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TICKERS: EXEL

Exelixis Shares Climb 21% on Positive Phase 3 Advanced Kidney Cancer Study Results

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Shares of Exelixis reached a new 52-week high price after the firm reported positive topline results from its Pivotal Phase 3 CheckMate -9ER trial evaluating Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib) in previously untreated advanced renal cell carcinoma.

Oncology-focused biotechnology company Exelixis Inc. (EXEL:NASDAQ) and global pharmaceutical firm Bristol-Myers Squibb Co. (BMY:NYSE) today announced that "CheckMate -9ER, a pivotal Phase 3 trial evaluating Opdivo® (nivolumab) in combination with CABOMETYX®(cabozantinib) compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC), met its primary endpoint of progression-free survival at final analysis, as well as the secondary endpoints of overall survival at a pre-specified interim analysis, and objective response rate."

Dr. Toni Choueiri, director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute and Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School, commented, "The results from the pivotal CheckMate -9ER trial clearly demonstrate the combination of cabozantinib plus nivolumab provides a clinically meaningful benefit in the key efficacy measures of progression-free survival and overall survival for previously untreated kidney cancer patients...If approved, this combination may become an important new first-line option for patients with metastatic renal cell carcinoma. We look forward to presenting detailed results at an upcoming congress."

Bristol Myers Squibb's development lead of genitourinary cancers, Brian Lamon, Ph.D., stated, "The positive topline results from the Phase 3 CheckMate -9ER trial evaluating Opdivo in combination with CABOMETYX build on our understanding of Opdivo-based regimens, and we look forward to working with global health authorities to help bring this new combination regimen to previously untreated patients, a population that despite recent advances, remains in need of additional therapeutic options that extend survival."

Gisela Schwab, M.D., Exelixis' president, product development and medical affairs and chief medical officer, remarked, "Given the growing body of data showing that CABOMETYX may create a more immune-permissive tumor environment that may enhance response to immune checkpoint inhibitors, we have been eagerly awaiting the results for the combination of cabozantinib and nivolumab in previously untreated renal cell carcinoma...We're delighted that the trial met its primary endpoint of progression-free survival as well as the secondary endpoints of overall survival and objective response rate, demonstrating consistent benefit for the combination in previously untreated renal cell carcinoma patients. We look forward to our continued collaboration with Bristol Myers Squibb as we work toward regulatory filings in the near future."

The firm noted that the CheckMate -9ER study is a randomized, multi-national Phase 3 trial evaluating patients with previously untreated advanced or metastatic renal cell carcinoma. The company reported that it intends to submit detailed CheckMate -9ER results in a presentation at an upcoming medical conference.

Opdivo® was defined by the firm as "a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response." Opdivo has already been approved by the FDA for several different indications and the company stated that it has become an important treatment option across multiple types of cancers. The release indicated that Opdivo is currently approved in more than 65 countries including the U.S., EU, Japan and China.

The company advised that CABOMETYX® tablets are approved in the U.S., EU, Japan and other countries for the treatment of patients with advanced renal cell carcinoma (RCC) and for the treatment of patients with HCC who have been previously treated with sorafenib. The company explained that RCC is the most common type of kidney cancer in adults, occurs approximately twice as much in men than women and accounts for greater that 140,000 yearly deaths worldwide.

Bristol Myers Squibb is a large global biopharmaceutical company headquartered in New York, N.Y., with a market cap of over $140 billion.

Exelixis Inc. is an oncology-focused biotechnology company based in Alameda, Calif., that is focused on developing commercializing new medicines for difficult-to-treat cancers. The company has developed four commercially available products, CABOMETYX® (cabozantinib), COMETRIQ® (cabozantinib), COTELLIC® (cobimetinib) and MINNEBRO® (esaxerenone). The firm has advised that it has entered into agreements with leading pharmaceutical companies to market these medicines to patients globally.

Exelixis has a market capitalization of around $5.98 billion with approximately 307.7 million shares outstanding and a short interest of about 5.8%. EXEL shares opened 18% higher today at $23.00 (+$3.56, +18.31%) over Friday's $19.44 closing price and reached a new 52-week high price this morning of $24.90. The stock has traded today between $22.49 and $24.90 per share and is currently trading at $23.54 (+$4.10, +21.09%).

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