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Watchlist Update: 1-16-2020 - TGTX - TG Therapeutics - Drug Update

$TGTX - On our trading list. Announced more progress with their drug pipeline. This one has done very well recently and has much more to go.


TG Therapeutics announced that the Company has initiated a rolling submission of a New Drug Application to the U.S. Food and Drug Administration requesting accelerated approval of umbralisib, the Company's oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with previously treated marginal zone lymphoma and follicular lymphoma.

The Company has received guidance from the FDA that submission of a single NDA for both the MZL and FL indications is acceptable. Umbralisib has previously been granted both orphan drug designation and breakthrough therapy designation by the FDA for MZL. The Company expects to complete the NDA rolling submission in the first half of 2020.


$TGTX, TG Therapeutics, Inc. / H1


Disclosure: I may trade in the ticker symbols mentioned, both long or short. My articles represent my personal opinion and analysis and should not be taken as investment advice. Readers should do their own research before making decisions to buy or sell securities. Trading and investing include risks, including loss of principal.

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