Exelixis Inc Stock Price, News & Analysis

Exelixis, Inc. (NASDAQ: EXEL) announced that its phase 3 CONTACT-03 study did not achieve its primary endpoint of progression-free survival (PFS) when evaluating cabozantinib (CABOMETYX^®) in combination with atezolizumab versus cabozantinib alone in patients with advanced renal cell carcinoma (RCC) post-immune checkpoint therapy. The trial included 522 patients but failed to show clinical benefit for the combination treatment. However, the safety profile remained consistent with known effects of individual agents, with no new safety signals observed. Detailed findings will be revealed in a forthcoming medical meeting.

Exelixis (NASDAQ: EXEL) is scheduled to participate in multiple investor conferences in March 2023. The company will present at the Cowen 43rd Annual Health Care Conference on March 7 at 1:30 PM ET in Boston, and at the Barclays Global Healthcare Conference on March 14 at 1:35 PM ET in Miami. Additionally, Exelixis will present virtually at the Oppenheimer 33rd Annual Healthcare Conference on March 14 at 1:20 PM ET. Investors can access the live webcasts and replays on the company’s website. Exelixis is committed to advancing cancer care through innovative therapies.

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.