Exelixis Inc. reports developments from its oncology business, including commercial performance for the cabozantinib franchise and clinical and regulatory updates across cancer programs. The company discovers, develops and commercializes cancer medicines, with CABOMETYX® (cabozantinib) as its flagship commercial product and COMETRIQ® also part of its cabozantinib portfolio.
Recurring updates include quarterly financial results, product revenue trends, financial guidance, pipeline milestones and investor conference presentations. Exelixis also discusses zanzalintinib, an investigational oral kinase inhibitor, and a broader pipeline of small molecules and biotherapeutics targeting additional tumor types and indications.
Exelixis, Inc. (NASDAQ: EXEL) will release its fourth quarter and full year 2022 financial results on February 7, 2023, after market close. A conference call and webcast will follow at 5:00 p.m. ET to discuss the results and provide a business update. Investors can access the event online at www.exelixis.com or by phone. A replay will be available until February 9, 2023.
Exelixis is focused on oncology, developing innovative treatments and expanding its product portfolio, including the flagship CABOMETYX. The company continues to invest in research to improve cancer care.
Exelixis, Inc. (NASDAQ: EXEL) received a favorable ruling from the U.S. District Court for the District of Delaware in its ongoing litigation against MSN Laboratories, upholding the validity of its cabozantinib compound patent (U.S. 7,579,473). The court rejected MSN's challenge regarding this patent and confirmed that MSN's proposed generic product infringes it. However, the court found that MSN’s product does not infringe Exelixis' N-2 polymorph patent (U.S. 8,877,776), which expires in 2030. Exelixis plans to request that the effective date for any potential approval of MSN’s generic product be set for August 14, 2026. Additionally, Exelixis continues its separate litigation concerning other cabozantinib patents.
Exelixis reported its preliminary $1.4 billion in U.S. net product revenues for 2022, with $375 million in Q4 revenue. Looking ahead, the company set its 2023 revenue guidance between $1,575 million and $1,675 million. Key corporate priorities include advancing cabozantinib trials and expanding the zanzalintinib program. The company will present at the J.P. Morgan Healthcare Conference on January 9, 2023, to discuss these results and future plans.
Nuvig Therapeutics, a biopharma company focused on autoimmune diseases, appointed Julie Anne Smith as CEO and Board member. With over 20 years in the life sciences sector, she has previously led biotech firms through drug development. Pamela Conley transitions to Chief Scientific Officer, having co-founded the company. Smith's leadership comes as Nuvig's lead program progresses towards IND-enabling activities. Nuvig aims to develop novel therapies to restore immune function without broad immunosuppression.
Exelixis, Inc. (NASDAQ: EXEL) announced that CEO Michael M. Morrissey, Ph.D., will deliver a corporate overview at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 8:15 PM ET. Investors can access the webcast via www.exelixis.com, under the News & Events section. A replay will be available for 30 days post-event. Exelixis is dedicated to developing innovative cancer therapies, with a portfolio that includes four commercially available products and a commitment to advancing its pipeline.
Exelixis has initiated the STELLAR-304 trial, a phase 3 study evaluating zanzalintinib in combination with nivolumab against sunitinib in patients with advanced non-clear cell renal cell carcinoma (nccRCC). This pivotal trial aims to enroll approximately 291 patients with limited treatment options. The trial's primary objective is to assess progression-free survival and objective response rates. The combination's promise is supported by prior phase 1 data indicating zanzalintinib's efficacy in advanced kidney cancer. The partnership with Bristol Myers Squibb for nivolumab is noteworthy.
Exelixis announced that the CONTACT-01 study failed to meet its primary endpoint of overall survival in patients with metastatic non-small cell lung cancer. This phase 3 trial evaluated cabozantinib combined with atezolizumab against docetaxel in patients who previously progressed on other therapies. The safety profile of the combination was consistent with known effects, with no new safety signals reported. Detailed findings will be presented at a future medical meeting.
Exelixis, Inc. (NASDAQ: EXEL) released initial results from the QUARTZ-101 trial, evaluating XL102, a CDK7 inhibitor for advanced solid tumors. The trial shows XL102 was well tolerated across five dose levels with 26 patients treated. Most common cancer types included hormone receptor-positive breast cancer, pancreatic cancer, and sarcoma. Although no objective responses were observed, two patients showed stable disease. The ongoing study will assess the safety and efficacy of XL102, with further evaluations planned in combination therapies.
Exelixis, Inc. (Nasdaq: EXEL) will participate in a fireside chat at the JMP Securities Hematology and Oncology Summit on December 7, 2022, at 12:00 pm ET. Access the webcast at www.exelixis.com. A replay will be available for 30 days.
Exelixis focuses on oncology, offering products like CABOMETYX®, COMETRIQ®, and COTELLIC®. The company aims to develop new therapies for challenging cancers, leveraging its established drug discovery platform.
Exelixis (Nasdaq: EXEL) announced management's participation in several investor conferences in November. Key presentations include: Stifel Healthcare Conference in New York on November 16, Jefferies London Healthcare Conference also on November 16, and Piper Sandler's Healthcare Conference in New York on November 29. Additionally, Exelixis will present virtually at the Evercore ISI HealthCONx on November 29. Webcast access and replays will be available on www.exelixis.com.