Auxilius Pharma S.A., a biotechnology company set to join the NanoGroup, has successfully completed another stage of its regulatory dialogue with the U.S. Food and Drug Administration (FDA). On 23 July 2026, the Company held a Type C meeting with the FDA’s Division of Cardiology and Nephrology to discuss preparations for the submission of an Investigational New Drug (IND) application for the AUX-001 project.

The meeting was another step in the constructive dialogue Auxilius Pharma has maintained with the FDA since its pre-IND meeting. The main focus of the discussions was to clarify the remaining requirements for the nonclinical development programme necessary to prepare the IND submission. The agreements reached are expected to streamline the preparation and submission of the documentation and facilitate a smooth transition to the next stages of the project’s development. The FDA also confirmed its willingness to continue the dialogue with the Sponsor.

Premier Research International LLC, a global contract research organisation (CRO) and advisory partner with experience in projects pursuing the U.S. 505(b)(2) regulatory pathway, is once again supporting Auxilius Pharma in preparing its regulatory strategy.

AUX-001 is an innovative extended-release formulation of nicorandil being developed for once-daily administration in the treatment of chronic stable angina pectoris (CSAP). An immediate-release formulation of nicorandil has been used to treat this condition outside the United States for decades.

Chronic stable angina pectoris is a common form of symptomatic coronary artery disease, affecting more than 11 million people in the United States and over 16 million in the European Union. Despite the availability of various treatment options, adequate symptom control remains challenging for some patients, and no new pharmacological treatment option specifically intended for this indication has been introduced to the U.S. market for years.

Nicorandil is distinguished by its dual mechanism of action, targeting both the large coronary arteries and the microcirculation. The extended-release formulation being developed by Auxilius Pharma is intended to enable once-daily administration.

“The successful completion of the Type C meeting with the FDA marks a significant milestone in the development of AUX-001 and increases the predictability of the project’s subsequent regulatory steps. For NanoGroup, which is incorporating Auxilius Pharma into its Group, this represents further progress in building the value of its biotechnology portfolio and brings one of its potentially significant assets closer to clinical development and future commercialisation,” comments Przemysław Mazurek, President of the Management Board of NanoGroup.

In the Management Board’s assessment, successful development of AUX-001 and its eventual launch on the U.S. market could contribute to an increase in the value of the entire NanoGroup.

The next stage of work will involve finalising the documentation required for the IND submission and continuing the regulatory dialogue with the FDA.