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TG Therapeutics Wins US FDA Accelerated Ok of Ukoniq, Says US Commercial Launch Now Underway -- Shares Climb

· 02/05/2021 09:41

02:41 PM EST, 02/05/2021 (MT Newswires) -- TG Therapeutics (TGTX) said Friday that the US commercial launch of Ukoniq is underway after the medicine won the US Food and Drug Administration's accelerated approval for two indications.

These indications include the treatment of relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20 based regimen, and the treatment of relapsed or refractory follicular lymphoma who have received at least three prior lines of therapy, the company said.

These indications were approved under accelerated approval based on overall response, TG Therapeutics said, adding that continued approval for those indications may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Shares of TG Therapeutics climbed more than 11% on the news.

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