Exelixis Inc Stock Price, News & Analysis

Exelixis, Inc. (NASDAQ: EXEL) mourns the loss of Gisela M. Schwab, M.D., Chief Medical Officer, who passed away after a medical leave since June 18, 2021. Her leadership and contributions significantly advanced the company’s clinical development efforts, transitioning Exelixis into a commercial biotechnology firm. The news follows the recent passing of Jon Berndt, Senior VP of Sales. Both were influential figures in the oncology field, leaving behind a legacy of dedication and impact on patient care.

Exelixis (Nasdaq: EXEL) announced participation in several virtual investor conferences in September 2021. The schedule includes:

• Morgan Stanley 19th Annual Global Healthcare Conference on September 9 at 1:15 PM EDT.
• H.C. Wainwright 23rd Annual Global Investment Conference available on-demand from September 13 at 7:00 AM EDT.
• BofA Securities Global Healthcare Conference on September 15 at 5:35 PM BST.
• Cantor 2021 Virtual Global Healthcare Conference on September 29 at 2:40 PM EDT.

Webcasts will be accessible via their website.

Exelixis announces that Takeda and Ono received approval from the Japanese Ministry of Health to market CABOMETYX in combination with OPDIVO for treating unresectable or metastatic renal cell carcinoma (RCC). This approval follows the success of the CheckMate -9ER trial, which showed that the combination significantly improved overall survival and doubled median progression-free survival compared to sunitinib. Exelixis is set to receive a $20 million milestone payment from Takeda upon the first commercial sale in Japan.

Exelixis (Nasdaq: EXEL) has expanded its collaboration with Invenra to include 20 additional oncology targets, enhancing their joint efforts to develop mono-specific and multi-specific antibodies for cancer treatment. Exelixis will pay Invenra an upfront fee of $15 million and additional fees for the new targets. The agreement allows Exelixis to own all antibody sequences discovered, with potential milestone payments for Invenra. This partnership aims to strengthen Exelixis' oncology pipeline and improve cancer therapy options for patients.

Exelixis reported impressive financial results for Q2 2021, with total revenues reaching $385.2 million, a 48% increase from Q2 2020. Net product revenues from CABOMETYX rose 59% year over year, driven by strong adoption of the CABOMETYX and OPDIVO combination therapy for renal cell carcinoma. The company has raised its revenue guidance for 2021, projecting total revenues between $1.3 billion and $1.4 billion. Key milestones include a supplemental NDA filing for cabozantinib in thyroid cancer and promising results from clinical trials.

Exelixis (NASDAQ: EXEL) announced the FDA's acceptance of its supplemental New Drug Application (sNDA) for CABOMETYX^® (cabozantinib) to treat patients aged 12 and older with radioactive iodine-refractory differentiated thyroid cancer. The FDA has granted Priority Review, with a PDUFA target action date of December 4, 2021. The sNDA is based on promising results from the COSMIC-311 pivotal trial that indicated significant progression-free survival benefits. This development could position CABOMETYX as a critical treatment option for patients lacking standard care.

Exelixis, Inc. (Nasdaq: EXEL) will release its second quarter 2021 financial results on August 5, 2021, post-market close. A conference call is scheduled at 5:00 p.m. EDT to discuss the results and provide a business update. Access to the call will be available on their website and via phone. Exelixis focuses on oncology and has developed four commercial products, including CABOMETYX and COTELLIC, with ongoing partnerships to advance cancer therapies.

Exelixis, Inc. (Nasdaq: EXEL) announced that Dr. Peter Lamb, its Executive VP and Chief Scientific Officer, will present at the William Blair Biotech Focus Conference on July 15, 2021, at 2:00 p.m. EDT. Interested participants can access the webcast via www.exelixis.com and should connect 15 minutes early. A replay will be available for 14 days. Founded in 1994, Exelixis focuses on oncology and has developed four commercial products, including CABOMETYX and COMETRIQ, while also collaborating with leading pharmaceutical companies.

Exelixis and Ipsen announced the positive results of their pivotal phase 3 COSMIC-312 trial, evaluating cabozantinib with atezolizumab in advanced hepatocellular carcinoma (HCC) patients. The trial met its primary endpoint, showing a 37% reduction in disease progression or death with cabozantinib compared to sorafenib (P=0.0012). However, the secondary endpoint of overall survival did not reach statistical significance, with Exelixis anticipating low probability of achieving this at final analysis, expected in early 2022. The results will inform potential regulatory filing with the FDA.