Exelixis Inc - EXEL STOCK NEWS

Exelixis, Inc. has initiated the dose-escalation stage of the STELLAR-002 trial, exploring XL092, a next-generation tyrosine kinase inhibitor, in combination with immuno-oncology therapies for advanced cancers. Collaborating with Bristol-Myers Squibb and Nektar Therapeutics, the trial aims to assess safety and efficacy among patients with advanced solid tumors. The study will focus on renal cell carcinoma, urothelial carcinoma, and metastatic castration-resistant prostate cancer, with primary endpoints including objective response rates and progression-free survival.

Exelixis plans to submit a supplemental New Drug Application (sNDA) to the FDA in early 2022 after presenting the first analysis of the COSMIC-312 phase 3 trial. This trial assesses the efficacy of cabozantinib with atezolizumab compared to sorafenib in treating advanced hepatocellular carcinoma (HCC). At 15.8 months follow-up, cabozantinib plus atezolizumab showed a 37% reduction in disease progression risk (PFS) versus sorafenib, though overall survival (OS) results were not statistically significant (HR: 0.90). The trial continues as planned for final OS analysis, anticipated in early 2022.

Exelixis has completed enrollment for its global phase 3 pivotal trial, CONTACT-01, assessing cabozantinib combined with atezolizumab in patients with metastatic non-small cell lung cancer (NSCLC) previously treated with an immune checkpoint inhibitor. The study includes 366 patients randomly assigned to either treatment or control arms, with overall survival as the primary endpoint. Following initial promising results from the COSMIC-021 trial, the company is optimistic about this combination and plans to share top-line results upon data maturity.

Exelixis (NASDAQ: EXEL) announced upcoming participation in several virtual investor conferences throughout November and December 2021. The management team will present at events including:

• BMO Biopharma Spotlight Series on November 8 at 12:10 p.m. ET
• Credit Suisse 30th Annual Virtual Healthcare Conference on November 10 at 1:50 p.m. ET
• Stifel 2021 Healthcare Conference on November 16 at 4:40 p.m. ET
• Piper Sandler 33rd Annual Virtual Healthcare Conference on November 22, available on demand
• Evercore ISI 4th Annual HealthConX Virtual Conference on December 1 at 11:45 a.m. ET

Webcast links can be accessed via Exelixis' website.

Exelixis, Inc. (Nasdaq: EXEL) reported strong Q3 2021 results with total revenues of $328.4 million, a significant increase from $231.1 million in Q3 2020. Net product revenues reached $263.1 million, boosted by the CABOMETYX and OPDIVO combination therapy. GAAP net income was $38.2 million or $0.12 per share, compared to a loss last year. Non-GAAP net income rose to $64.5 million, or $0.20 per share. The company updated its 2021 guidance to total revenues of $1.3 - $1.35 billion.

Exelixis, Inc. (Nasdaq: EXEL) announced it will release its third quarter 2021 financial results on November 2, 2021, after market close. A conference call and webcast will follow at 5:00 p.m. EDT (2:00 p.m. PDT) to discuss results and provide a business update. Interested parties can access the event on the company’s website. A replay will be available until 8:00 p.m. EDT on November 4, 2021. Exelixis focuses on oncology and has developed products like CABOMETYX and COTELLIC, aiming to enhance treatment options for patients with challenging cancers.

Exelixis and STORM Therapeutics have entered an exclusive collaboration for the development of novel cancer treatments, focusing on ADAR1 inhibitors. Exelixis will pay STORM $17 million upfront and fund research activities, assuming responsibility for global development and commercialization. This partnership aims to leverage STORM’s RNA-modifying enzyme platform to create differentiated small molecule therapies. ADAR1, which modulates innate immunity in tumors, presents significant therapeutic potential. The collaboration emphasizes Exelixis’ commitment to expanding its oncology portfolio.

Exelixis expands its oncology pipeline by exercising an exclusive option to in-license XL114, a promising anti-cancer compound, from Aurigene. The exercise involves a payment of $10 million and follows the FDA's acceptance of XL114's IND application. The upcoming phase 1 clinical trial for XL114 will target patients with Non-Hodgkin’s lymphoma. Preclinical data suggests XL114 effectively inhibits tumor growth, demonstrating its potential as a best-in-class therapy.

Exelixis announced final results from the phase 3 COSMIC-311 trial of CABOMETYX for treating radioactive iodine-refractory differentiated thyroid cancer (DTC). At a median follow-up of 10.1 months, patients treated with CABOMETYX experienced a median progression-free survival (PFS) of 11.0 months compared to 1.9 months for placebo. This data underpinned the recent FDA approval for CABOMETYX in the U.S. Notably, CABOMETYX significantly reduced the risk of progression or death (HR: 0.22). The safety profile aligns with previous findings, with manageable adverse events.