NSEUpdates2d ago · 18 Aug 2026, 08:40 am

Updates

Biocon Limited · BIOCON

✦ AI Summary▲ PositiveProduct Launch

Biocon Limited's US subsidiary has received US FDA approval for Yesintek (ustekinumab-kfce) single-dose prefilled autoinjector, expanding its immunology product portfolio in the US.

Analysis Scores

Earnings Impact6/10
Growth Catalyst8/10
Governance Concern1/10
Regulatory Risk1/10
Balance Sheet Risk1/10
Liquidity Impact8/10
Market Sentiment9/10

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Full Announcement

Biocon Limited has informed the Exchange regarding 'Company Statement'.

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BIOCON_18082026083950_CoStatement18062026.pdf

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Biocon Limited 20th KM, Hosur Road Electronic City Bangalore 560 100, India T 91 80 2808 2808 F 91 80 2852 3423 CIN : L24234KA1978PLC003417 www.biocon.com BIO/SECL/TG/2026-27/60 August 18, 2026 To To The Manager, The Manager, BSE Limited National Stock Exchange of India Limited Department of Corporate Services Corporate Communication Department Phiroze Jeejeebhoy Towers, Exchange Plaza, Bandra Kurla Complex Dalal Street, Mumbai – 400 001 Mumbai – 400 051 Scrip Code - 532523 Scrip Symbol - BIOCON Subject: Company Statement Dear Sir/Madam, Please find enclosed Company Statement w.r.t. “Biocon Announces U.S. FDA Approval for Yesintek® (ustekinumab-kfce) Single-dose Prefilled Autoinjector”. The above information will also be available on the website of the Company at www.biocon.com. Kindly take the same on record and acknowledge. Thanking You, Yours faithfully, For Biocon Limited Rajesh U. Shanoy Company Secretary and Compliance Officer M. No.: ACS 16328 Encl: Company Statement NOTIFICATION TO STOCK EXCHANGE COMPANY STATEMENT Biocon Announces U.S. FDA Approval for Yesintek® (ustekinumab-kfce) Single-dose Prefilled Autoinjector Bengaluru, Karnataka, India, August 18, 2026 Biocon Limited’s subsidiary in the United States has received supplemental U.S. Food and Drug Administration (FDA) approval for Yesintek® 45 mg/0.5 ml single-dose prefilled autoinjector and Yesintek® 90 mg/ml single-dose prefilled autoinjector. Yesintek® was originally approved by the U.S. FDA on November 29, 2024. The Yesintek® single-dose prefilled autoinjector offers patients with another important treatment option. This new delivery format supports more tailored treatment approaches across different care settings and patient needs. Yesintek® is indicated for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients 6 years of age and older, and moderate to severely active Crohn’s disease and ulcerative colitis in adults—a range of debilitating autoimmune conditions that affects tens of thousands of Americans. This supplemental approval enhances Biocon’s comprehensive portfolio of immunology products in the United States and reaffirms the company’s commitment to improving access to affordable medicines for patients around the world. – Company Spokesperson