What happened
After reporting early-stage trial results for one of the cancer drugs in its pipeline, TG Therapeutics (TGTX 1.06%) jumped 9.9% on Wednesday.
So what
The clinical-stage biotech stock has previously provided interesting trial data for TG-1101, or ublituximab, when used with AbbVie's (ABBV 0.98%) and Johnson & Johnson's (JNJ 0.29%) Imbruvica in leukemia patients. Today, it unveiled positive results from a trial evaluating another drug, umbralisib.
IMAGE SOURCE: GETTY IMAGES.
Specifically, umbralisib was clinically active with 85% of relapsed or refractory CLL patients achieving an objective response and 53% of patients with relapsed or refractory follicular lymphoma achieving an objective response, including two patients with a complete response.
The data could indicate that results expected later this year from a trial evaluating the use of umbralisib and ublituximab together in refractory CLL will succeed. The two-drug combination (U2) is being compared head-to-head against Gazyva and chlorambucil, a chemotherapy. If TG Therapeutics' doublet outperforms Gazyva, then TG Therapeutics' plan is to discuss the chances of approval with the Food and Drug Administration.
Now what
Ublituximab's overall response rate alongside Imbruvica is 81%, and if adding umbralisib to it can improve upon treatment, this could be a nine-figure opportunity for the company. For comparison, Imbruvica is a multibillion-dollar drug and Gazyva sales were about $300 million in 2017, at current exchange rates.
It's anyone's guess if final trial data that could support an FDA OK will be as good as we've seen so far and if the FDA will provide an easy pathway to market. Nevertheless, the data's good enough right now for me to think that this company might be worth more than its current $978 million market cap if trials go its way.
