Sun Pharmaceutical Industries Limited has informed the Exchange regarding a press release dated March 16, 2026, titled "Sun Pharma Announces US FDA Acceptance of Supplemental Biologics License (sBLA) Application for ILUMYA® (tildrakizumab-asmn) for the Treatment of Adults with Active Psoriatic Arthritis".
SUNPHARMA · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
The US FDA has accepted Sun Pharma's supplemental Biologics License Application (sBLA) to expand the use of ILUMYA (tildrakizumab-asmn) to treat adults with active psoriatic arthritis. ILUMYA is currently approved in the US for moderate-to-severe plaque psoriasis since 2018, with scalp and nail psoriasis sBLAs approved in April 2024 and December 2025. The FDA decision on the new indication is expected by October 29, 2026. The application is supported by the INSPIRE-1 and INSPIRE-2 Phase 3 studies, which reported positive top-line results in July 2025. Roughly 1 in 3 psoriasis patients develops psoriatic arthritis, and nearly 140,000 patients have already been treated with ILUMYA worldwide.
This is a positive regulatory milestone that could meaningfully expand ILUMYA's addressable market in the US, supporting Sun Pharma's innovative medicines business, which contributes about 20% of company sales. Approval would likely drive long-term revenue growth, though the actual benefit depends on the FDA's decision in October 2026.