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Here's Why Exelixis Is Trading Higher By 20%

Here's Why Exelixis Is Trading Higher By 20%
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Exelixis Does It Again (Seeking Alpha)

Shares of Exelixis, Inc. (NASDAQ: EXEL) were trading higher by 20 percent early Monday morning after the company announced an encouraging update for its CABOMETYX (cabozantinib) therapy for the treatment of patients with advanced hepatocellular carcinoma.

The U.S. Food and Drug Administration has determined that Exelixis' supplemental New Drug Application for Cabometyx to treat patients suffering from renal cell carcinoma is now considered sufficiently complete to permit a substantive review, the company said in a press release.

The SnDA is based on data from the company's phase 2 trial called CABOSUN.

A priority review by the FDA has been granted with an assigned Prescription Drug User Fee Act action date set for Feb. 15, 2018.

Exelixis separately announced that a global phase 3 trial called CELESTIAL met its primary endpoint of overall survival with cabozantinib providing a statistically significant and clinically meaningful improvement in median OS compared to placebo in patients with advanced hepatocellular carcinoma.

The company plans on discussing the trial results with the regulatory authorities to determine the appropriate next step for the trial, including offering patients that were receiving a placebo to cross over to cabozantinib.

"We are excited that these positive results from the phase 3 CELESTIAL trial bring us one step closer to the potential of offering previously treated patients with this aggressive form of advanced liver cancer a much-needed new treatment option," said Gisela Schwab, M.D., president, product development and medical affairs and chief medical officer, Exelixis. "This is an important milestone for the cabozantinib development program; we are committed to studying cabozantinib in a range of tumor types as part of our mission to deliver medicines that improve treatment outcomes and give patients hope for the future."

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Posted-In: Cabozantinib FDA PharmaceuticalBiotech News FDA Movers General Best of Benzinga


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