TG Therapeutics Inc (NASDAQ: TGTX) is climbing in the market this morning, and for good reason. The company announced positive data from a Phase 2b clinical trial.
As you could imagine, the news led to excitement among investors, pushing the stock on a run for the top. Today, we’ll talk about:
- The clinical data;
- what we’re seeing from TGTX stock as a result; and
- what we’ll be watching for ahead.
TGTX Announces Positive Clinical Results
As mentioned above, TG Therapeutics is having an incredibly strong start to the trading session this morning after announcing positive clinical data. The data came from a Phase 2b pivotal clinical trial evaluating umbralisib (TGR-1202) as an option for the treatment of cancer.
In the release, the company said that the Marginal Zone Lymphoma, or MZL, cohort of the UNITY-NHL trial met its primary endpoint. The primary endpoint is the improvement of Overall REsponse Rate. In the release, TGTX said that the results met its targeted guidance of 40%-50%.
The company said that it plans on discussing the results with the FDA regarding the potential filing of a New Drug Application for accelerated approval under the Breakthrough Therapy Designation.
In a statement, Michael S. Weiss, Chairman and CEO at TGTX, had the following to offer:
We are extremely pleased to announce that the UNITY-NHL marginal zone lymphoma cohort evaluating umbralisib monotherapy met the primary endpoint of ORR. While this was an early look at the response data, we were excited to have already met the target ORR, which we previously stated was approximately 40%-50%. Importantly, with many patients still on study, we anticipate the ORR will continue to improve with additional follow-up, which will also provide us with critical information on duration of response, progression free survival and long-term safety and tolerability necessary to support an NDA filing.
There are no fully approved drugs for MZL, and thus remains an unmet medical need and we are excited by the potential to offer a novel treatment for this underserved population. We look forward to discussing the results with the FDA as soon as possible and if all goes well, we believe we could be in a position to file for accelerated approval for umbralisib by year-end.
What We’re Seeing From The Stock
As investors, one of the first lessons that we learn is that the news moves the market. In the case of TG Therapeutics, the news proved to be overwhelmingly positive.
Not only did the company produce positive clinical data, the targeted indication has no fully approved therapies. Therefore an approval in this space would be a big win.
Considering this, it comes as no surprise to see that investors are excitedly pushing the stock for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:47), TGTX is trading at $6.12 per share after a gain of $0.93 per share or 17.92% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on TGTX. In particular, we’re interested in following the story surrounding the company’s continued work to bring TGT-1202 to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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