Concord Biotech shares jump 6% on receiving US FDA approval for its latest arthritis drug

At around 11:03 AM, the stock was trading 4.05% higher at ₹1,323.70 per equity share.

The scrip has advanced 10% in the past week and 13% over the month. On a year-to-date basis, it has fallen 1%.

While the share hit a 52-week high of ₹2,150.40 per unit on June 11, 2025, it touched a year’s low of ₹987 on April 2, 2026.

US FDA approval

The drugmaker said it received the US FDA approval for its ANDA for Tofacitinib tablets, 5 mg and 10 mg, according to a regulatory filing.

Tofacitinib tablets, as per the firm, are indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), active ankylosing spondylitis (AS), moderately to severely active ulcerative colitis (UC), active PsA, and active polyarticular course juvenile idiopathic arthritis (pcJIA).

How big is the Tofacitinib market in the US?

The US market for Tofacitinib tablets, both strengths put together, is estimated to be valued at approximately $500 million, according to market estimates cited by the company.

“The approval positions the company to capitalize on these attractive market opportunities, enhance its product offerings, and support its long-term growth strategy across the U.S. and international markets,” the R&D driven biopharmaceutical said.

Recent update

In a separate filing dated June 2, the pharmaceutical company received approval from the US FDA for its latest Mycophenolate Mofetil drug.

Concord Biotech’s Mycophenolate Mofetil drug is an antimetabolite immunosuppressant (an immune-suppressing medication), which aims to be used to treat organ rejection in adult and pediatric patients of three months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other similar drugs.

Concord Biotech Q4 results

The company posted a 36.8% year-on-year (YoY) fall in its net profit to ₹88.8 crore in the fourth quarter of the 2025-26 financial year (Q4 FY26), compared with ₹140.4 crore in the corresponding quarter last year.

Its revenue from operations declined 24.1% YoY to ₹326.1 crore during the quarter under review, as against ₹429.9 crore in the March quarter of the 2024-25 fiscal year (Q4 FY25).

Concord Biotech has a total market capitalisation of ₹13,848.05 crore as of June 10, 2026, according to data on the NSE.