TG Therapeutics Inc (NASDAQ: TGTX) is making a run for the top in the market this morning, and for good reason. The company released interim data from a Phase 2b clinical trial. As you could imagine, the news was positive, exciting investors and sending the stock on a run for the top. Today, we’ll talk about:
- The interim data release;
- what we’re seeing from TGTX stock as a result; and
- what we’ll be watching for ahead.
TGTX Announces Positive Interim Data
As mentioned above, TG Therapeutics is having a great day in the market today after reporting positive interim clinical data. The data came by way of press release early this morning.
In the press release, TGTX provided data from an ongoing single-arm marginal zone lymphoma cohort of its Phase 2b clinical trial. The trial is known as UNITY-NHL.
According to the release, the MZL cohort of the trial was designed to investigate umbralisib as a single agent in patients with relapsed or refractory MZL. The treatment is an oral, once daily PI3K delta inhibitro with unique inhibition of CK1 epsilon. It is currently under development for the treatment of non-hodgkin lymphoma and chronic lyphocytic leukemia.
The data was provided during the morning’s official 2019 Press Program at the American Association of Cancer Research Annual Meeting. Later this afternoon, the data will be presented in an oral session.
In the release, TGTX said that the treatment led to a 52% Overall Response Rate, a 19% Complete Response Rate, and a 33% Partial Response Rate to date. Moreover, interim safety and tolerability data proved to be promising, with few high-grade adverse events.
It’s also worth mentioning that no events of colitis were reported. Also only 1 event of Grade 3 pneumonitis was preported and Grade 3 infections were limited, only occuring in 3 out of more than 60 patients.
In a statement, Michael S. Weiss, Executive Chairman and CEO at TGTX, had the following to offer:
We are very excited about these interim data and believe the results today demonstrate the activity and differentiated safety and tolerability profile of umbralisib at our Phase 3 dose of 800 mg once per day.
As announced previously, the efficacy for the entire population has already reached our target range of 40-50% ORR and we look forward to presenting the final data from the entire MZL cohort later this year when all patients have had the opportunity to be followed for at least 9 cycles. In addition, we look forward to discussing the results with the FDA with a goal of filing for accelerated approval by year end.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dive into the market is that the news leads to moves. When it comes to TG Therapeutics, the news proved to be overwhelmingly positive.
After all, this strong interim data shows that the company is progressing in the right direction when it comes to the development of this potentially high-value treatment. So, it’s not surprising to see that excited investors are pushing the stock on a run for the top.
As is just about always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:17), TGTX is trading at $9.01 per share after a gain of $0.97 per share or 12.06% 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 umbralisib through development and to patients in need. Nonetheless, we’ll keep a close eye on the story and bring the news to you as it breaks!
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