Exelixis Inc. (EXEL) Shares See New Highs After FDA Grants Priority Review On New Drug Application


 
 
11:31 10/16/2017

A genomics-drug discovery company EXEL  announced that the U.S Food and Drug Administration (FDA) granted a priority review for the company’s drug CABOMETYX (cabozantinib). The FDA granted Priority Review and gave them a Prescription Drug User Fee Act (PDUFA) action date in February 15, 2018.

This new drug is for patients with previously untreated advanced renal cell carcinoma (RCC). The new sNDA (supplemental New Drug Application) is constructed on recorded results from CABOSUN, which is a randomized phase 2 trial with the National Cancer Institute’s Cancer Therapy Evaluation Program (NCI-CTEP).

If this sNDA application is approved by the FDA, it will allow a drug sponsor to make changes to a formerly permitted product label which include adjustments to the indication. In April 2016, FDA approved CABOMETYX for the treatment of patients with extreme RCC and who have received prior anti-angiogenic therapy.

Chief Medical Officer of Exelixis, Gisela Schwab said, “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 enw treatment options,” Schwab added.

The new application submitted to the FDA sent share prices of EXEL  through the roof. Shares were trading at mid $20 levels before the news and after the release, shares jumped 25% and hit $32 which is an all-time high for the company trading on the NASDAQ exchange.


This article has been provided by a Chasing Markets contributor. All content submitted by this author represent their personal opinions, and should be considered as such for entertainment purpose only. All opinions expressed are those of the writer, and may not necessarily represent fact, opinions, or bias of Chasing Markets.
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