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ABIONYX Pharma's CER-001 on Fast Track After Successful FDA Pre-IND Meeting

ABIONYX Pharma completes pre-IND meeting with FDA, plans IND filing for apoA-I-based drug, advancing treatments for sepsis and critical care.

Mrudula Kulkarni
By Mrudula Kulkarni
Managing Editor - Pharma Now
Jun 15, 2024Updated Oct 27, 2025 · 2 min read
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ABIONYX Pharma's CER-001 on Fast Track After Successful FDA Pre-IND Meeting
https://www.linkedin.com/pulse/sepsis-therapeutics-market-ashley-hancock
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Reviewed by Mrudula Kulkarni, Managing Editor - Pharma Now

ABIONYX Pharma (FR0012616852 - ABNX - PEA PME eligible) is a biotech firm focused on developing innovative therapies using the world's only natural recombinant apoA-I, announced today that it has successfully completed a pre-IND (Investigational New Drug Application) meeting with the US FDA and has received feedback supporting an IND filing for its candidate drug.

This is a crucial endorsement of the project's quality and a major move towards including American study centres in upcoming clinical trials. ABIONYX Pharma plans to submit an IND application to the US authorities in the next few months.ABIONYX Pharma is a cutting-edge biotech company dedicated to creating innovative treatments for diseases that currently have no effective or existing therapies, including rare conditions.

Utilizing their deep expertise in lipid science and a unique apoA-I-based technology platform, the company accelerates the development of new therapeutics. ABIONYX Pharma is focused on significantly enhancing treatment outcomes for Sepsis and critical care patients.

 

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Mrudula Kulkarni
Written by
Mrudula Kulkarni
Managing Editor - Pharma Now

My international experience as a researcher in Taiwan for three years has equipped me with a global perspective, enabling me to create content that resonates with an international audience.



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