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TGTX

TG Therapeutics

$8.38

0.93 (12.48%)

08:42
04/01/19
04/01
08:42
04/01/19
08:42

TG Therapeutics reports data from MZL cohort of Phase 2b UNITY-NHL trial

TG Therapeutics reported interim data from the ongoing single-arm marginal zone lymphoma, or MZL, cohort of its Phase 2b clinical trial known as UNITY-NHL. The MZL cohort of UNITY-NHL is designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. Umbralisib is an investigational, oral, once daily PI3K delta inhibitor with unique inhibition of CK1 epsilon and is currently under development for the treatment of non-Hodgkin lymphoma, or NHL, and chronic lymphocytic leukemia, or CLL. The MZL cohort of UNITY-NHL enrolled patients with relapsed or refractory MZL who had received prior treatment with one or more lines of therapy including at least one anti-CD20 regimen. In August 2018, the trial completed enrollment with 69 treated patients. The interim data reported included safety and tolerability data on all 69 treated patients and efficacy data on 42 patients who were enrolled at least 9 cycles prior to the data cut-off date. The primary endpoint is overall response rate, or ORR, as assessed by IRC using criteria adopted from the International Working Group criteria for malignant lymphoma. Overall, there was 88% clinical benefit rate by IRC. All patients achieving a complete response by IRC remain on study and 86% of patients had a reduction in tumor burden The median time to initial response was 2.7 months. Interim safety data were presented for all 69 treated patients with a median duration of exposure of 6.9 months. No unexpected toxicities were observed. The most common adverse events were diarrhea, nausea and fatigue, with the majority of events grade 1 in severity. The most frequent grade 3 or higher adverse events were neutropenia, diarrhea and ALT/AST increase, observed in 13%, 10% and 10% of patients, respectively. A subgroup analysis of patients treated for greater than six cycles was also conducted to evaluate long-term incidence of key toxicities of interest occurring after six cycles of treatment. Median duration of treatment of this subgroup was 10.1 months. In this subgroup, grade 3 or higher adverse events of interest were rare, limited to two patients with diarrhea and one patient with pneumonitis, with no events of ALT/AST elevation, pneumonia or colitis.

  • 01

    Apr

TGTX TG Therapeutics
$8.38

0.93 (12.48%)

02/06/19
JEFF
02/06/19
INITIATION
Target $8
JEFF
Buy
TG Therapeutics assumed with a Buy at Jefferies
Jefferies analyst Chris Howerton assumed coverage of TG Therapeutics with a Buy rating and $8 price target. The analyst remains positive on the company's lead assets umbralisib and ublituximab.
03/05/19
RHCO
03/05/19
NO CHANGE
Target $15
RHCO
Buy
TG Therapeutics price target lowered to $15 from $24 at SunTrust
SunTrust analyst Peter Lawson lowered his price target on TG Therapeutics to $15, saying he has updated his model on the company's Marginal zone lymphoma readouts and the Follicular lymphoma data with new timing estimates for catalysts in those programs. The analyst also keeps his Buy rating on the shares longer term, saying he remains positive on TG Therapeutics' "capital-efficient strategy of utilizing therapeutics to develop novel combination therapies" and sees its proprietary doublet TG-1101 + TGR-1202 potentially serving patients across all lines of Chronic Lymphocytic Leukemia.
03/29/19
CANT
03/29/19
INITIATION
Target $17
CANT
Overweight
TG Therapeutics initiated with an Overweight at Cantor Fitzgerald
Cantor Fitzgerald analyst Alethia Young initiated TG Therapeutics with an Overweight and $17 price target.
03/29/19
CANT
03/29/19
INITIATION
Target $17
CANT
Overweight
Cantor starts TG Therapeutics with Overweight rating, $17 price target
Cantor Fitzgerald analyst Alethia Young initiated coverage of TG Therapeutics with an Overweight rating and $17 price target. The analyst believes umbralisib and ublituximab have attractive profiles in oncology and autoimmune B-cell diseases. Investors are cautious on the PI3K commercial potential and give no credit to multiple sclerosis due to the competitive yet price sensitive landscape, but both lead assets as clinically de-risked with proven targets, Young tells investors in a research note. She thinks the risk/reward on TG shares is positive.

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