TGTX

TG Therapeutics, Inc.

5.25
USD
14.88%
5.25
USD
14.88%
3.48 40.53
52 weeks
52 weeks

Mkt Cap 749.87M

Shares Out 142.83M

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TG Therapeutics Shares Slide Premarket on Ukoniq Setback >TGTX

Shares of TG Therapeutics Inc. tumbled more than 25% in premarket trading Monday after the biopharmaceutical company said it is pulling its Ukoniq lymphoma drug from the market amid a possible increased risk of death. The U.S. Food and Drug Administration, which previously granted accelerated approval to Ukoniq for certain adults with marginal zone lymphoma and follicular lymphoma, in February had said it was looking into the issue. TG Therapeutics also said it was ending its pursuit of FDA approval of the combination of Ukoniq and its investigational drug ublituximab. The New York company said the move comes after updated data from a Phase 3 study of the combination showed an increasing survival imbalance in favor of the control arm. The FDA in February had noted that those receiving the combination also experienced more serious adverse events than those in the control arm. Ukoniq is TG Therapeutics' sole commercial product and accounted for nearly all of its revenue last year. The FDA, in granting the accelerated approval of the drug last year, noted that continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials. TG Therapeutics on Friday said it expects the agency will withdraw the accelerated approval. In a research note on Friday, analysts Josh Schimmer and Maneka Mirchandaney at Evercore ISI said they had cut their target price on TG Therapeutics shares to $11 from $20 after removing the company's hematology franchise from their model. adding that they plan to reevaluate their stance on the stock after a conference call the company plans to hold later Monday morning. TG Therapeutics shares, which closed Thursday at $8.85, were recently down 26.6% to $6.50 in premarket trading. Write to Colin Kellaher at colin.kellaher@wsj.com

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