Tandem Diabetes Care Inc (NASDAQ: TNDM) is having an overwhelmingly strong start to the trading session this morning after the company announced that it has received approval from the FDA. Of course, the news excited investors, leading to big gains. Today, we’ll talk about:
- The approval;
- what we’re seeing from TNDM; and
- what we’ll be watching for ahead.
TNDM Announces FDA Approval
As mentioned above, Tandem Diabetes Care is having an incredibly strong start to the trading session this morning after announcing FDA approval. In a press release issued early this morning, the comapny announced that the United States Food and Drug Administration (FDA) has approved the t:slim X2™ Insulin Pump with Basal-IQ™ technology. This technology is a predictive low glucose suspend (PLGS) that is designed to help reduce the frequency and duration of low glucose events.
In the release, TNDM said that the t:slim X2 is the first and only automated insulin delivery system approved for children that are as young as six years old as well as the first insulin pump designated as compatible with integrated continuous glucose monitoring devices. In the release, the company said that it plans to launch the new product with Dexcom G6® continuous glucose monitoring integration, requiring no fingersticks for calibroation or diabetes treatment decisions. In a statement, Dr. Greg Forlenza, Assistant Professor of Pediatrics at the Barbara Davis Center and one of the principal investigotrs on the PROLOG trial by TNDM, had the following to offer:
Hypoglycemia can be a significant source of fear for people who use insulin and is a major cause of hospitalizations for people with diabetes… Basal-IQ technology proved very effective in the clinical trial at reducing time spent in hypoglycemia and improving time in range. The system was also simple to learn and use, so the training burden was minimal for the clinics and study participants compared to other automated insulin delivery systems.
The above statement was followed up by Kim Blickenstaff, President and CEO at TNDM, here’s what she had to offer:
The t:slim X2 Pump with Basal-IQ technology was designed to predict and help prevent time spent low using best-in-class CGM technology… As the first company to launch a touchscreen insulin pump capable of remote feature updates, and now the first to have a pump approved with iCGM compatibility, we are delivering new innovation to our customers at a pace that is unprecedented in our industry, furthering our mission to help improve the lives of people with diabetes.
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 Tandem Diabetes Care, the news proved to be overwhelmingly positive. After all, FDA approval means that the company now has the regulatory approval to start commercializing the insulin pump, leading to potential revenue. So, it’s no surprise that excited investors are sending the stock screaming for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (7:36), TNDM is trading at $24.72 per share after a gain of $4.41 per share or 21.71% 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 TNDM. In particular, we’re interested in following the story surrounding the commercialization efforts following the announcement of the FDA approval. Nonetheless, we’ll keep a close eye on the news and bring it to you as it breaks!
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