Sun Pharmaceutical Industries has achieved a significant regulatory milestone with the US Food and Drug Administration's acceptance of its supplemental biologics license application for Ilumya® (tildrakizumab-asnm). The FDA has accepted the sBLA for review to expand the therapeutic scope of this biologic therapy to include treatment of adults diagnosed with active psoriatic arthritis, with a regulatory action date expected by October 29, 2026.

Regulatory Application Details

The FDA acceptance marks an important step in the regulatory process for expanding Ilumya's approved indications. This sBLA specifically covers the treatment of adults with active psoriatic arthritis, building on the established clinical experience of Ilumya as an IL-23 inhibitor for moderate-to-severe plaque psoriasis.

Clinical Trial Foundation

The sBLA submission is based on results from the INSPIRE-1 and INSPIRE-2 Phase 3 clinical studies evaluating the efficacy and safety of Ilumya in adult patients with active psoriatic arthritis. Both studies are 52-week global, multicenter, randomized, double-blind, placebo-controlled Phase 3 trials assessing tildrakizumab 100 mg in this patient population. Top-line findings from these studies were reported in July 2025.

Market Position and Patient Impact

If approved, this would represent a significant expansion for Ilumya, which received its original US FDA approval in 2018 for moderate-to-severe plaque psoriasis. The drug has since received additional approvals for scalp and nail plaque psoriasis in April 2024 and December 2025, respectively. Ilumya has supported nearly 140,000 patients worldwide and has received marketing authorization from over 55 worldwide health authorities.

Therapeutic Significance

Psoriatic arthritis affects roughly 1 in 3 people living with psoriasis, with as many as 2.4 million Americans living with the condition. The potential approval would position Ilumya as the only HCP-administered IL-23 biologic for active psoriatic arthritis treatment. Rick Ascroft, CEO of Sun Pharma North America, emphasized the company's ambition for Ilumya to become a differentiated first-choice advanced systemic treatment for this condition.

Sun Pharmaceutical Industries Limited has officially announced its third-quarter results for FY26, demonstrating strong growth across multiple business segments and reinforcing its position as a leading global pharmaceutical company. The Board of Directors approved these results at their meeting held on January 31, 2026.

Financial Performance Overview

The company's consolidated financial results for Q3FY26 showcase robust performance with revenue reaching ₹155.2 billion compared to ₹136.7 billion in the corresponding period last year. The consolidated net profit reached ₹33.6 billion compared to ₹29 billion in the corresponding period last year, marking significant year-on-year growth. Revenue growth was driven by strong performance in branded businesses across India, Emerging Markets, and Global Innovative Medicines.

Segment-wise Performance

India Formulations

The India Formulations business continued its strong momentum with sales of ₹49,986 million, registering growth of 16.2% year-on-year. This segment accounted for 32.3% of total consolidated sales. Sun Pharma maintains its leadership position as India's No. 1 pharmaceutical company, with market share increasing from 8.1% to 8.4% according to Pharmarack MAT December 2025 report. The company launched 12 new products during the quarter.

US Formulations

US Formulations sales reached US$477 million, showing marginal growth of 0.6%. The Innovative Medicines portfolio continued to grow, offsetting declines in the generics business. This segment represented approximately 27.5% of total consolidated sales.

Global Markets Performance

Emerging Markets formulations demonstrated strong growth with sales of US$337 million, up 21.6% year-on-year, accounting for 19.4% of total sales. Rest of World formulations also performed well with sales of US$296 million, growing 14.5% and representing 17.1% of consolidated sales.

Nine-Month Performance Highlights

For the nine-month period ended December 31, 2025, the company maintained consistent growth momentum:

Regulatory Filing and Corporate Actions

The Board of Directors approved an interim dividend of ₹11.00 per equity share of ₹1 each for FY26, representing an increase from the previous year's interim dividend of ₹10.50 per share. The record date for dividend entitlement is February 5, 2026, with payment scheduled on or before February 16, 2026.

Innovation and R&D Focus

Sun Pharma continues to invest significantly in research and development, with R&D expenditure of ₹8,928 million in Q3FY26, representing 5.8% of sales. The company's innovative R&D pipeline includes five novel entities in clinical stage, with 57 approved NDAs and 14 NDAs awaiting US FDA approval. The Global Innovative Medicines business achieved sales of US$423 million, including a US$55 million milestone payment, with ex-milestone sales growing 13.2%.

Earnings Call Recording Available

Pursuant to Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, the company has made available the audio recording of the earnings call held on January 31, 2026. The recording can be accessed on the company's website for investors and stakeholders seeking detailed insights into the quarterly performance and management commentary.