Aurobindo Pharma Limited announced on February 13, 2026, that its wholly owned step-down subsidiary Acrotech Biopharma Inc. has received US FDA approval for ADQUEY™ (difamilast 1%) ointment. This approval marks a significant milestone in dermatology treatment, offering a new therapeutic option for mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 and older.

FDA Approval Details

The US Food and Drug Administration has approved the New Drug Application (NDA) for ADQUEY, a novel, non-steroidal, topical phosphodiesterase 4 (PDE4) inhibitor. This approval was achieved through collaboration with Otsuka Pharmaceutical Co., Ltd., which discovered and developed difamilast and licensed it to Acrotech in the United States since 2021.

Clinical Trial Results and Safety Profile

FDA approval was supported by multiple studies including pivotal Phase III controlled trials. The clinical data demonstrated that a significantly greater proportion of patients treated with ADQUEY achieved Investigator's Global Assessment (IGA) success compared to vehicle (placebo) after four weeks of treatment.

The safety profile remained consistent across all three trials, with the most common adverse reaction being nasopharyngitis at 6%. Less common adverse reactions (< 1%) included application site folliculitis, contact dermatitis, application site rash, and molluscum contagiosum.

Market Impact and Leadership Commentary

Ashish Anvekar, President of Acrotech Biopharma Inc., emphasized the significance of this approval: "The approval of ADQUEY represents a significant milestone in our commitment to advancing dermatology care. Patients and clinicians have long sought effective, long-term, non-steroidal treatments that can manage both the inflammation and pruritus associated with eczema."

This approval addresses an important unmet medical need, as atopic dermatitis affects millions of Americans. The condition, also called eczema, is a common and chronic condition that causes itchy, dry, and inflamed skin, usually beginning in childhood but potentially starting at any age.

About the Companies

Actotech Biopharma Inc. serves as a step-down subsidiary of Aurobindo Pharma Ltd and operates as a global platform to commercialize innovative proprietary medications. The company focuses on launching scientifically advanced products to address unmet needs and deliver value to patients and healthcare stakeholders.

Aurobindo Pharma Limited is an integrated global pharmaceutical company headquartered in Hyderabad, India, with operations spanning over 150 countries. The company operates 31 manufacturing and packaging facilities approved by leading regulatory agencies including USFDA, UK MHRA, EDQM, Japan PMDA, WHO, and Health Canada.

Aurobindo Pharma Limited published newspaper advertisements of its unaudited financial results for the third quarter and nine months period ended December 31, 2025, in Business Standard and Nava Telangana on February 11, 2026. The pharmaceutical company formally communicated this publication through official letters to both the National Stock Exchange of India Limited and BSE Limited.

Newspaper Publication Details

The company fulfilled its regulatory obligations by publishing the Q3FY26 financial results in leading newspapers. Company Secretary B. Adi Reddy signed the communication letters sent to stock exchanges, confirming the newspaper advertisement publication.

Strong Q3FY26 Consolidated Financial Performance

The published results highlight robust consolidated financial performance with total income from operations reaching ₹86,459.0 million, representing significant year-over-year growth. Net profit after tax stood at ₹9,098.0 million, while total comprehensive income for the period reached ₹11,375.3 million.

Standalone Results Performance

The standalone financial results showed total income from operations of ₹27,472.8 million for Q3FY26, while net profit after tax reached ₹5,820.7 million. The standalone earnings per share stood at ₹10.02 for the quarter.

Nine Months Performance Highlights

For the nine months period ended December 31, 2025, consolidated total income reached ₹2,47,997.4 million with net profit of ₹25,821.3 million. The comprehensive income for the nine months period totaled ₹37,567.7 million, demonstrating sustained business growth across multiple quarters.