravenous Infusion For Treating Boys With Autism Spectrum Disorder: Results Of A 14-Week, Randomized, Double-Blind, Placebo-Controlled, Multidose, Phase 2 Study (AACAP 2021) - "Limitations include the small sample size and exploratory analyses that require confirmation in a larger study. Suramin was safe and tolerable over 14 weeks."

Clinical • P2 data • Autism Spectrum Disorder • CNS Disorders • Epilepsy • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease

PaxMedica Receives FDA Orphan Drug Designation for Use of PAX-101 (IV suramin) in a Rare Tropical Disease (GlobeNewswire) - "PaxMedica is separately pursuing the development of PAX-101 (IV suramin) as a treatment for Autism Spectrum Disorder and other neurodevelopmental conditions and will report findings from its just completed clinical trial in the near future."

Trial completion • Fragile X Syndrome

IPO Launch: PaxMedica Proposes Terms For $15 Million IPO (The Street) - "PaxMedica (PXMD) aims to raise $15 million from the sale of its common stock in an IPO, according to an amended registration statement....We currently expect to use the net proceeds from this offering for product development activities, including clinical and regulatory research and development for our product candidates....Based on our current projections, we believe the net proceeds of this offering will fund our operations through the end of the second fiscal quarter of 2022. At that time, we expect the net proceeds from this offering to have funded...submission of IND applications for the ASD and FXTAS indications."

Financing • Autism Spectrum Disorder • CNS Disorders • Fragile X Syndrome

IPO Preview: PaxMedica Files For $18 Million U.S. IPO (The Street) - "PaxMedica (PXMD) intends to raise $18 million in an IPO of its common stock....The firm's lead candidate, PAX-101, is an intravenous-delivered suramin formulation that it is developing for autism, Fragile X and Human African Trypanosomiasis [HAT]. PAX-101 is currently 60% complete in enrolling patients in a Phase 2b trial in South Africa for the treatment of ASD, with an expectation completion date by the end of 2020 and data readout by ‘early in 2021'....Based on our current projections, we believe the net proceeds of this offering will fund our operations through the end of the second fiscal quarter of 2022."

Clinical data • Financing • Trial status • Autism Spectrum Disorder • CNS Disorders • Fragile X Syndrome