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TGTX

TG Therapeutics

$8.25

-0.64 (-7.20%)

07:18
10/13/16
10/13
07:18
10/13/16
07:18

TG Therapeutics amends GENUINE Phase 3 trial

TG Therapeutics announced that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial. Prior to the amendments, the GENUINE study consisted of two parts: Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate, or ORR, in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; and Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival, or PFS, in all study patients, to support a filing for full approval of TG-1101. The amended protocol contains the following substantive changes: Part II of the study has been eliminated, and accordingly, the study's sole primary endpoint will be ORR as originally contemplated in Part I; and Target enrollment has been reduced to approximately 120 randomized patients. At the new study size, the study is 90% powered to show a statistically significant improvement in ORR, with the minimal detectable difference of approximately 20%. Additionally, patients will be followed until progression, but the study will no longer be powered for PFS.

  • 13

    Oct

TGTX TG Therapeutics
$8.25

-0.64 (-7.20%)

12/07/15
ROTH
12/07/15
NO CHANGE
Target $33
ROTH
Buy
TG Therapeutics gave 'strong' update at ASH, says Roth Capital
Roth Capital analyst Joseph Pantginis said TG Therapeutics' update at the ASH meeting was "strong" and that he continues to be impressed by both the efficacy and safety profile of the company's two lead drugs. The analyst keeps a Buy rating and $33 price target on the stock, which is a Focus Pick of the firm.
04/18/16
ROTH
04/18/16
NO CHANGE
Target $33
ROTH
Buy
TG Therapeutics remains Focus Pick at Roth Capital
Roth Capital analyst Joseph Pantginis says TG Therapeutics (TGTX) remains a Focus Pick, and reiterates a Buy rating and $33 price target on the company's shares. The analyst believes the accumulated data set and late stage aspect of the platform has de-risked the outcomes of the Phase 3studies for TG Therapeutics' TG-1101 and TGR-1202. Besides TG Therapeutics, Strongbridge (SBBP), Ligand (LGND), Concert (CNCE) and Cerulean (CERU) also fit into the "de-risked" category in the healthcare universe, Pantginis tells investors in a research note.
05/27/16
RHCO
05/27/16
INITIATION
Target $18
RHCO
Buy
TG Therapeutics initiated with a Buy at SunTrust
SunTrust analyst Yatin Suneja initiated TG Therapeutics with a Buy rating and $18 price target.
10/06/16
BMUR
10/06/16
INITIATION
Target $28
BMUR
Buy
TG Therapeutics assumed coverage with a Buy at Brean Capital
Brean Capital analyst Jason Wittes assumed coverage on TG Therapeutics with a Buy and $28 price target.

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