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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 host an investor briefing on February 13, 2021, at 5:30 p.m. EST to discuss data from the ASCO GU 2021 symposium. The focus will be on cabozantinib clinical data, including results from the CheckMate -9ER trial, evaluating CABOMETYX in combination with OPDIVO for advanced renal cell carcinoma. The company aims to provide insights on additional studies involving cabozantinib for other genitourinary cancers. Interested participants can access the briefing via Exelixis’ website, with a replay available for one year.
Exelixis, Inc. (NASDAQ: EXEL) reported retrospective analysis results of CABOMETYX® in treating brain metastases from renal cell carcinoma (RCC). Findings, presented at ASCO GU, indicate a 61% intracranial response rate for patients with progressive intracranial disease and 57% for those without. Median overall survival was 14.7 months for progressing patients and 14.1 months for others. The safety profile aligns with known data. These results suggest CABOMETYX may benefit patients with challenging brain lesions in RCC.
Bristol Myers Squibb (BMY) and Exelixis (EXEL) reported compelling results from the Phase 3 CheckMate -9ER trial for advanced renal cell carcinoma (RCC). The combination of OPDIVO® (nivolumab) and CABOMETYX® (cabozantinib) demonstrated significant improvements in progression-free survival (PFS) at 17.0 months compared to sunitinib's 8.3 months (HR 0.52). Overall survival (OS) also improved with a 34% reduction in death risk (HR: 0.66). Patients reported enhanced quality of life with fewer adverse events. These findings will be presented at the ASCO 2021 Symposium.
Exelixis, Inc. (Nasdaq: EXEL) announced that CEO Michael M. Morrissey, Ph.D., will participate in a fireside chat at the Guggenheim Healthcare Talks Oncology Day on February 11, 2021, at 11:30 AM EST. The event will be virtual due to COVID-19. Interested parties can access the webcast through the Exelixis website, where a replay will be available for 14 days post-event. Exelixis is known for its oncology-focused products, including CABOMETYX and COMETRIQ, and has been recognized as a leading biopharmaceutical company, ranking 17th in Fortune's 100 Fastest-Growing Companies.
Exelixis, Inc. (Nasdaq: EXEL) has entered into a collaboration with Adagene to utilize its SAFEbody™ technology platform for developing antibody-drug conjugates (ADCs) from Exelixis’ preclinical pipeline. Exelixis will pay $11 million upfront and can nominate two targets during the collaboration. This partnership aims to enhance safety and efficacy in ADCs by targeting tumor cells specifically while minimizing toxicity to healthy tissues. Adagene will receive milestones and royalties based on product sales. This agreement reflects Exelixis’ strategy to expand its biotherapeutics pipeline.
Exelixis, Inc. (Nasdaq: EXEL) will release its fourth quarter and full year 2020 financial results on February 10, 2021, after market close. Management will host a conference call at 5:00 p.m. EST to discuss the results and provide a business update. Investors can access the call via the company’s website, with replay options available through telephone and webcast for one year. Exelixis is known for its oncology-focused products, including CABOMETYX and COTELLIC, and was named one of Fortune’s 100 Fastest-Growing Companies in 2020.
Exelixis, Inc. (NASDAQ: EXEL) has initiated a first-in-human phase 1 trial for XL102, a selective CDK7 inhibitor, aimed at assessing its safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy in patients with advanced solid tumors. The XL102-101 trial will enroll up to 298 patients and includes a dose-escalation phase to identify the maximum tolerated dose, followed by a cohort expansion targeting ovarian, breast, and prostate cancer. Successful outcomes may enhance treatment options for patients with limited therapy alternatives.
Exelixis, Inc. announced FDA approval for CABOMETYX (cabozantinib) in combination with OPDIVO (nivolumab) as a first-line treatment for advanced renal cell carcinoma (RCC). This combination significantly improved efficacy measures compared to sunitinib, including doubling median progression-free survival (16.6 months vs. 8.3 months) and overall survival. The approval was based on the CheckMate -9ER trial results, showcasing a promising new standard of care for metastatic kidney cancer patients. The combination reflects a meaningful advancement in therapeutic options for this patient population.
Exelixis, Inc. (Nasdaq: EXEL) announced its preliminary financial results for Q4 and FY 2020, projecting 2021 revenues of $1.15 billion to $1.25 billion. Key drivers include FDA approval of CABOMETYX® with OPDIVO® for advanced renal cell carcinoma, targeting the U.S. market, estimated at $1.5 billion by 2022. R&D expenses are expected to rise to $600-$650 million, with a focus on expanding its oncology pipeline, including XL092, a next-gen treatment. The company ended 2020 with approximately $1.6 billion in cash. The comprehensive results will be released on February 10, 2021.
Exelixis, Inc. (Nasdaq: EXEL) announced that CEO Michael M. Morrissey, Ph.D., will present a corporate overview at the virtual 39th Annual J.P. Morgan Healthcare Conference on January 11, 2021, at 5:20 p.m. EST. Interested parties can access the webcast via Exelixis' website, with a replay available for 14 days. Founded in 1994, Exelixis focuses on oncology and has developed four products including CABOMETYX and COTELLIC. The company, ranked 17th on Fortune's 100 Fastest-Growing Companies list, aims to enhance its pipeline through strategic partnerships and internal research.