Welcome to our dedicated page for Exelixis news (Ticker: EXEL), a resource for investors and traders seeking the latest updates and insights on Exelixis stock.
Exelixis Inc. (symbol: EXEL) is a leading biopharmaceutical company that specializes in the discovery, development, and commercialization of small molecule therapies aimed at improving cancer treatment. Founded in the early 1990s, Exelixis has dedicated the past decade to establishing a robust development platform to bring new, effective cancer therapies to patients in need.
Exelixis’s flagship product, Cometriq® (cabozantinib), received its initial regulatory approval in late 2012 and has since been a cornerstone in the company’s portfolio. Cometriq is prescribed for the treatment of metastatic medullary thyroid cancer, while its variant Cabometyx is used for treating kidney and liver cancers.
Another significant achievement is the development and commercialization of Cotellic in partnership with Roche, targeted at melanoma treatment. These therapies have not only enhanced Exelixis’s market presence but also brought substantial improvements in patient outcomes.
Exelixis remains steadfast in its commitment to clinical excellence and patient care, consistently exploring new avenues for innovative cancer treatments. The company continues to engage in rigorous research and development activities, underpinned by strategic partnerships and collaborations.
Financially, Exelixis has shown solid performance with steady revenue growth driven by its commercial products and a promising pipeline of new therapies under development. The company’s dedication to research, patient care, and financial prudence makes it a notable entity in the biopharmaceutical landscape.
For more information about Exelixis and potential job opportunities, please visit their official website at www.exelixis.com.
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.
Exelixis (Nasdaq: EXEL) has expanded its collaboration with Invenra to include 20 additional oncology targets, enhancing their joint efforts to develop mono-specific and multi-specific antibodies for cancer treatment. Exelixis will pay Invenra an upfront fee of $15 million and additional fees for the new targets. The agreement allows Exelixis to own all antibody sequences discovered, with potential milestone payments for Invenra. This partnership aims to strengthen Exelixis' oncology pipeline and improve cancer therapy options for patients.
Exelixis reported impressive financial results for Q2 2021, with total revenues reaching $385.2 million, a 48% increase from Q2 2020. Net product revenues from CABOMETYX rose 59% year over year, driven by strong adoption of the CABOMETYX and OPDIVO combination therapy for renal cell carcinoma. The company has raised its revenue guidance for 2021, projecting total revenues between $1.3 billion and $1.4 billion. Key milestones include a supplemental NDA filing for cabozantinib in thyroid cancer and promising results from clinical trials.
Exelixis (NASDAQ: EXEL) announced the FDA's acceptance of its supplemental New Drug Application (sNDA) for CABOMETYX® (cabozantinib) to treat patients aged 12 and older with radioactive iodine-refractory differentiated thyroid cancer. The FDA has granted Priority Review, with a PDUFA target action date of December 4, 2021. The sNDA is based on promising results from the COSMIC-311 pivotal trial that indicated significant progression-free survival benefits. This development could position CABOMETYX as a critical treatment option for patients lacking standard care.
Exelixis, Inc. (Nasdaq: EXEL) will release its second quarter 2021 financial results on August 5, 2021, post-market close. A conference call is scheduled at 5:00 p.m. EDT to discuss the results and provide a business update. Access to the call will be available on their website and via phone. Exelixis focuses on oncology and has developed four commercial products, including CABOMETYX and COTELLIC, with ongoing partnerships to advance cancer therapies.
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