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TGTX

TG Therapeutics

$6.05

0.15 (2.54%)

08:49
11/22/16
11/22
08:49
11/22/16
08:49

TG Therapeutics says DSMB recommends continuation of UNITY-CLL Phase 3 trial

TG Therapeutics announced that the independent Data Safety Monitoring Board, or DSMB, providing oversight for the UNITY-CLL Phase 3 trial reviewed the cumulative safety data from the ongoing clinical study and informed the company that it has identified no safety concerns, and recommended the continuation of the study with no modifications. Per the protocol's pre-specified DSMB charter, the DSMB is scheduled to meet approximately every 6-9 months to review cumulative safety data. "We are encouraged by the positive outcome of the first DSMB safety review, especially since over two-thirds of the patients currently enrolled in the study are treatment naive CLL patients. Many may recall, as reported by Dr. Jennifer Brown at last year's ASH meeting, and published earlier this year in Blood, that idelalisib in treatment naive CLL patients was observed to cause rapid (most within less than5 weeks) and profound (Grade 3/4) liver toxicity in approximately 50% of the patients treated. Given those findings, we are pleased to report that the DSMB did not find any safety concerns and recommended the study continue without modification. We are also excited to report that the UNITY-CLL study continues to enroll well and we are still targeting completion of enrollment in the first half of 2018," stated Executive Chairman and Interim CEO Michael Weiss.

  • 03

    Dec

TGTX TG Therapeutics
$6.05

0.15 (2.54%)

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.
10/13/16
ROTH
10/13/16
NO CHANGE
Target $33
ROTH
Buy
Roth Capital remains a buyer of TG Therapeutics after GENUINE announcement
After TG Therapeutics announced that it amended the Phase 3 GENUINE study to have overall response rate as the primary endpoint, Roth Capital analyst Joseph Pantginis says the company is making the hard but right decision. While perceptions are negative on trial amendments, the analyst believes this clarity on timelines, the robustness of Phase 2 data and important drug approval precedents continue to point to a positive outcome for the study. Pantginis believes TG Therapeutics' shares are being oversold, and reiterates a Buy rating and $33 price target on the stock. In late morning trading, shares of TG Therapeutics have dropped more than 14% to $7.07.
10/14/16
HCWC
10/14/16
NO CHANGE
Target $18
HCWC
Buy
TG Therapeutics study changes should be no surprise, says H.C. Wainwright
In a research note titled "The Best Way to Pull Off a Band Aid Is Quickly," H.C. Wainwright analyst Andrew Fein says the changes TG Therapeutics announced yesterday to the GENUINE study were "necessary, timely, and, generally, should have not been a surprise" based on the last two quarterly updates. The protocol changes effectively dissolve the Special Protocol Agreement covering the study, which does increase the perceived regulatory risk even upon a study win, Fein tells investors in a research note. He lowered his price target for TG shares to $18 from $22 and keeps a Buy rating on the name. The analyst notes that removing the GENUINE program from his valuation would lead to a $16 price target.

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