TG Therapeutics' Shares Soar On Positive Early-Stage Data

Shares of TG Therapeutics, Inc. (NASDAQ:TGTX) rose 30.3% after it announced the positive first clinical data from its once-daily, oral, BTK inhibitor, TG-1701, as a single agent and as a triple therapy in combination with ublituximab (TG-1101), its novel glycoengineered anti-CD20 monoclonal antibody, and umbralisib (TGR-1202), its oral, dual inhibitor of PI3K delta and CK1 epsilon, in patients with relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

In the study, TG-1701 demonstrated superior selectivity for BTK compared to ibrutinib in an in vitro whole kinome screening. The data showed that the proprietary triplet of U2 plus TG-1701 induced 86% overall response rate(ORR) (6 of 7) among patients with relapsed/refractory NHL and CLL at the lowest dose of TG-1701 tested.

The study also showed that single-agent TG-1701 induced responses at multiple dose levels (including the lowest dose tested) across multiple B-cell diseases. The candidate demonstrated an encouraging safety profile to date, with dose escalation continuing for the combination with U2.

The company will continue the dose escalation of TG-1701 in the combination arm and identify the optimal dose for this therapy.

Shares of the company have skyrocketed 126.4% compared with the industry’s growth of 13.3%.

Separately, the company announced the triple therapy data from the phase I/II study of ublituximab in combination with venetoclax in patients with relapsed/refractory CLL. The data showed 100% ORR in relapsed/refractory CLL patients treated with U2 (umbralisib + ublituximab) plus venetoclax at cycle 7. The data also showed that 100% of patients (n=9) achieved undetectable minimal residual disease (MRD) in the peripheral blood after 12 months of therapy, and 78% achieved undetectable MRD in the bone marrow and stopped all therapy.

Data from both studies were presented at the 61^st American Society of Hematology (ASH) Annual Meeting and Exposition.

Zacks Rank & Stocks to Consider

TG Therapeutics currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the biotech sector are Alkermes Plc. (NASDAQ:ALKS) , Anika Therapeutics Inc. (NASDAQ:ANIK) and Innoviva Inc. (NASDAQ:INVA) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.

Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.

Innoviva’s earnings per share estimates have increased from $1.71 to $2.03 for 2019 and from $1.07 to $1.34 for 2020 in the past 60 days.

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