Exelixis, Inc. (NASDAQ: EXEL) is having an overwhelmingly strong start to the trading session this morning, and for good reason. The company announced that the FDA has granted Priority Review surrounding one of the company’s pipeline treatments. Of course, this led to excitement among investors, sending the stock screaming for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (10:36), EXEL is trading at $31.62 per share after a gain of $6.86 per share or 27.69% thus far today.
EXEL Gains Big On FDA News
As mentioned above, Exelixis is having an incredibly strong start to the trading session this morning after announcing news it has received from the FDA. The company informed investors that the FDA has determined that the supplemental New Drug Application, also known as sNDA, for CABOMETYX® is sufficiently complete to permit a substantive review. On top of that, the FDA has granted Priority Review of the filing, assigning a PDUFA action date of February 15, 2018. In a statement, Gisela Schwab, M.D., President of Product Development and Medical Affairs, and Chief Medical Officer at EXEL, had the following to offer:
“The acceptance of the sNDA filing with a Priority Review is an important regulatory milestone for CABOMETYX and for our mission to improve treatment outcomes for patients with cancer… We look forward to working with the FDA as they review the application in our effort to offer CABOMETYX to patients with previously untreated metastatic RCC who are in need of new treatment options.”
The supplemental New Drug Application submitted by EXEL is based on data from the randomized Phase 2 clinical trial known as CABOSUN. The trial was conducted by The Alliance for Clinical Trials in Oncology as part of the company’s collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program.
If the sNDA is approved by the FDA, it will allow EXEL to make changes to the previously approved product label for CABOMETYX. In particular, the label changes the company is looking for is modifications to the indication the treatment has been approved for. On April 25, 2016, CABOMETYX ?was approved by the FDA for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. This approval was based on data gathered from the Phase 3 METEOR trial, demonstrating that CABOMETYX provided a statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate when compared to everolimus in the patient population.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on EXEL. In particular, we’re interested in following the news surrounding the sNDA and excited for the decision that will come on or before February 15th of next year. Considering the overwhelmingly positive data surrounding CABOMETYX, it only makes sense that the new labeling will be approved. However, it’s not set in stone until the FDA puts their stamp on it. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!