Spark Therapeutics Inc (NASDAQ: ONCE) is having an overwhelmingly rough start to the trading session this morning, and for good reason. The company announced a business update, and part of that update had to do with a Phase 1/2 clinical trial. Unfortunately, the trial led to safety concerns that are causing investors to dump the stock, sending it down dramatically. Today, we’ll talk about:
- The safety concerns;
- what we’re seeing from ONCE stock as a result; and
- what we’ll be watching for ahead.
ONCE Falls On Safety Concerns
As mentioned above, Spark Therapeutics is having a rough start to the trading session in the pre-market hours this morning after announcing news with regard to a clinical program. In a press release issued after-hours yesterday, the company announced that two patients in its hemophilia phase 1/2 trial had a concerning immune response to the treatment. In fact, one of the patients was hospitalized as a result of the immune respones.
During the clinical trial, ONCE is assessing its gene therapy, knonw as SPK-9001 in patients with hemophilia B. In the release, the company said that 12 patients have been dosed so far. However, two of these patients who did experience an immune response, saw a drop in clotting factor levels. As a result, these patients had to be given on-demand treatment. Unfortunately, ONCE said that one of the patients did not respond rapidly to oral steroids. As a result, the patient had to receive intraveneous infusions in the hospital. This is ultimately considered to be a serious safety issue and could hinder the development and approval of SPK-9001. Also, during the trial thus far, 7 out of the 12 patietns required a course of oral steroids as a result of various symptoms.
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 Spark Therapeutics, the news proved to be overwhelmingly negative. After all, if a treatment is deemed to be unsafe, approval is not going to happen. Unforutnately for the company, the data thus far brings up some serious safety concerns. So, it’s no surprise that upset investors are sending the stock tumbling down. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (8:54), ONCE is trading at $54.00 per share after a loss of $23.61 per share or 30.42% 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 ONCE. In particular, we’re interested in following the story surrounding the company’s continued work to bring SPK-9001 to market. While there are some safety concerns, the company still plans on moving forward with a Phase 3 trial relatively soon. Nonetheless, we’ll continue to follow the story closley and bring the news to you as it breaks!
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