Concord Biotech Gains USFDA Nod for Multiple Sclerosis Treatment

Concord Biotech has received marketing approval from the United States Food and Drug Administration (USFDA) for its 7 mg and 14 mg tablets of teriflunomide. This news, revealed on Tuesday, 8th April 2025, is a major milestone for the Gujarat-based drug firm in increasing its footprint in the US market.

The approved teriflunomide tablets are used to treat patients with relapsing forms of multiple sclerosis. Concord Biotech said that this approval reflects its strength in successfully developing and commercialising a differentiated product pipeline for the US market.

Based on IQVIA™ data, the size of the market for teriflunomide tablets is around $402 million in the US and around $908 million worldwide. Concord Biotech emphasized that the size of the market for this tablet offers significant opportunities for growth in the US as well as the global market.

In terms of share performance, Concord Biotech shares closed at ₹1,596.55 per share on the NSE on Tuesday with a marginal fall of 0.92%. The news of USFDA approval, however, came after market hours. In the last week, the stock had moved fairly flat at 0.02%, whereas it has lost 5% on a month-to-date basis and a larger decline of 27.78% since the start of the year. The market capitalisation of the company was ₹16,667.98 crore as of 8th April on the NSE. Its 52-week high was at ₹2,664.00 on 20th September 2024, and its 52-week low was at ₹1,327.05 on 4th June 2024.

USFDA clearance for its teriflunomide tablets is a significant regulatory milestone for Concord Biotech, and it could unlock a major revenue opportunity in a large therapeutic market. Success of the firm in getting into the highly competitive US pharma market will be closely monitored by investors and industry experts alike.

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