Abionyx: positive response from FDA, share price rises
The biotech company reports that it has successfully passed a meeting with the US health authority, receiving positive feedback regarding the filing of an Investigational New Drug (IND) application.
This is an important validation of the quality of the project, and a significant step towards requesting the inclusion of US study centers in future clinical trials", explains the biotech.
The trial will evaluate its lead candidate, the bacterial scavenger protein CER-001, in the treatment of patients suffering from sepsis, i.e. sepsis.
Abionyx states that it plans to file an IND application with the US health authority in the coming months.
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