Exelixis (EXEL) Stock up +9 Percent on FDA Approval

Shares of Exelixis Inc. (EXEL) were up +0.39 or +8.37 percent in Tuesday’s premarket after the company announced that the FDA had approved the company’s lead cancer drug cabozanitinib, which will be marketed under the brand name CABOMETYX. Exelixis stock closed at $4.66 per share, up +0.25 or +5.67 percent in Monday’s regular trading session.

Founded in 1994, South San Francisco based Exelixis Inc. is a genomics based biopharmaceutical company focusing on the development and commercialization of small molecule therapies that potentially improve cancer treatments.
Exelixis owns the worldwide rights to cabozantinib, which received its initial regulatory approval in the United States in 2012. The drug is marketed under the trade name COMETRIQ. Regulators in the United States and Europe are currently reviewing the company’s application to use the treatment on patients with advanced renal cell carcinoma or RCC.

Exelixis announced that the FDA had given its approval for CABOMETYX, the company’s tablet form of cabozantinib for the treatment of patients with RCC who had received previous anti angiogenic therapy. According to Exelixis, RCC is the most widespread form of kidney cancer in adults.

According to data generated by the Phase 3 METEOR study, treating RCC with CABOMETYX led to a reduced rate of progression or death by 42 percent compared to treating the cancer with Novartis’ (NVS) Afinitor (everolimus). The median progression free survival rate for patients treated with cabozantinib was 7.4 months compared to 3.8 months for patients treated with everolimus.

In February, the company announced a significant increase in the overall survival rate of patients treated with CABOMETYX compared with everolimus. CABOMETYX was linked to a 34 percent reduction in death rates compared to everolimus, with a median survival rate of 21.4 months versus 16.5 months for patients treated with everolimus.

Exelixis stated in its press release that, “The efficacy profile demonstrated by CABOMETYX in the METEOR trial, now complemented by the overall survival benefit, is highly compelling. CABOMETYX is distinct from other approved treatment options, as it targets multiple tyrosine kinases involved in the development of RCC, including MET, AXL and three VEGF receptors. At the same time, physicians are very familiar with this class of drug and how to use dose adjustments to balance safety and efficacy. The approval of CABOMETYX is wonderful news for physicians who are looking for a new option for their previously treated patients with advanced kidney cancer.”

CABOMETYX was granted Fast Track and Breakthrough Therapy designations by the FDA and is the first treatment to demonstrate robust and clinically meaningful improvement in the three key efficiency parameters, objective response rate, progression free survival and overall survival. In late January, Exelixis received approval from the European Medicines Agency for cabozantinib as a treatment for patients with advanced RCC that had received one prior therapy.

On February 29th, 2016 Exelixis and Ipsen SA announced an exclusive licensing and commercialization agreement for developing cabozantinib indications outside the United States, Canada and Japan.  Exelixis shareholders and the market are showing their optimism in this morning’s premarket.

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Published on Apr 26, 2016
By Jay Hawk
Jay Hawk
Jay Hawk enjoyed a 12-year professional financial markets career incorporating extensive first hand futures and options experience obtained by trading in the stock, commodity and forex markets on U.S. exchanges. Since retiring as a full-time financial market professional, he has been actively trading stock, commodities, forex and options for his own account and managing funds for others, as well as writing financial market commentary and educational articles.

Copyrighted 2016. Content published with author's permission.

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