Exelixis, Inc. (NASDAQ: EXEL) is off to a strong start in the pre-market hours this morning after announcing that it has completed the submission of a supplemental New Drug Application, also known as sNDA. As a result, investor excitement ensued, leading to gains in the stock and prompting our partners at Trade Ideas to alert us to the movement. At the moment (8:40), EXEL is trading at $27.80 per share after a gain of $0.89 per share or 3.31% thus far today.
EXEL Gains On sNDA News
As mentioned above, Exelixis is having an incredibly strong start to the trading session in the pre-market hours after announcing that it has completed the submission of a supplemental New Drug Application to the United States Food and Drug Administration. The sNDA surrounds CABOMETYX® tablets for the treatment of patients with previously untreated advanced renal cell carcinoma. The submission of the sNDA is the result of positive data from the CABOSUN randomized Phase 2 clinical trial of CABOMETYX in patients with previously untreated advanced RCC with intermediate- or poor-risk disease per the International Metastatic Renal Cell Carcinoma Database Consortium, or IMDC. In a statement, Michael M. Morrissey, Ph.D., President and CEO at EXEL, had the following to offer…
“All of us at Exelixis are focused on improving care and outcomes for patients with cancer. Having successfully launched CABOMETYX for patients with previously treated advanced RCC, the submission of this sNDA for CABOMETYX as a treatment in the first-line RCC setting represents an important milestone for us… If approved, CABOMETYX will offer an important new alternative for the treatment of patients with previously untreated advanced RCC, having demonstrated a clinically meaningful and statistically significant progression-free survival benefit over sunitinib, a current standard of care. We would like to sincerely thank the study patients and clinicians who participated in the CABOSUN trial, the Alliance and NCI-CTEP, as well as our dedicated clinical, medical and regulatory teams for bringing us one step closer to our goal of expanding the population of patients who may benefit from CABOMETYX.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on EXEL. In particular, we’re interested in finding out if this sNDA will be approved, which chances are high considering the overwhelmingly positive clinical data surrounding the treatment. Nonetheless, we’ll continue to follow the story and bring the news to you as it breaks!
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