Aurobindo Pharma Limited has informed the Exchange regarding a press release dated February 13, 2026, titled "Press Release - Acrotech Biopharma Inc., Announces FDA Approval of ADQUEY (difamilast 1%) Ointment for the Treatment of Mild-to-Moderate Atopic Dermatitis".
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Aurobindo Pharma's wholly-owned step-down subsidiary, Acrotech Biopharma Inc., has received US FDA approval for ADQUEY (difamilast 1%) ointment for the topical treatment of mild-to-moderate atopic dermatitis (eczema) in adults and children aged 2 and older. ADQUEY is a novel, non-steroidal topical PDE4 inhibitor developed in collaboration with Japan's Otsuka Pharmaceutical, which originally discovered the drug and licensed it to Acrotech for the US market in 2021. FDA approval was supported by multiple Phase III clinical trials showing significantly higher Investigator's Global Assessment (IGA) success rates versus placebo after four weeks, with nasopharyngitis (6%) being the most common side effect. Acrotech plans to launch the product in the US as soon as possible, marking Aurobindo's entry into the branded US dermatology space.
This approval opens a new branded specialty revenue stream for Aurobindo in the large US eczema market, with the non-steroidal positioning offering a differentiated treatment option. The launch timeline and eventual market share will be key for assessing its contribution to earnings.