Welcome to our dedicated page for Exelixis news (Ticker: EXEL), a resource for investors and traders seeking the latest updates and insights on Exelixis stock.
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.
Bristol Myers Squibb (NYSE: BMY) and Exelixis (NASDAQ: EXEL) announced three-year follow-up results from the Phase 3 CheckMate -9ER trial, demonstrating significant benefits for the combination of Opdivo® (nivolumab) and CABOMETYX® (cabozantinib) in treating advanced renal cell carcinoma (RCC). With a median follow-up of 44 months, the combination showed a 30% reduction in the risk of death and improved overall survival (49.5 months vs. 35.5 months) compared to sunitinib. Progression-free survival also doubled (16.6 months vs. 8.4 months) while maintaining safety profiles. These results will be presented at the ASCO GU 2023 Symposium.
Exelixis has received FDA clearance for the Investigational New Drug (IND) application of ADU-1805, a monoclonal antibody targeting SIRPα, which is designed to block the SIRPα-CD47 checkpoint in patients with advanced solid tumors. This advancement signifies a critical step in Exelixis’ pipeline, with a phase 1 study set to begin in Q2 2023. The IND clearance activates a $35 million milestone payment to Sairopa. ADU-1805 shows promise due to its potential to treat a wider patient population than existing therapies. This move aligns with Exelixis' broader goal of innovating treatments for cancer patients.
Exelixis reported total revenues of $423.9 million for Q4 2022 and $1.61 billion for the full year, showing a rise in U.S. net product revenues for cabozantinib to $1.4 billion. GAAP EPS was $(0.09) for Q4 2022 but $0.56 for the full year. The non-GAAP EPS was $(0.03) in Q4 2022 compared to $0.82 for the full year. Research and development expenses rose to $336.8 million for Q4 and $891.8 million for the year. Exelixis aims for robust growth in 2023, targeting total revenues of $1.775-$1.875 billion. Upcoming milestones include pivotal trial data readouts and the advancement of its drug pipeline.
Exelixis, Inc. (NASDAQ: EXEL) has announced its participation in two major investor conferences in February 2023. The first is the Guggenheim Healthcare Talks Oncology Day, taking place on February 9 at 11:20 am ET in New York. The second conference is the SVB Securities Global Biopharma Conference, with a virtual presentation scheduled for February 15 at 2:20 pm ET.
Investors can access the webcasts via www.exelixis.com. Replays will be available for 30 days after the event. Exelixis focuses on innovative cancer treatments and aims to bring hope to patients through advanced therapies.
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.