Exelixis Inc - EXEL STOCK NEWS

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.

Exelixis announced that the CONTACT-01 study failed to meet its primary endpoint of overall survival in patients with metastatic non-small cell lung cancer. This phase 3 trial evaluated cabozantinib combined with atezolizumab against docetaxel in patients who previously progressed on other therapies. The safety profile of the combination was consistent with known effects, with no new safety signals reported. Detailed findings will be presented at a future medical meeting.

Exelixis, Inc. (NASDAQ: EXEL) released initial results from the QUARTZ-101 trial, evaluating XL102, a CDK7 inhibitor for advanced solid tumors. The trial shows XL102 was well tolerated across five dose levels with 26 patients treated. Most common cancer types included hormone receptor-positive breast cancer, pancreatic cancer, and sarcoma. Although no objective responses were observed, two patients showed stable disease. The ongoing study will assess the safety and efficacy of XL102, with further evaluations planned in combination therapies.

Exelixis, Inc. (Nasdaq: EXEL) will participate in a fireside chat at the JMP Securities Hematology and Oncology Summit on December 7, 2022, at 12:00 pm ET. Access the webcast at www.exelixis.com. A replay will be available for 30 days.

Exelixis focuses on oncology, offering products like CABOMETYX®, COMETRIQ®, and COTELLIC®. The company aims to develop new therapies for challenging cancers, leveraging its established drug discovery platform.

Exelixis (Nasdaq: EXEL) announced management's participation in several investor conferences in November. Key presentations include: Stifel Healthcare Conference in New York on November 16, Jefferies London Healthcare Conference also on November 16, and Piper Sandler's Healthcare Conference in New York on November 29. Additionally, Exelixis will present virtually at the Evercore ISI HealthCONx on November 29. Webcast access and replays will be available on www.exelixis.com.

Exelixis (Nasdaq: EXEL) has entered a new licensing agreement with Catalent (NYSE: CTLT) for three oncology programs aimed at developing antibody-drug conjugates (ADCs) for various solid tumors. Exelixis will pay $30 million upfront for rights to the biologics programs and will fund the development until candidate selection. This collaboration enhances Exelixis’ biologics pipeline, targeting cancers including bladder, breast, and ovarian. Catalent's SMARTag technology will support the development, potentially improving treatment options for cancer patients.

Exelixis has entered into an exclusive agreement with Sairopa for the clinical development of ADU-1805, a monoclonal antibody targeting SIRPα, expected to improve immune response against tumors. An IND filing is anticipated in Q1 2023, which could expand Exelixis' clinical pipeline. The agreement includes a $40 million upfront payment and potential milestone payments totaling $70 million. ADU-1805 shows promise against multiple tumor types and might have a better safety profile than existing therapies.

Exelixis has formed an exclusive collaboration with Cybrexa Therapeutics to acquire CBX-12, a novel peptide-drug conjugate designed to enhance cancer treatment efficacy while reducing toxicity. The collaboration underscores Exelixis' commitment to expanding its clinical pipeline. Exelixis will pay an upfront fee of $60 million plus potential milestone payments up to $642.5 million. Initial data from a Phase 1 trial of CBX-12 indicate promising anti-tumor activity, including complete response in a patient with ovarian cancer, highlighting its potential in treating diverse tumors.

Exelixis reported Q3 2022 total revenues of $411.7 million, a 25% year-over-year increase, driven mainly by cabozantinib franchise revenues of $366.5 million, which showed 39% growth year-over-year. GAAP diluted EPS was $0.23, and non-GAAP diluted EPS was $0.31. R&D expenses rose to $198.8 million due to increased clinical trial costs. The company provided updated 2022 financial guidance, expecting total revenues between $1.575 billion and $1.600 billion, with net product revenues of $1.375 billion to $1.400 billion.