Exelixis, Inc. (NASDAQ: EXEL)
Exelixis is having an incredibly strong day in the market today after reporting positive news from a key Phase 2 clinical trial. Today, we’ll talk about the data that was released, how the stock reacted to the news, and what we can expect to see from EXEL ahead.
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EXEL Reports Positive Phase 2 Trial Results
Today is shaping up to be a great day for Exelixis, and for good reason. The company reported its results from a trial known as CABOSUN. Through this randomized Phase 2 trial, the company evaluated cabozantinib as a treatment for patients with previously untreated advanced renal cell carcinoma. The patients in the study were also at intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium.
During the clinical trial, EXEL showed that cabozantinib demonstrated a clinically meaningful and statistically significant 31% reduction in rate of disease progression or death. During the study, it was shown that median progression-free survival rates came in at 8.2 months. This showed an incredible improvement in PFS over Sunitinib, which had a rate of 5.6 months. We also learned that objective response rates were significantly improved.
Along with the release of data, a key statement was made with regard to the EXEL trial by Toni K. Choueiri, M.D., Director at the Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, and Chair of the CABOSUN study. Here’s what Dr. Choueiri had to say:
“The results presented today support the potential of cabozantinib to become a new therapeutic option for previously untreated patients following their diagnosis with advanced kidney cancer… Not only has cabozantinib surpassed suntinib, the current standard of care, in progression-free survival and objective response rate, cabozantinib’s effects on progression-free survival were also consistently favorable across patient stratification subgroups including IMDC intermediate versus poor-risk groups and presence or absence of bone metastases.”
How The Stock Reacted To The News
When following biotech companies, we learn quickly that the news surrounding clinical trials is important. After all, a successful trial will generally lead to big gains while a failure will send the stock spiraling downward. In the case of Exelixis, the trial results were overwhelmingly positive. As a result, we saw strong gains in the morning hours. However, as I write, new news is breaking that is sending the stock down. Unfortunately, preliminary results in another trial are overwhelmingly concerning. Currently (12:15), EXEL is trading at $12.05 per share after a loss of $0.90 per share (6.95%) thus far today.
Breaking News: Preliminary Results In Another Trial Cause Concerns
As mentioned above, this article was going to be all about Cabozantinib. However, as I wrote, a new story started breaking. At the moment, the stock is taking a dive following preliminary results from another study. At the moment, EXEL is working with Bristol-Myers Squibb (BMY) in a joint Phase 1 trial of CaboNivo. The trial surrounds the drug’s use as a treatment for Urothelial and other genital cancers. Unfortunately, preliminary results showed that nine of the 24 patients required dose reductions due to adverse events. As a result, the gains seen early in the day quickly turned into losses.
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Where Do We Go From Here?
In my opinion, the sell off following preliminary phase 1 data is far overblown. At the end of the day, the idea is to define doses and show that the concept can come to fruition. Sometimes dose changes will happen. It is far too early in the study to know if it is a success or a failure. Nonetheless, I am overwhelmingly happy with Exelixis’ performance with Cabozantinib. The company showed that their treatment works better than the current standard of care. As a result, I’m expecting that we’re going to see a shift in how renal cell carcinoma is treated. All in all, for me, the positive news released today far outweighs the negative. As a result, I’m expecting to see a fast recovery and further gains from EXEL moving forward.
What Do You Think?
[Image Courtesy of Wikipedia]