Exelixis Inc - EXEL STOCK NEWS

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.

Exelixis announced results from the expanded cohort 6 of the phase 1b COSMIC-021 trial, showing that cabozantinib combined with atezolizumab achieved a median progression-free survival of 6.8 months in high-risk metastatic castration-resistant prostate cancer (CRPC) patients. The trial, presented at the 2021 ESMO Congress, involved 132 patients, with a significant portion having measurable visceral metastases. Despite promising results, Exelixis will not pursue a regulatory submission for this combination therapy based on these findings.

Exelixis announced the FDA approval of CABOMETYX (cabozantinib) for treating radioactive iodine-refractory differentiated thyroid cancer (DTC) in adults and pediatric patients aged 12 and older. This approval is based on the COSMIC-311 phase 3 trial, which showed a statistically significant improvement in progression-free survival (PFS), with a median PFS of 11.0 months for CABOMETYX versus 1.9 months for placebo. The approval came more than two months ahead of the scheduled action date of December 4, 2021.

Exelixis (NASDAQ: EXEL) announced positive results from the phase 3 CheckMate -9ER trial, demonstrating significant efficacy benefits of CABOMETYX in combination with OPDIVO over sunitinib for patients with untreated advanced renal cell carcinoma, regardless of nephrectomy status. Key findings include:

• Median progression-free survival (PFS) of 19.4 months vs. 8.9 months for sunitinib.
• Overall survival (OS) hazard ratio of 0.54 among patients with prior nephrectomy.

The results highlight the combination's potential as a first-line treatment, promising improved outcomes for underserved patient subsets.

Exelixis, Inc. (NASDAQ: EXEL) mourns the loss of Gisela M. Schwab, M.D., Chief Medical Officer, who passed away after a medical leave since June 18, 2021. Her leadership and contributions significantly advanced the company’s clinical development efforts, transitioning Exelixis into a commercial biotechnology firm. The news follows the recent passing of Jon Berndt, Senior VP of Sales. Both were influential figures in the oncology field, leaving behind a legacy of dedication and impact on patient care.

Exelixis (Nasdaq: EXEL) announced participation in several virtual investor conferences in September 2021. The schedule includes:

• Morgan Stanley 19th Annual Global Healthcare Conference on September 9 at 1:15 PM EDT.
• H.C. Wainwright 23rd Annual Global Investment Conference available on-demand from September 13 at 7:00 AM EDT.
• BofA Securities Global Healthcare Conference on September 15 at 5:35 PM BST.
• Cantor 2021 Virtual Global Healthcare Conference on September 29 at 2:40 PM EDT.

Webcasts will be accessible via their website.

Exelixis announces that Takeda and Ono received approval from the Japanese Ministry of Health to market CABOMETYX in combination with OPDIVO for treating unresectable or metastatic renal cell carcinoma (RCC). This approval follows the success of the CheckMate -9ER trial, which showed that the combination significantly improved overall survival and doubled median progression-free survival compared to sunitinib. Exelixis is set to receive a $20 million milestone payment from Takeda upon the first commercial sale in Japan.