Exelixis, Inc.’s (EXEL) RCC Treatment Gets Early FDA Approval

Exelixis, Inc. (NASDAQ:EXEL) said on Tuesday that the FDA approved its CABOMETYX tablets, for the expanded indication of patients with advanced renal cell carcinoma (RCC), two months ahead of the expected date.

Exelixis CEO commented, “Today’s approval of CABOMETYX is a true win for patients in the U.S. with advanced renal cell carcinoma who now have a new first-line treatment option […] We are very pleased with the expanded indication and are prepared to bring CABOMETYX to all eligible patients who may benefit from this important treatment option starting today. I would like to sincerely thank the 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 their tireless efforts to this end. We would also like to acknowledge the review team at FDA for their expeditious review of our application.”

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Principal investigator Dr. Toni Choueiri noted, “The CABOSUN trial enrolled treatment-naïve patients with advanced kidney cancer, including those who are known to fare poorly, such as patients with intermediate- or poor-prognostic factors and those with bone metastases or multiple sites of metastatic disease […] Physicians are already experienced in using CABOMETYX in the second-line advanced RCC setting, and it is a much-needed advance to also now have CABOMETYX as an option for their patients with previously untreated advanced RCC.”

“We at the Alliance for Clinical Trials in Oncology are very gratified that the CABOSUN study supported the approval of CABOMETYX for the potential first-line treatment of all patients with advanced renal cell carcinoma. This trial exemplifies how NCI-sponsored studies can be efficient, accrue rapidly, and yield results highly relevant to the field,” said Michael J. Morris, M.D., medical oncologist at Memorial Sloan Kettering Cancer Center, and Chair of the Alliance Genitourinary (GU) Committee.

Shares of Exelixis are currently trading at $26.81, up $0.74 or 2.84%. EXEL has a 1-year high of $32.50 and a 1-year low of $14.22. The stock’s 50-day moving average is $26.22 and its 200-day moving average is $25.68.

On the ratings front, Exelixis stock has been the subject of a number of recent research reports. In a report issued on November 1, Oppenheimer analyst Leah R. Cann assigned a Hold rating on EXEL. On the other hand, on October 16, Piper Jaffray’s Edward Tenthoff reiterated a Buy rating on the stock and has a price target of $33.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Leah R. Cann and Edward Tenthoff have a yearly average return of 0.1% and 7.1% respectively. Cann has a success rate of 42% and is ranked #3170 out of 4727 analysts, while Tenthoff has a success rate of 42% and is ranked #934.

Overall, one research analyst has assigned a Hold rating and 5 research analysts have issued a Buy rating on the stock. When considering if perhaps the stock is under or overvalued, the average price target is $35 which is 34% above where the stock opened today.

Exelixis is a biopharmaceutical company. It engages in the developing and commercializing small molecule therapies for the treatment of cancer. The company brands include comertriq and cobimetinib. Its pipeline consists of cabozantinib, cobimetinib and Xl 888.


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