Recent Publications

WARSAW, BOSTON: We are pleased to announce that on July 23, 2026, Auxilius Pharma successfully conducted a Type C meeting with the FDA's Division of Cardiology and Nephrology. The meeting was requested in the spirit of pragmatic collaboration that has characterized our constructive relationship with the division since our pre-IND meeting. Auxilius Pharma was again supported by Premier Research International LLC (which acquired Camargo Pharmaceutical Services in 2021), a leading global CRO and consulting partner with an unparalleled track record of successfully guiding 505(b)(2) projects from inception to NDA approval.

A key focus of the meeting was advancing preparation for the IND filing for AUX-001. Discussions centered on clarifying any outstanding non-clinical requirements, which we believe will help streamline the path toward filing and support timely advancement of the program. FDA expressed willingness to continue to engage with the Sponsor to support their drug development program. “We had a productive meeting with the FDA and are encouraged and invigorated by the meeting and having cleared this important milestone”, stated Jed Litwiniuk, CEO of Auxilius Pharma.

***

About Chronic Stable Angina

Chronic Stable Angina Pectoris (CSAP) is one of the most common cardiovascular conditions, affecting more than 11 million patients in the US and over 16 million in the EU. It is the most frequent symptomatic manifestation of atherosclerotic coronary artery disease (CAD), characterized by chest pain or discomfort due to inadequate myocardial blood flow in parts of the coronary artery flow bed, typically triggered by physical exertion, emotional stress, or other factors. CSAP prevalence is substantial and rising, with about 650,000 new cases annually in the US. Recent research highlights that a considerable number of chronic angina patients suffer from vascular disease not only of the larger branches of the coronary arteries but simultaneously also from coronary microvascular disease (CMD) which will put further demands on the capability of future anti-angina medications.

The standard first line of care for most patients with stable coronary artery disease underlying chronic angina is optimized medical therapy with anti-anginal medications. In the US, CSAP patients with daily or weekly angina symptoms are on average treated with at least 2 anti-anginal medications to control their symptoms. Despite the availability of various anti-anginal medications (which, for a substantial part of the population, don't adequately control angina symptoms), a substantial part of the CSAP population remains not adequately controlled. Even though the disease represents a major area of unmet medical need, there has been a considerable paucity of developing new anti-angina medications since the last anti-anginal drug launched in the US in 2006.

About AUX-001

AUX-001 is an innovative, once-daily, extended-release formulation of Nicorandil. For decades, immediate-release, twice-daily Nicorandil has been a cornerstone treatment for chronic angina symptoms outside the US. It is distinguished by its dual mechanism of action, targeting both the micro- and macrovascular coronary artery flow bed and providing sustained relief of angina symptoms without the common issue of tachyphylaxis seen with other anti-anginal vasodilators, such as long-acting nitrates. AUX-001 offers efficacy comparable to conventional anti-anginal medications such as beta-blockers, calcium channel blockers, and long-acting nitrates, while also potentially enhancing control of the underlying coronary disease and reducing angina-related hospitalizations, as demonstrated in the IONA study.

About Auxilius Pharma S.A.

Auxilius Pharma is a privately held pharmaceutical company that commenced operations in 2019. Auxilius operates in the space of value-added medicines and brings innovation to areas of high unmet need for patients with diseases such as chronic stable angina pectoris, with the aim of positively impacting public health. Auxilius Pharma's R&D Strategy is driven by patients' need for affordable medications to manage their chronic conditions in the US and in other major markets. The Company has initiated a capital tie-up process with NanoGroup S.A., a company listed on the Warsaw Stock Exchange, focused on innovative normothermic transplant transportation and preservation solutions. The capital operation is designed to strengthen Auxilius' financial position and accelerate pipeline development. Auxilius will continue to operate as an independent company.

About Premier Research International LLC

Premier Research International LLC (Premier) is a global leader in clinical research and consulting services with expertise in driving an efficient and effective path to market for the life sciences industry.

Premier is built with the needs of biotech in mind, turning breakthrough science into life-changing drugs, devices, and diagnostics by addressing trial complexity, overcoming development hurdles, and demonstrating product value.

Leveraging deep therapeutic expertise, innovative technology, and product development operational proficiency—from preclinical planning to clinical trial execution and commercialization—our integrated approach offers personalized, end-to-end solutions to identify the pertinent data and insight necessary to make informed decisions earlier and deliver accelerated development timelines for a smarter, faster path to approval.