Exelixis Inc - EXEL STOCK NEWS

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.

Exelixis announced that the COSMIC-311 phase 3 trial for cabozantinib (CABOMETYX) in patients with radioiodine-refractory differentiated thyroid cancer met its co-primary endpoint, showing a significant 78% reduction in risk of disease progression or death (hazard ratio 0.22, p<0.0001). Following these interim results, the independent monitoring committee recommended stopping enrollment. The company plans to discuss these results with the U.S. FDA and share detailed findings at an upcoming medical conference, marking a significant advancement in treatment options for this patient population.

Exelixis, Inc. (Nasdaq: EXEL) has exercised its exclusive option for Iconic Therapeutics' leading oncology antibody-drug conjugate (ADC) program, XB002. This program targets Tissue Factor (TF) and includes Zymeworks' linker-payload technology, aiming for a better safety profile. Exelixis will be responsible for the clinical development and commercialization of XB002. An additional payment of $20 million has been made to Iconic following the initial $7.5 million payment from a 2019 agreement. Exelixis plans to file an IND application with the FDA to start a Phase 1 clinical trial in early 2021.

Exelixis, Inc. (NASDAQ: EXEL) announced that its partner, Takeda Pharmaceutical, received approval from Japan's Ministry of Health to market CABOMETYX^® (cabozantinib) for unresectable hepatocellular carcinoma (HCC) patients who have failed prior systemic therapy. This approval is based on results from the CELESTIAL and Cabozantinib-2003 clinical trials. Exelixis is eligible for a $15 million milestone payment upon first commercial sale, expected in Q4 2020. The collaboration with Takeda includes potential future milestones and royalties on net sales in Japan.