Global Blood Therapeutics Inc (NASDAQ: GBT) is flying in the market today, and for good reason. The company announced updated safety and efficacy results from a Phase 3 clinical trial. Of course, the news excited investors, sending the stock screaming for the top. Today, we’ll talk about:
- The clinical data;
- what we’re seeing from GBT as a result; and
- what we’ll be watching for ahead.
GBT Announces Positive Clinical Data
As mentioned above, Global Blood Therapeutics is having an incredibly strong start to the trading session this morning after the company announced updated efficacy and safety results from a clinical trial. The data came from Part A of its Phase 3 HOPE study. During the study, the company is assessing the safety and efficacy of voxelotor in patients ages 12 and older with sickle cell disease.
In the release, GBT said that preliminary results from 154 adolescents and adults with SCD are promising. The patients, treated with voxelotor for 24 weeks, demonstrated rapid, robust and sustained improvements in hemoglobin levels and measures of hemolysis. The drug also came with a favorable safety and tolerability profile. The company said that it will be presenting the data in an oral session today at the 60th American Society of Hematology Annual Meeting & Exposition.
In a statement, Elliott Vichinsky, M.D., lead investigator of the HOPE study, had the following to offer:
These longer-term efficacy and safety data from more than 150 patients enrolled in the HOPE Study continue to support the potential of voxelotor to be a disease-modifying treatment for SCD. These major improvements in anemia and hemolysis have the potential to prevent the chronic organ damage that is the leading cause of death in patients with SCD in the United States… In addition to the large improvements in hemolytic anemia, I am greatly encouraged in seeing a very good safety profile.
The above statement was followed up by Ted W. Love, M.D., President and CEO at GBT. Here’s what he had to say:
These data from the Phase 3 HOPE Study, including the clinically meaningful and statistically significant increase in hemoglobin, have been a key element in the discussions with the FDA which led to the agency’s agreement with GBT’s proposal for voxelotor under the subpart H accelerated approval pathway… To further support our NDA submission, we are continuing to generate efficacy and safety data on an additional 118 patients in the HOPE Study.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that the news leads to moves. In the case of Global Blood Therapeutics, the news proved to be overwhelmingly positive. After all, the strong data from the Phase 3 trial will likely help to support an NDA submission with the FDA relatively soon. So, it’s not surprising that excited investors are sending the stock on a run for the top in the market today. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (11:00), GBT is trading at $42.95 per share after a gain of $11.41 per share or 36.18% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the iWatch Markets team will continue to keep a close eye on GBT. In particular, we’re interested in following the continued development of voxelotor as the results from the Phase 3 trial are promising. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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