TG Therapeutics stock sinks after Phase 3 test of leukemia treatment falters, but still has 5 key tests in the pipeline

TG Thereapeutics Inc (NASDAQ:TGTX) stock sank on Tuesday after a test called the Unity-CLL Phase 3 trial could not go ahead because the Data Safety Monitoring Board (DSMB) said the results were not sufficient to conduct an Overall Response Rate (ORR) analysis for the drug treating leukemia, although the company remains optimistic about the longer-term prospects for the drug’s approval.

In a statement, TG Therapeutics said that “given the uncertainty surrounding the timing and the outcome of the ORR analysis, as well as the significant regulatory hurdles associated with accelerated approval for CLL, the company is now guiding that it will focus on the primary endpoint of Progression Free Survival (PFS) to support full approval of the ublituximab plus umbralisib (U2) combination.”

“We could have a PFS read out in 2019, and we remain extremely optimistic about the prospects for a successful PFS result,” said TG Therapeutics CEO Michael Weiss, adding the Phase 3 trial continues to be conducted under the Special Protocol Assessment agreement with the US Food and Drug Administration.

An SPA is a declaration from the FDA that a pending Phase 3 trial’s design, clinical endpoints and statistical analysis are acceptable for eventual FDA approval.

The DSMB said that after reviewing of the data there were no safety concerns and recommended the trial continue without any modification.

Shares of TG Therapeutics dropped 37.3% to a 52-week low of $5.88 before paring some of the loss to trade 34.3% lower at $6.07.

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TG Therapeutics said it also still has several drugs under regulatory review.

“We now have 5 fully enrolled registration-directed programs, including UNITY-CLL, UNITY-NHL (including Follicular Lymphoma, Marginal Zone Lymphoma and Diffuse Large B-cell Lymphoma cohorts) and the ULTIMATE Phase 3 MS (multiple sclerosis) program and are awaiting pivotal data from all of them,” Weiss said. “We believe we remain well positioned to deliver significant value for our shareholders.”

The New York-based company is developing therapies targeting hematological malignancies and autoimmune diseases.

TG-1101 (ublituximab) is a glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202 (umbralisib), an orally available PI3K delta inhibitor for various hematologic malignancies.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.

Story by ProactiveInvestors