The lawsuit, centered on the period between February 13, 2025, and May 14, 2026, highlights statements made by former Chief Operating Officer Bryan Jones. At the May 2025 H.C. Wainwright BioConnect Investor Conference, Jones characterized the ARD-101 safety profile as "very, very clean" with minimal systemic exposure. These assurances were followed by a voluntary pause of the HERO Phase 3 trial in February 2026, citing reversible cardiac observations, and a subsequent full FDA clinical hold in May 2026.

For investors who purchased shares at the $16.00 IPO price, the impact has been severe. The stock dropped to $4.57 by May 15, 2026, representing a loss of over 70% of its initial value. Levi & Korsinsky, LLP, the firm representing the class, argues that the company’s clinical and regulatory prospects were significantly overstated. Investors seeking to participate as lead plaintiff in the litigation have until October 13, 2026, to file with the court.