Aurobindo Pharma 's wholly-owned subsidiary CuraTeQ Biologics has announced positive top-line results from its Phase 3 study of BP11, an investigational biosimilar to Xolair (omalizumab). The comprehensive trial successfully met all primary endpoints, demonstrating high comparability to the reference product in patients with chronic spontaneous urticaria at the 300 mg dose.

Clinical Trial Results

The Phase 3 trial was conducted across 608 patients at approximately 80 sites in seven European countries and India. The study evaluated change from baseline in ISS7 (7-point Itch Severity Score) at Week 12, serving as the main primary endpoint applicable for both FDA and EMA approvals.

Results demonstrated precise equivalence with tight confidence intervals well within the predefined margins of -2.50 to 2.00. The co-primary endpoint of relative potency, based on change from baseline in ISS7 at Week 12 using a 4-point assay, also met its criteria, demonstrating parallelism between BP11 and Xolair across dose levels.

Regulatory Strategy and Timeline

Following the successful Phase 3 results, CuraTeQ Biologics has outlined its regulatory filing timeline. The company plans to complete submissions to both major regulatory authorities by the end of Q2 2026.

The results support regulatory submissions targeting chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps (CRSwNP).

Management Commentary

Dr. Arpitkumar Prajapati, Head of Clinical Development, stated that the Phase 3 results with narrow confidence intervals validate the clinical strategy and team execution in delivering a high-quality biosimilar. He noted that detailed results will be submitted for regulatory review and presented at upcoming medical conferences.

Dr. Disha Dadke, Head of R&D and Regulatory Sciences, emphasized that BP11 demonstrates comparable efficacy and safety to Xolair, paving the way for patient access to affordable treatment options.

Market Impact

The successful Phase 3 results position BP11 as a potential competitor in the omalizumab biosimilar market. The outcomes reflect well-contained variability, robustness of data, and strong efficacy alignment with the reference product. Omalizumab is a monoclonal antibody used primarily for treating severe allergic asthma and chronic idiopathic urticaria, representing a significant therapeutic market opportunity for biosimilar alternatives.

Aurobindo Pharma Limited's board has officially approved a significant share buyback proposal worth ₹800.00 crores at its meeting held on April 6, 2026. The pharmaceutical company will repurchase up to 54,23,728 fully paid-up equity shares at ₹1,475.00 per share, representing 0.93% of the total paid-up equity share capital.

Buyback Details and Structure

The board approved the buyback through the tender offer route, targeting all equity shareholders including promoters and promoter group members on a proportionate basis. The buyback will be conducted in accordance with SEBI (Buy-Back of Securities) Regulations, 2018 and the Companies Act, 2013.

The buyback size represents 3.93% and 2.62% of the aggregate total paid-up equity share capital and free reserves as per standalone and consolidated financial statements respectively as at March 31, 2025. Transaction costs including brokerage, fees, taxes, and other expenses are excluded from the buyback size.

Governance and Timeline

The board has constituted a buyback committee with delegated powers to execute all necessary actions for the buyback process. Under SEBI regulations, the board retains flexibility to increase the buyback price and decrease the number of shares until one working day prior to the record date, provided the total buyback size remains unchanged.

Current Shareholding Pattern

As of December 31, 2025, the company's shareholding structure shows promoters and promoter group holding 51.82% with 30,09,48,721 shares. Mutual funds constitute the second-largest category at 19.52% with 11,33,67,285 shares, followed by foreign portfolio investors at 13.94%.

The company will release the public announcement and letter of offer detailing the complete process, timelines, and other requisite information in due course as per regulatory requirements.